Capsule-Preserving Hydrodilatation With Corticosteroid Versus Corticosteroid Injection Alone in Refractory Adhesive Capsulitis of Shoulder: A Randomized Controlled Trial

Accepted Manuscript Capsule-preserving hydrodilatation with corticosteroid versus corticosteroid injection alone in refractory adhesive capsulitis of shoulder: a randomized controlled trial Doo-Hyung Lee, MD, PhD, Seung-Hyun Yoon, MD, PhD, Michael Young Lee, MD, MHA, Kyu-Sung Kwack, MD, PhD, Ueon Woo Rah, MD, PhD PII:

S0003-9993(16)31232-1

DOI:

10.1016/j.apmr.2016.10.012

Reference:

YAPMR 56720

To appear in:

ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION

Received Date: 22 August 2016 Revised Date:

20 October 2016

Accepted Date: 21 October 2016

Please cite this article as: Lee D-H, Yoon S-H, Lee MY, Kwack K-S, Rah UW, Capsule-preserving hydrodilatation with corticosteroid versus corticosteroid injection alone in refractory adhesive capsulitis of shoulder: a randomized controlled trial, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2016), doi: 10.1016/j.apmr.2016.10.012. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Short running head: hydrodilatation for adhesive capsulitis

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Title: Capsule-preserving hydrodilatation with corticosteroid versus corticosteroid injection alone in refractory adhesive capsulitis of shoulder: a randomized controlled trial

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Authors: Doo-Hyung Lee, MD, PhD, Seung-Hyun Yoon, MD, PhD, Michael Young Lee,

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MD, MHA, Kyu-Sung Kwack, MD, PhD, Ueon Woo Rah, MD, PhD

Affiliation: Department of Orthopedic Surgery (D.-H. Lee), Physical Medicine and Rehabilitation (S.-H. Yoon and U.W. Rah), and Radiology (K.-S. Kwack) Ajou University School of Medicine, Suwon, Republic of Korea

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Department of Physical Medicine and Rehabilitation (M.Y. Lee), University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC

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Corresponding author: Seung-Hyun Yoon, MD, PhD, Department of Physical Medicine and Rehabilitation, Ajou University School of Medicine, Worldcup-ro 164, Yeongtong-gu,

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Suwon 16499, Republic of Korea, e-mail: [email protected], Telephone: +82-31-2195279

Clinical Trial No.: KCT0002006 (https://cris.nih.go.kr)

This manuscript is not published previously, and will not be submitted for publication elsewhere.

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Key Words: Adhesive capsulitis; Frozen shoulder; Painful stiff shoulder; Corticosteroid;

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Shoulder pain; Ultrasonography; Injections

Conflict of interest: none declared.

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Financial support: none declared.

Acknowledgement

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We thank Aeree Park, MA, for the English translation of the Korean manuscript.

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Written permission has been obtained from person named in the Acknowledgments.

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Title: Capsule-preserving hydrodilatation with corticosteroid versus corticosteroid injection

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alone in refractory adhesive capsulitis of shoulder: a randomized controlled trial

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Objective: To determine whether capsule-preserved hydrodilatation with corticosteroid

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(CPHC) improves pain and function in patients with refractory adhesive capsulitis (AC) better

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than intra-articular corticosteroid injection (IACI) alone.

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Design: Prospective randomized controlled study.

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Setting: University-affiliated tertiary care hospital.

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Participants: Primary AC subjects (N=64) with shoulder pain level of visual analogue scale

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(VAS) ≥ 5 even after the initial administration of IACI alone.

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Interventions: Participants randomly received ultrasound-guided IACI alone with 1 mL of 40

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mg/mL triamcinolone acetonide and 3 mL of 1% lidocaine (n = 32), or ultrasound-guided

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CPHC with a mixture of 1 mL of 40 mg/mL triamcinolone acetonide, 6 mL of 1% lidocaine

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and normal saline (n = 32).

