Effectiveness of Kinesio taping in the treatment of somatosensory tinnitus: A randomized controlled trial

Effectiveness of Kinesio taping in the treatment of somatosensory tinnitus: A randomized controlled trial

Complementary Therapies in Clinical Practice 39 (2020) 101100 Contents lists available at ScienceDirect Complementary Therapies in Clinical Practice...

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Complementary Therapies in Clinical Practice 39 (2020) 101100

Contents lists available at ScienceDirect

Complementary Therapies in Clinical Practice journal homepage: http://www.elsevier.com/locate/ctcp

Effectiveness of Kinesio taping in the treatment of somatosensory tinnitus: A randomized controlled trial a € �ba Atan a, *, Dog �an Atan b, Sumru Ozel Tug a b

Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Hitit University, Corum, Turkey Department of Otorhinolaryngology, Faculty of Medicine, Hitit University, Corum, Turkey

A R T I C L E I N F O

A B S T R A C T

Keywords: Kinesio taping Neck pain Somatosensory tinnitus

Background and purpose: The clinical effects of Kinesio taping (KT) for somatosensory tinnitus have not been confirmed. The purpose of this study is to investigate the efficacy of KT applied to the sternocleidomastoid, upper trapezius, and levator scapulae muscles for somatosensory tinnitus associated with neck complaints. Materials and methods: Thirty-patients were randomly assigned to the KT group (n ¼ 15) and the sham-taping (ST) group (n ¼ 15). Tinnitus-severity was measured using a visual analog scale (tinnitus-VAS) as a primary outcome. Tinnitus Handicap Inventory (THI), cervical pain-VAS, and neck disability index (NDI) were used for the assessments of tinnitus handicap, neck pain, and disability. Results: Tinnitus-VAS, THI, cervical pain-VAS, and NDI improved significantly in the KT group after the inter­ vention (all P � 0.001). In the ST group, no significant differences in outcome measures were found in the fourthweek. Conclusion: KT is more effective than sham-taping in improving somatosensory tinnitus associated with neck complaints.

1. Introduction Tinnitus is defined as an annoying perception of sound that is heard without any actual external acoustic stimulation. It affects 10–15% of adults and is often subjective [1]. Subjective tinnitus is usually perceived as a non-specific hum, tonal sound, hiss, ring, or roar and may be trig­ gered by various causes. It is often accompanied by hearing loss which is associated with ototoxic drug use, psychological stress, and a range of medical conditions that can affect hearing function. This is defined as “otic tinnitus” [2–4]. In some individuals, tinnitus may also originate from complex somatosensory–auditory interactions related to the musculoskeletal system rather than the ear, which is defined as “somatosensory tinnitus”. This specific subgroup includes 65% of patients. Temporomandibular joint, craniocervical junction, cervical vertebrae and neck, and shoulder muscles, especially the sternocleidomastoid (SCM) muscle, upper trapezius, and levator scapulae, are the anatomic sites for the symptom. Previous studies have shown that modulation of tinnitus by specific maneuvers (jaw and neck movements, pressure application on

myofascial trigger points and, rarely, extremity movements) of these anatomic regions may be possible [2,5–7]. Various therapeutic procedures, such as a cervical collar for cervical pain syndrome [8], transcutaneous electrical nerve stimulation [9,10], laser therapy [11], deactivation of myofascial trigger points [12], cer­ vical manual therapy, exercises [13] and repetitive transcranial mag­ netic stimulation with peripheral muscle magnetic stimulation [14] have been performed to treat somatosensory tinnitus. Cervical spine treatments have shown positive effects on somatosensory tinnitus in several studies [6]; however, these studies are limited due to the small number of patients and lack of control groups and randomization [6, 8–13]. It is evident that, even if the somatosensory tinnitus is correctly diagnosed, there is no specific treatment yet [6,15]. Kinesio taping (KT) is a therapeutic taping technique, invented by Dr. Kenzo Kase in 1970s. Kinesio tape is an elastic cotton strip that can be stretched up to 40–60% of its resting length. KT relieves tension in the neck area, lifts trigger points, provides mobility to the tissue, and im­ proves blood and lymphatic flow [16,17]. The authors of this study hypothesize that the application of KT