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Main Outcome Measures: The primary outcome measure was the Shoulder Pain and

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Disability Index score. Secondary outcomes were VAS of the shoulder pain level and angles

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of shoulder passive range of motion including flexion, abduction, extension, external rotation,

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and internal rotation at pre-treatment and week 3, 6 and 12 of post-treatment.

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Results: There were no significant differences between 2 groups in terms of demographic

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ACCEPTED MANUSCRIPT characteristics (age, sex, duration of symptoms, shoulder affected, and body mass index) at

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baseline. Repeated-measures analysis of variance showed significant effect of time in all

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outcome measurements in both groups. But group-by-time interactions were not significantly

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different for any of the outcomes between groups.

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Conclusion: This study shows that compared to pre-treatment, all outcome measures

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improved significantly in both groups by time, however, there was no significant difference

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between the two groups. Therefore, we recommend IACI alone over CPHC when considering

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the corticosteroid injection as secondary option after the initial IACI fails to improve

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symptoms for patients with refractory AC.

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Key Words: Adhesive capsulitis; Frozen shoulder; Painful stiff shoulder; Corticosteroid;

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Shoulder pain; Ultrasonography; Injections

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List of abbreviations:

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AC, adhesive capsulitis

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ANOVA, analysis of variance

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CPHC, capsule-preserved hydrodilatation with corticosteroid

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IACI, intra-articular corticosteroid injection

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MRI, magnetic resonance imaging

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ACCEPTED MANUSCRIPT ROM, range of motion

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SPADI, Shoulder Pain and Disability Index

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VAS, visual analogue scale

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ACCEPTED MANUSCRIPT Hydraulic arthrographic capsular distension (hydrodilatation) is a useful treatment

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which quickly improves the contracture and pain of adhesive capsulitis (AC) by injecting

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sufficient amount of fluid in the shoulder capsule. Andren and Lundberg first described

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hydrodilatation for patients with AC in 1965.1 Since then, there have been over thirty studies

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reporting the therapeutic effects of hydrodilatation.1-13 Local anesthetic and saline are usually

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used as fluid which is injected into the joint during hydrodilatation. Most researchers mix

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corticosteroid in the fluid to enhance the effect of hydrodilatation because this would quickly

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reduce the inflammation of the capsule.2, 3, 5, 8, 9, 11, 12

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However, compared to the non-hydrodilatation (intra-articular corticosteroid

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injections (IACI) alone), the hydrodilatation technique has several disadvantages including

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severe complaints related to pain and time-consuming procedures which require cumbersome

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preparations. Also, even a single IACI alone is enough to show clear improvement in the

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symptoms of most patients with AC.14-16 Therefore, it is more adequate to use hydrodilatation

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as secondary treatment option when the IACI alone used as primary fails to show

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improvement in the symptoms of patients with AC.17

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In this study, we defined refractory AC as having sustained pain (visual analogue

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scale, VAS ≥5) and limited range of motion (ROM) of shoulder even after the administration

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of a single IACI; a minimum of 6 weeks of observational period was also secured prior to the

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diagnosis. It must also be noted that once IACI fails, not many other treatments exist as

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secondary options. Perhaps a second round of IACI or hydrodilatation injection can be

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considered, and a manipulation under anesthesia or surgical release could follow.18,

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However, such aggressive treatments as manipulation or surgery are not used often.20 The

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rationale for 6 observational weeks can be found in Cochrane’s 2003 review which stated that

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the corticosteroid injection only had short-term benefit for shoulder pain21; on the fact that

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triamcinolone acetonide’s duration of action after the intra-articular injection is 2 to 3 weeks22;

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and in a separate study which observed patients with AC for 12 months post-injection and

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reported significant difference between IACI and placebo from week 6.23 Therefore, 6 weeks

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was deemed sufficient enough for evaluating the effect of IACI by the authors.