* Corresponding author. Hitit University Faculty of Medicine Corum Erol Olcok Research and Training Hospital, Department of Physical Medicine and Rehabil­ itation, Corum, Turkey. E-mail address: [email protected] (T. Atan). URL: https://orcid.org/0000-0003-1229-8679 (T. Atan). https://doi.org/10.1016/j.ctcp.2020.101100 Received 12 March 2019; Received in revised form 16 January 2020; Accepted 16 January 2020 Available online 21 January 2020 1744-3881/© 2020 Elsevier Ltd. All rights reserved.

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would also help relieve tinnitus. This study aims to identify the effect on somatosensory tinnitus associated with neck complaints when KT is applied to the SCM, upper trapezius, and levator scapulae muscles.

assignment and containing information about the group allocation in opaque, sealed envelopes were prepared by the independent individual. The physician opened the envelope and applied the taping according to the group. All patients were blinded to treatment allocation. KT (Kinesio Tex Gold, 2 in � 103.3 ft) was applied, in the experi­ mental group, to SCM, upper trapezius, and levator scapulae muscles by muscle inhibition technique (from insertion to origin points of a muscle) as defined by Dr. Kenzo Kase (Fig. 1) [21]. The patients were seated on a chair and the application for SCM muscle started. The anchor (initial part of the “Y-tape”) was attached to the mastoid process without strain, while the patients turned their head away to the side in which the tape was to be applied and bent their necks laterally. The tail of the tape was attached to the clavicular portion and sternal portion without stretching. Thereafter, the anchor of an “I-tape” was attached to the acromion with no strain during the upper trapezius muscle taping. The neck was laterally flexed to the opposite side, and rotated to the same side while taping with a tension of 15–25% and the end of the tape was attached to the muscle origin at the level of the 7th cervical spinous process without stretching. Finally, taping for levator scapulae started from the superior scapular angle. The shoulder was depressed, and the neck was laterally flexed and rotated to the opposite side during application. The end of the tape was attached to the muscle origin at the level of the transverse process of the first to fourth cervical vertebrae without stretching [21]. For the ST group, a placebo taping method that was considered to be ineffective (not from insertion to origin points of a muscle), with the same material without tension and with the neck in a neutral position, was employed. Banding application was performed for both groups once a week until four weeks. Tinnitus- VAS, Tinnitus Handicap Inventory (THI), cervical-VAS, and neck disability index scores were evaluated in all the subjects by the same investigator who was blinded to the treatment allocation.