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As for the hydrodilatation technique, many researchers distended the joint capsule

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until it ruptured,1, 3-7 believing that the increasing intra-articular pressure might rupture the

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capsule at its tightest point and result in clinical improvement. However, most ruptures during

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hydrodilatation occurred at the subscapularis bursae or biceps sheath,6,

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thickened capsule where the actual pathologies of AC exist.25-27 Therefore, recent study

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results claim that the use of hydrodilatation while preserving the capsule at maximum volume

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has a superior effect than the aggressive rupturing method, the latter rather aggressive

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treatment can slow down improvement by inflicting injury in the normal structure.8, 10, 13, 28

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not at the

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This study attempted to find out whether or not there is a difference in effect between

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the IACI alone and hydrodilatation with corticosteroid when performing a secondary

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ACCEPTED MANUSCRIPT corticosteroid injection to patients with refractory AC who exhibit continuous symptoms even

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after the administration of a single IACI alone. Based on the previous literatures on

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hydrodilatation technique which claim the capsule-preserved hydrodilatation to be more

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physiological and improve AC faster than the aggressive hydrodilatation,8, 10, 13, 28 the authors

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of this study selected the former methodology for the study of this research. The aim of this

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study is to determine whether or not the capsule-preserved hydrodilatation with corticosteroid

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(CPHC) improves pain and function in patients with refractory AC better than IACI alone.

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Methods

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Participants

Participants were outpatients at rehabilitation clinic of a university-affiliated tertiary

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care hospital and who were diagnosed with primary AC between June 2010 and May 2012.

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All participants underwent a standardized history, physical examination, and ultrasonographic

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evaluation. We tested out active and passive ROM, painful arc/impingement test, resisted test,

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and strength of muscles in the affected shoulder. The participants were also given an

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ultrasound-guided intra-articular injection with 1 mL of 40 mg/mL triamcinolone acetonide

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and 3 mL of 1% lidocaine after being diagnosed as AC. During the observational period of 6

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weeks, we handed out picture leaflets and instructed the patients about the home exercise

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program for increasing the ROM including stretching forward and bending down to a desk,

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Codman exercise, wall-climbing exercise, external and internal rotation with bar, and

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posterior shoulder stretch. Exercises were to be performed 3 times a day lasting 10 minutes

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each round. Inclusion criteria were patients who had refractory AC; primary AC with a normal

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radiograph finding of the affected shoulder and limitation of passive motion of greater than

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30˚ in two or more planes of movement5; and aged 40 to 65 years. Participants were excluded

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if they had any of the following: partial- or full-thickness tear of the rotator cuff on

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ultrasonography or magnetic resonance imaging (MRI); secondary AC (secondary to other

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causes including metabolic, inflammatory, or infectious arthritis; stroke; tumor; or fracture);

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calcification of the rotator cuff, demonstrated by simple radiography or ultrasonography;

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disorders of the biceps tendon or acromioclavicular joint; presence of another medical or

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psychological condition, including cancer, rheumatoid arthritis, uncontrolled diabetes, or

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major depression; primary osteoarthritis of the glenohumeral joint in a simple radiograph;

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previous corticosteroid injection history at the affected shoulder; and those with workers’

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compensation benefit. MRI was not undertaken routinely, but those with either muscle

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weakness or positive impingement sign were excluded because of a high suspicion of rotator

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cuff tear.

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The study was approved by the institutional review board at the university hospital, and all participants gave written informed consent.

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Sample size The required sample size was calculated based on a previous study on the

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hydrodilatation of AC.5 Mean Shoulder Pain and Disability Index (SPADI) score of treatment

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(40mg methylprednisolone acetate) and control groups showed significant difference during

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the 12 week treatment. A power analysis program was used to calculate the number of

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participants required29; with an alpha of .05, 90% power, effect size f of .37, 2 groups, 15

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standard deviations and 3 repetitions, we obtained a minimum sample size of 56. Considering

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the potential drop-out rate of 15%, the final total sample size was 64.

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Design and Randomization

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This is a prospective randomized controlled trial. A schematic diagram of the study is

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shown in the figure 1 below. A total of 235 participants with AC in moderate to severe pain

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(VAS≥5) were recruited. Of them, 168 patients showed improved clinical outcomes after

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performing the ultrasound-guided IACI. Out of 67 refractory AC patients who complained of

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continuous pain of VAS≥5 even after the observational period of 6 weeks since the injection

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of a single IACI, all but 3 who refused participated in the research. These 64 participants were

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randomly assigned to the CPHC or IACI group by a block randomization method.30 A

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computerized random number generator and table were used to perform group allocations,

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which were performed by an assistant (other than the authors).

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Intervention All the injections administered were performed by a board certified physiatrist (lead

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author) with ultrasound equipmenta using 10- to 12-MHz linear array transducer. Participants

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sat in an upright position with their hands positioned on their thighs.31, 32 A 21-gauge, 6 cm

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long needle was inserted parallel to the ultrasound probe in a semi-oblique plane from the

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posterior aspect of the shoulder. The needle was administered under real-time ultrasound until

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the tip of the needle entered the glenohumeral joint.16 An injection of 1 mL of 40 mg/mL

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triamcinolone acetonide and 3 mL of 1 % lidocaine was given slowly in IACI group. For

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CPHC group, normal saline was given after the injection of a fluid mixture composed of 1 mL

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of 40 mg/mL triamcinolone acetonide and 6 mL of 1% lidocaine. The expansion of the

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articular capsule was checked with ultrasonography while the fluid was being injected. The

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rate of normal saline infusion was maintained at 0.25 mL/s to prevent rupture caused by an

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abrupt volume increase within the capsule. A small syringe of 10mL was used to allow the

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administrator to feel the intra-articular pressure sufficiently on his finger through the plunger

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during the infusion. The injection was paused at a point when the ultrasonography showed no

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further distension of the capsule; resistance was felt through the plunger as a result of elevated

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intra-articular pressure; or the participant requested to stop due to pain. After pausing for 10

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ACCEPTED MANUSCRIPT seconds while still maintaining the plunger’s pressure, the injection was resumed up to 5

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times until no more saline went in at which point the hydrodilatation procedure was

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terminated. Upon termination of the procedure, the capsule dilatation was confirmed through

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an ultrasonographic image. The decision of a rupture was made when the resistance that was

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felt through the plunger reduced abruptly during the infusion and the size of the distended

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capsule shrank in the ultrasonographic image. The participants were told not to move their

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shoulders as much as possible for at least 3 hours to avoid rupture. Once the procedure was

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over, we handed out picture leaflets and instructed the participants about the home exercise

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program. The participants were also encouraged to keep an exercise diary to track their

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exercise frequency, duration and any difficulties. The diaries were checked at each follow-up

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visit. Calls were also made to participants to encourage continuous exercises and remind them

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not to take any additional physical agents or medication.

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Outcome measurements

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Treatment efficacy was evaluated at pretreatment, and week 3, 6 and 12 after the

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injection by the evaluator who was not informed of the injection method. The primary

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outcome measure was SPADI, a self-reporting questionnaire for patients with shoulder pain,

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which consists of 13 questions that are divided into two domains: pain (5 items) and disability

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(8 items).33 Each domain score is equally weighted and added to get a total percentage score

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ACCEPTED MANUSCRIPT between the ranges 0 (best) to 100 (worst). Secondary outcome measures included VAS for

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global shoulder pain and shoulder passive ROM. The passive ROM was measured by

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goniometer, forward flexion and abduction in supine position, and extension lying on the side

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of unaffected limb. External and internal rotations were measured in 90° abduction of

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shoulder and 90° flexion of elbow position. If abduction measured was less than 90°,

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maximum possible abduction was achieved before measuring the external and internal

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rotations. The patient was positioned to the same degree of abduction to measure the external

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and internal rotations during the follow-up.

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Statistical analysis

After a normality test, we compared the two groups in terms of age, sex, duration of

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symptoms, shoulder affected (dominance), and body mass index by performing independent t-

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or chi-square analysis. The effect of injection during 12 weeks was evaluated with repeated-

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measures analysis of variance (ANOVA). Significance was accepted for p values of less

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than .05. All these analyses were performed using SPSS statistical softwareb.