2. Materials and methods 2.1. Study design The study was designed as a single centered, prospective, random­ ized, sham-controlled, and double-blinded trial. The study was approved by the Ethics Committee of the Hitit University Faculty of Medicine (approval number: 2018–12), registered in the clinical trials database (the registration number is NCT03782220) and performed according to the Declaration of Helsinki. The participants were fully informed about the procedures, and written consent was obtained. 2.2. Participants and assessments Patients complaining of tinnitus first underwent otologic and audi­ ological evaluation by an otolaryngologist. Tinnitus characteristics, including severity, localization (unilateral/bilateral), type (pulsatile/ non-pulsatile), symptom duration, and the frequency (number of days with symptoms) were recorded. Patients diagnosed with somatosensory tinnitus and concomitant neck complaints [cervical pain-visual analog scale (cervical pain-VAS) > 2] for at least six weeks were referred to a physical medicine and rehabilitation outpatient clinic. Of these patients, those having objective tinnitus, subjective tinnitus with hearing loss, or Meniere’s disease, vertigo, middle-ear pathologies, intracranial pathol­ ogies, whiplash injury, previous cervical spinal surgery, pregnancy, infection, malignancy, or those who received cervical physical rehabil­ itation program in the past three months were excluded. The demographics of all participants, including age, gender, and body mass index, were recorded, and physical examinations [cervical joint range of motion (cervical- ROM), cervical manual muscle testing (cervical- MMT) and myofascial trigger points for SCM, upper trapezius and levator scapulae muscles] were performed by a single investigator. The active ROM of the cervical joint (flexion, extension, left and right rotation, left and right lateral flexion) was measured using a goniometer while the patients were seated with their arms relaxed and resting on their thighs in a neutral position. The reliability of the active cervicalROM measurement is good [18]. The strength of the cervical muscles (cervical flexor, extensor, right and left lateral flexor and rotator mus­ cles) was measured using MMT. According to the MMT, the strength was rated in six grades: 0 (“none” or no visible or palpable contraction), 1 (“trace” or visible or palpable contraction with no motion), 2 (“poor” or full ROM gravity eliminated), 3 (“fair” or full ROM against gravity), 4 (“good” or full ROM against gravity with moderate resistance), 5 (“normal” or full ROM against gravity with maximum resistance) [19]. The trigger point diagnostic criteria included: (1) palpable taut bands present in the skeletal muscles, (2) hypersensitive spots present in the taut bands, (3) palpable or visible local twitch on snapping palpation, and (4) referred pain triggered on palpation of a sensitive spot. The test was considered positive when at least one active trigger point was found [20]. Trigger points for the muscles of the SCM, upper trapezius, and levator scapulae were evaluated before treatment. Additionally, during the measurement of cervical- ROM, cervical- MMT and trigger point palpation changes in tinnitus were recorded to investigate the provo­ cation of tinnitus arising as a result of neck movements. 2.3. Interventions After baseline measurements, the participants were randomly assigned to a KT group and a sham taping (ST) group using a computer program that included a randomized table of numbers, which was created by an independent individual who was not involved in the recruitment and treatment of patients. Numbered cards with a random

Fig. 1. The application of kinesio tape to sternocleidomastoid, upper trapezius, and levator scapulae muscles. 2

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2.4. Tinnitus severity (tinnitus- VAS)

3. Results

The visual analog scale was used for measuring the tinnitus severity. VAS measurements are valid and reliable measurements for capturing reductions in tinnitus severity in patients with subjective tinnitus [22]. The patients were instructed to mark on a scale of 0–10, what best described their current severity of tinnitus, where 0 corresponds to “no tinnitus” and 10 corresponds to “extremely loud tinnitus”. Tinnitus severity was performed at the baseline and the end of the treatment visit (at 4th week).

The Consolidated Standards of Reporting Trials (CONSORT) diagram of the participants is shown in Fig. 2. Fifty-nine patients with tinnitus were assessed for eligibility; however, only 37 of them were recruited. Among the 37 patients, seven patients did not complete the follow-up because of lack of time, transportation problems, or other health is­ sues. In total, data from 30 patients were analyzed who were random­ ized into either the KT group (n ¼ 15; age: 44.67 � 11.26) or the sham taping (ST) group (n ¼ 15; age: 49.80 � 11.04). The demographic data and clinical features of the groups who completed the intervention are presented in Table 1. There were no significant differences in gender, age, body mass index and duration of disease among the participants of the study groups. Tinnitus localization (unilateral/bilateral) (P ¼ 0.065), type (pulsatile/non-pulsatile) (0.456), symptom duration (months) (P ¼ 0.325), symptom frequency (days/week) (P ¼ 0.593), cervical- ROM (P ¼ 0.195), cervical- MMT (P ¼ 0.543), myofascial trigger points (P ¼ 0.409) and tinnitus provocation (P ¼ 0.456) did not show any significant difference between the study groups. The taping sessions were well tolerated, and no adverse events occurred. No significant differences in outcome measures, tinnitus-VAS, THI, cervical pain-VAS, and NDI scores, were found at baseline (all P > 0.05) between the groups. Tinnitus-VAS, THI, cervical pain-VAS, and NDI improved significantly in the KT group after the intervention (all P � 0.001). In the control group, no significant differences in the outcome measures were found at the 4th week compared to the baseline (P ¼ 0.108, P ¼ 0.282, P ¼ 0.120 and P ¼ 1.000, respectively) (Table 2, Fig. 3, Fig. 4).

2.5. Tinnitus Handicap Inventory (THI) The questionnaire was comprised of 25 items with a functional subscale (11 items), emotional subscale (9 items), and catastrophic subscale (5 items). Each question was rated as 0 (not affected), 2 (sometimes affected), or 4 (always affected). The total score ranged from 0 to 100, with higher scores indicating higher levels of perceived tinnitus handicap. The Turkish-version of THI was reported to be valid and reliable [23]. This assessment was performed at the baseline and the end of treatment visit (at 4th week). 2.6. Cervical pain (cervical pain-VAS) Pain intensity was measured with VAS, which was used to measure musculoskeletal pain with very good reliability and validity [24]. The patients were instructed to mark on a scale of 0–10, what best described their current neck pain, where 0 corresponded to “no pain” and 10 corresponded to “severe pain”. Cervical pain-VAS was performed at the baseline and the end of the treatment visit (at 4th week).

4. Discussion

2.7. Neck disability index (NDI)

This study, to the best of the authors’ knowledge, is the first trial ever, carried out to evaluate the efficacy of KT in participants with so­ matosensory tinnitus associated with neck complaints. The results of this randomized controlled trial demonstrate that KT applied to the SCM, upper trapezius, and levator scapulae muscles for four weeks is effective in treating somatosensory tinnitus associated with neck complaints compared to sham taping. These results are promising, as tinnitus is known to be an untreatable symptom that adversely affects patients’ daily activities and overall quality of life. Somatosensory tinnitus, a specific subgroup of subjective tinnitus, is completely underdiagnosed due to a lack of relevant research [6]. Somatosensory tinnitus with neck complaints is defined as “cervi­ cogenic somatic tinnitus” in the literature, and there have been many studies on its treatment [13]. Sanchez et al. stated that “cervicogenic somatic tinnitus” must be suspected whenever a patient has a history of head or neck trauma; tinnitus associated with some manipulation of the teeth, jaw, or cervical spine; recurrent episodes of head, neck, or shoulder girdle pain; temporal coincidence of the appearance of or in­ crease in both pain and tinnitus; increased tinnitus during inadequate posture when resting, walking, working, or sleeping; and periods of intense bruxism during the day or night [6]. It is clear that these patients should be referred for musculoskeletal evaluation by a physiatrist after evaluation by an otolaryngologist [26]. Recently, Michiels et al. designed a study on the diagnostic criteria for somatosensory tinnitus using an international Delphi survey and consensus meetings. These criteria include items relating to somato­ sensory modulation and specific tinnitus characteristics and symptoms that may accompany tinnitus. Criteria for tinnitus modulation include the patient’s ability to modulate tinnitus with voluntary movements of the head, neck, jaw, or eyes; somatic maneuvers; or pressure on myo­ fascial trigger points. Tinnitus characteristics include neck or jaw pain that appears and becomes aggravated simultaneously. Tinnitus is pre­ ceded by head or neck trauma and increases with bad posture. Tinnitus pitch varies with loudness and/or location. Finally, tinnitus is

The NDI has been designed to assess self-reported neck functional status. The questionnaire comprises 10 items related to pain, activities of daily living, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation, each rated on a 6-point Likert scale with the final score ranging from 0 (no disability) to 50 (major disability). Higher scores represent greater disability. NDI was found reliable and valid for neck disorders. Turkish version of the NDI was also reported to be valid and reliable [25]. This assessment was performed at baseline and the end of treatment visit (at 4th week). 2.8. Sample size The sample size estimation was performed using the G Power soft­ ware (v 3.1). It was determined that 15 individuals for each group must have been recruited to detect a difference at 5% type 1 error level with 95% power for the Cohen’s d value of 1.63 based on the minimum clinically important difference for VAS-loudness reported in the previ­ ous research [22]. 2.9. Statistical analysis All statistical analyses were performed using SPSS (Statistical Pack­ age for Social Sciences) version 21.0. Descriptive statistics were pre­ sented as the mean � standard deviation (SD). Categorical variables were presented as number (n) and percentage (%). Visual assessment (histogram, boxplot) and the Shapiro-Wilk test was used for normality evaluation. All continuous variables were observed to be normally distributed. A Chi-square test was used to compare the nominal data. An inde­ pendent samples t-test was used to compare continuous data of the two groups. A dependent t-test was used to compare the pre-and-post values of continuous data. Statistical significance was accepted for values of p < 0.05. 3