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Results

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Among those recruited, all 64 participated in the follow-up until week 12. Table 1

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lists baseline characteristics of study subjects. There were no significant differences between

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ACCEPTED MANUSCRIPT two groups in terms of age, sex, duration of symptoms, shoulder affected, and body mass

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index (p>.05). Table 2 shows the changes of outcome measurements after the injection.

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Repeated-measures ANOVA showed significant time interaction in all of the outcome

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measurements (p<.001). This means that compared to pre-treatment, all of the outcome

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measures improved significantly in both groups by time. But none of the group-by-time

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interactions showed significant difference of outcomes between groups. This means that there

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was no significant difference between both groups.

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Rupture occurred in 2/32 (6.25%) of the participants belonging to the CHC group.

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The average volume infused in CPHC group was 25.1 ± 6.1 mL, including that of those who

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experienced rupture. There were no serious complications, such as infection, other than facial

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flushing on days 2 to 5 after injection (one participant in IACI group, and two in CPHC) and

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dizziness due to vasovagal reaction during the injection (three in CPHC group).

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Discussion

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This study observed participants who received either IACI alone or CPHC as

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secondary corticosteroid injection for a period of 12 weeks. Both groups showed

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improvement in all outcomes after the injection, however, there was no significant difference

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between the two groups. Therefore, we believe the effect of corticosteroid, which reduces

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inflammation and alleviates pain, to be the major mechanism behind such improvement in

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outcome, while the contribution of the mechanical effect of hydrodilatation procedure is very

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meager, if not none at all. Although there are numerous studies which have reported favorable results on

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hydrodilatation, most have included corticosteroid which makes it rather difficult to attribute

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the benefit directly to the joint distension.2, 3, 5, 8, 9, 11, 12 Two comparative studies have found

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no benefit of hydrodilatation combined with corticosteroid over corticosteroid alone.2,

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Furthermore, two randomized controlled trials reported a finding which also supports our

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claim that it is the use of corticosteroid, rather than the hydrodilatation itself, that is impacting

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the result; three or four injections of hydrodilatation with corticosteroid or corticosteroid

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alone (non-hydrodilatation) were administered and observed for 6 or 8 weeks, rendering no

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difference in the outcomes (SPADI, pain intensity, and passive ROM) between the two

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groups.9, 34 Our study recruited patients with refractory AC and, based on the recent studies,

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tried to preserve the capsule as much as possible.

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Contrary to the results of previous, as well as our studies, in a study by Yoon et al,12

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hydrodilatation with corticosteroid group had better outcomes than corticosteroid alone group

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in terms of the VAS score for pain and ROM up to 1 month and functional scores up to 3

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months. Their study included subjects with AC in the frozen phase, and claimed that

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hydrodilatation may be more effective in the frozen phase than in an earlier inflammatory

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phase. Based on their claim, perhaps there wasn’t any difference in the effect between IACI

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ACCEPTED MANUSCRIPT and CPHC because most of our subjects were in the early inflammatory phase. If indeed there

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is a difference in the effect of CPHC depending on the phase, then the method of IACI should

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be tailored to follow the course of the disease. For example, if pain is severe but limitation

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mild, IACI alone should be enough, however, with a more severe limitation, hydrodilatation

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can be of further help.

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Based on recent studies which state that the capsule-preserving distension with

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maximal volume is more effective for AC treatment than the capsule-rupturing through

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aggressive distension,8, 10, 13 we selected CPHC as our hydrodilatation technique in this study.

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We maintained a very slow rate of saline infusion at 0.25 mL/s to prevent rupture caused by

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an abrupt volume increase within the intra-articular cavity. A small 10 mL syringe was used

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to allow the administrator to fully feel the intra-articular pressure on his finger through the

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plunger during the infusion. When there was resistance felt during the infusion, the injection

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was paused for 10 seconds while still maintaining the plunger’s pressure. The injection was

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then resumed up to 5 times until no more saline went in and the hydrodilatation procedure

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was terminated. Although difficult to make any direct comparison due to different attributes

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of participants and methodologies of infusion, we injected sufficient amount of volume

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compared to previous studies with CPHC methods (25.1 ± 6.1 mL in this study vs. 29.0 ± 8.39

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to 32.8 ± 7.7713 and 20.2 ± 5.2 mL8) and got a low capsule-rupture rate of 6.25 percent as a

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result.

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ACCEPTED MANUSCRIPT To our best knowledge, this is the first study to evaluate the efficacy of

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hydrodilatation as a treatment option in patients with refractory AC. Since a single IACI alone

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seems effective enough to show satisfactory results in most patients with AC,14-16 there is not

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enough rationale to support a hydrodilatation treatment with corticosteroid as initial

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therapeutic option. In fact, compared to IACI alone, the hydrodilatation procedure with

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corticosteroid takes up longer hours to complete while resulting in a more severe complaint

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related to pain. Although not so serious, our study also had 3 participants (9.4%) from CPHC

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group who complained about complications such as dizziness due to the vasovagal reaction or

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pain during the injection. Also, an aggressive hydrodilatation treatment may possibly slow

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down improvement by inflicting an extensive injury in the capsule; reducing the anti-

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inflammatory effect and causing local side effect such as tendinopathy because the

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corticosteroid will not be able to stay within the intra-articular cavity. There are claims that

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hydrodilatation can be more helpful than IACI alone in some patients (e.g. 67/235 (28.5%)

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participants in this study) who complain about moderate to severe pain (VAS ≥5) even after

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the administration of IACI.17 However, our study showed the same improvement in outcomes

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for both groups, without any difference in effect between the CPHC with corticosteroid and

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IACI alone even in patients with refractory AC who failed the initial IACI alone. Such result

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can help to provide a therapeutic guideline for patients with refractory AC.

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Although we have not performed any manipulation with IACI or CPHC in our study,

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ACCEPTED MANUSCRIPT combination treatment such as hydrodilatation with manipulation is a method that has been

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used to treat AC.35 A study which compared manipulation alone and manipulation combined

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with intra-articular corticosteroid injection reported that there is no benefit in adding the intra-

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articular corticosteroid injection.36 Another study claimed that although no difference was

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found in pain, function, or quality of life compared to placebo (sham ultrasound) in manual

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therapy after hydrodilatation, some positive results were shown in the active ROM and

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participant-perceived improvement.37

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Study limitations

Several limitations should be noted in interpreting our findings. First, we tried to

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perform the distention with maximal volume by infusing the saline at a very slow rate during

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the CPHC. But without the real-time pressure monitoring of intra-articular pressure, we had to

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depend on the administrator’s subjective senses for pressure. Therefore, it is possible to have

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achieved an insufficient amount of distension or an early capsular rupture. Second, since we

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did not include a placebo group in our study, the improved outcomes of the two groups may

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have been due to the placebo effect or possibly a natural course of improvement with time.

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Third, we have not been able to perform an MRI for all the participants. Since the diagnoses

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and selection of our participants were based on our physical examination, radiographs and

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ultrasonography, it is possible to have included some with small rotator cuff tears or labral

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ACCEPTED MANUSCRIPT lesions. Fourth, the authors recruited participants with refractory AC who had continuous pain

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and limited ROM even after the administration of IACI and minimum 6 weeks of

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observational period. But despite 6 weeks of observational period, the primary IACI may

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have impacted the effect of secondary IACI or CPHC. Fifth, participants were not blinded to

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the injection methods. Although there was no difference in outcomes between the two groups,

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these participants may have thought the effect of CPHC is better than the IACI alone, which

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could have affected the subjective evaluation on pain. Finally, the participants were told not to

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move their shoulders for at least 3 hours after CPHC to avoid rupture. However, they were not

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monitored during the 3 hours post-injection to track whether or not they actually moved their

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shoulders or if any rupture took place due to such movement.