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Fig. 2. CONSORT flow diagram of study participants. Table 1 Demographic data and clinical features of the study groups.

Table 2 Outcome measurements for the study groups.

Variable

KT group

ST group

P valuea

Gender (male/female) Age, mean (�SD)

7/8 44.67 � 11.26 27.46 � 3.50 9/6 5/10 11.53 � 8.33

6/9 49.80 � 11.04 29.61 � 4.88 4/11 7/8 10.06 � 5.18

0.713 0.218

6.73 � 1.03

6.53 � 0.99

0.593

2 (13.3%) 1 (6.7%) 10 (66.7%)

5 (33.3%) 2 (13.3%) 12 (80.0%)

0.195 0.543 0.409

73%

60%

0.456

Body mass index, mean (�SD) Localization (unilateral/bilateral) Type (pulsatile/non-pulsatile) Symptom duration (months), mean (�SD) Symptom frequency (days/week), mean (�SD) Restricted cervical- ROM, n (%) Reduced cervical- MMT, n (%) Positive myofascial trigger points, n (%) Provacation of tinnitus, n (%)

Measure

TinnitusVAS Tinnitus handicap index Cervical pain-VAS Neck disability index

0.179 0.065 0.456 0.325

Pa value

KT group Mean (�SD) Baseline

at 4th week

7.47 � 1.24 65.73 � 10.84

5.07 � 1.33 52.67 � 13.02

<0.001

6.20 � 1.52 19.53 � 6.62

3.67 � 1.75 12.80 � 5.08

<0.001

0.001

<0.001

Pa value

ST group Mean (�SD) Baseline

at 4th week

7.13 � 2.26 61.06 � 17.72

6.58 � 1.88 59.33 � 17.80

0.108

6.67 � 1.44 23.47 � 5.33

6.13 � 1.68 23.47 � 5.46

0.120

0.282

1.000

KT group: Kinesio taping group, ST group: Sham taping group, Tinnitus- VAS: Tinnitus visual analog scale, Cervical pain- VAS: Cervical pain visual analog scale, SD: Standard deviation. a : Paired t-test was used.

KT group: Kinesio taping group, ST group: Sham taping group, cervical- ROM: cervical joint range of motion, cervical- MMT: cervical manual muscle testing, SD: Standard deviation. a : Chi-square test and independent samples t-test were used.

option. In recent years, indications for the application of this option have broadened, and clinical trials are continuously being undertaken. KT is an easy, quick, and safe method to treat patients, and therefore, physicians prefer to use it in clinical practice. KT works based on the principles of kinesiology, which uses the self-healing mechanisms of the body and affects the musculoskeletal, neurological, and vascular sys­ tems [29]. It can be considered that KT applied for cervicogenic somatic tinnitus has benefited from these principles. KT increases blood and lymph fluid circulation under the taped area by elevating the space between the skin and soft tissue, which may relieve pain by lifting trigger points and ROM limitation by affecting muscle functions [30]. Also, the tension provided by the tape can facilitate the inhibitory mechanism of pain (gate control theory) by reducing nociceptive

accompanied by frequent pain in the cervical spine, head, or shoulder girdle; the presence of pressure-tender myofascial trigger points; increased muscle tension in the suboccipital muscles; increased muscle tension in the extensor muscles of the cervical spine; temporomandib­ ular disorders; teeth clenching or bruxism; and dental diseases [27]. Although not all these criteria were used in the present study, nearly all items were evaluated during baseline assessments. In future studies, the selection of patients can be accomplished using these criteria, thus increasing the reliability of the results. Although there is no cure for somatosensory tinnitus, conservative physical therapy modalities are relatively successful [28]. KT is one such 4