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Conclusion

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This study, which performed either CPHC or IACI alone and subsequently followed-

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up participants with refractory AC whose symptoms did not show improvement even after a

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single IACI for 12 weeks, found that there was an improvement in the outcomes after more

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than before the injection in both groups; but no difference was found between the groups.

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Therefore, we recommend IACI over CPHC, when considering a second corticosteroid

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injection after the failure of the initial IACI.

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References

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Arthrography. Acta Orthop Scand 1965;36:45-53.

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shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis

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400

a. Logiq P6, GE Healthcare, Buckinghamshire, United Kingdom

401

b. SPSS version 22, IBM Inc, Armonk, NY, USA

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Figure 1. Flow diagram indicating progress of participants through the study.

403

CPHC,

404

corticosteroid injection; VAS, visual analogue scale.

hydrodilatation

with

corticosteroid;

IACI,

intra-articular

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capsule-preserved

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Table 1. Baseline characteristics of subjects IACI group (n=32)

Age, years

CPHC group (n=32)

53.8 ± 4.4

Sex, men: women

13:19

7.8 ± 1.7

Shoulder affected, 10:22

M AN U

dominant: non-dominant Body mass index, kg/m2

55.9 ± 5.2

.08*

11:21

.61†

8.2 ±1.5

.33*

SC

Duration of symptoms, months

p

RI PT

Characteristics

24.8±2.6

13:19

.80†

25.4±2.7

.36*

Values are expressed as n, or mean ± SD. CPHC, capsule-preserved hydrodilatation with corticosteroid; IACI, intra-articular corticosteroid injection. Independent t-test for between-group comparison (p<.05).

†

Chi-square test for between-group comparison (p<.05).

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*

ACCEPTED MANUSCRIPT Table 2. Changes of outcome measurements after corticosteroid injection.

Outcome IACI group (n=32)

CPHC group (n=32)

Time effect*, p

measurements <.001

Week 0

56.5±9.6

61.1±10.4

Week 3

33.4±15.1

32.5±15.4

Week 6

22.3±13.9

28.6±11.7

Week 12

19.7±11.5

25.7±10.3

<.001

6.3±1.1

6.8±1.5

Week 3

3.8±1.7

3.4±1.5

Week 6

2.5±2.1

2.1±1.7

Week 12

2.0±1.9

Flexion 129.1±13.8

Week 3

151.0±13.8

Week 6

154.7±15.6

Week 12

156.9±10.7

Abduction

106.9±24.2

111.1±22.8

Week 6

116.0±27.2

113.9±24.9

Week 12

121.2±26.6

118.1±24.3

EP

.388

<.001

.233

<.001

.967

<.001

.909

160.4±8.5

Week 3

30.1±10.7

27.6±10.3

39.2±10.5

40.3±11.2

Week 6

42.3±9.6

43.9±10.5

Week 12

44.2±10.3

44.7±8.8

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<.001

158.2±10.7

78.5±21.9

Week 3

.296

156.8±13.6

83.8±19.8

Week 0

<.001

138.6±17.7

Week 0

Extension

.202

1.8±1.8

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Week 0

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Week 0

.134

SC

VAS

interaction*, p

RI PT

SPADI

Group-by-time

Internal rotation Week 0

32.5±11.1

28.4±10.4

Week 3

46.6±11.5

42.3±13.5

Week 6

52.5±16.0

46.3±13.3

Week 12

55.8±15.9

49.5±14.6

External rotation Week 0

29.8±13.9

35.4±16.6

Week 3

41.7±12.9

49.0±19.1

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ACCEPTED MANUSCRIPT Week 6

44.8±12.2

52.4±15.0

Week 12

46.4±10.7

53.7±15.3

Values are expressed as mean ± SD. CPHC, capsule-preserved hydrodilatation with

RI PT

corticosteroid; IACI, intra-articular corticosteroid injection; SPADI, Shoulder Pain and Disability Index; VAS, visual analog scale.

EP

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SC

Repeated-measures ANOVA (p<.05).

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*

2

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