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threshold, and cervical range of motion in patients with cervical myo­ fascial pain syndrome [35]. Another study showed that the KT of latent myofascial trigger points in the SCM muscle significantly decreased pain intensity and considerably increased range of motion of the temporo­ mandibular joint [36]. In a recent systematic review and meta-analysis by Zhang et al., statistical evidence indicates that KT can be recom­ mended to relieve pain and increase range of motion for patients with myofascial pain syndrome [37]. The results of the present study are concordant with the data re­ ported in the existing literature. The KT method applied to selected muscles resulted in significant improvement in neck pain, neck-related disability, and tinnitus-related disability compared to sham taping. Based on this study, KT is thought to be effective in treating tinnitus loudness and disability in individuals with somatosensory tinnitus associated with neck complaints. Therefore, there is a need to develop and implement algorithms for diagnosing and treating individuals with somatosensory tinnitus associated with neck pain and a strict definition of the role of physiatrists. Researches for the effect of KT may show different results. PuermaCastillo et al. [17] investigated the effect of KT in patients with neck pain. They found no evidence of additional benefits from the use of KT in patients with neck pain, whereas a protocol of manual therapy and physical exercises significantly improved pain and mobility in this population. The limitations of this study are the small sample size and the short follow-up time. Another limitation is that only patients whose tinnitus was modulated by neck maneuvers were included. Several authors have proposed different temporomandibular joint and neck maneuvers to modulate tinnitus loudness and pitch. Studies with larger samples of patients with somatosensory tinnitus that assess the long-term effects of KT are recommended. In addition, a detailed investigation of modula­ tion maneuvers and patient selection using new diagnostic criteria for somatosensory tinnitus [27] may provide more reliable results.

Fig. 3. The changes in the outcome measures over time for the Kinesio taping group. KT group: Kinesio taping group, Tinnitus- VAS: Tinnitus visual analog scale, Cervical- VAS: Cervical visual analog scale.

5. Conclusion Application of KT to the sternocleidomastoid, upper trapezius, and levator scapulae muscles are more effective than sham taping in improving tinnitus severity, tinnitus handicap, neck pain and disability due to cervicogenic somatic tinnitus. Clinical trial registration number The study was registered at the US National Institutes of Health (ClinicalTrials.gov) (NCT03782220) and available at https://clinicaltria ls.gov/ct2/show/NCT03782220?term¼tu%C4%9Fbaþatan&rank¼2. Funding No funding sources received for this work. Declaration of competing interest The authors have no conflict of interests.

Fig. 4. The changes in the outcome measures over time for the sham taping group. ST group: Sham taping group, Tinnitus- VAS: Tinnitus visual analog scale, Cervical- VAS: Cervical visual analog scale.

CRediT authorship contribution statement �ba Atan: Conceptualization, Methodology, Software, Formal Tug �an Atan: Method­ analysis, Investigation, Writing - original draft. Dog ology, Validation, Formal analysis, Investigation, Resources, Visualiza­ € tion, Investigation, Software, Writing - review & editing. Sumru Ozel: Resources, Supervision, Writing - review & editing.

afferent inputs in the central nervous system [31]. In recent years, the effect of KT on fascial tissue has gained great importance. KT application can realign fascial tissue function by normalizing muscle tension [32, 33]. �pez et al. [34] KT treatment In a randomized clinical trial by Espí-Lo was found effective in reducing pain and improving neck and shoulder comfort, trunk posture and quality of life in people with fibromyalgia syndrome. Ay et al. showed that KT improved pain, the pressure-pain

Acknowledgments The authors would like to thank all the participants of this study, and 5

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Ilkay Kocak for providing envelopes for the randomization.

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