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Management of symptoms of Restless Legs Syndrome with use of a traction straight leg raise: A preliminary case series
Manual Therapy 18 (2013) 299e302
Contents lists available at SciVerse ScienceDirect
Manual Therapy journal homepage: www.elsevier.com/math
Original article
Management of symptoms of Restless Legs Syndrome with use of a traction straight leg raise: A preliminary case series Eric M. Dinkins a, *, Jennifer Stevens-Lapsley b a b
Select Physical Therapy, 814 S. Perry St. Unit D, Castle Rock, CO 80104, USA University of Colorado, Physical Therapy Program, Denver, CO, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 September 2011 Received in revised form 27 October 2012 Accepted 5 November 2012
Restless Legs Syndrome (RLS) is estimated to affect 5e15 percent of the U.S. population. There are few studies investigating non-pharmacological treatments for RLS, such as physical therapy and/or peripheral neural mobilization. The traction straight leg raise (tSLR) technique is one such mobilization that may affect central and peripheral neural pathways and reduce RLS symptoms. The purpose of this study is to determine the effects of a tSLR on the symptoms associated with RLS. A cohort of fifteen people was enrolled. Thirteen subjects (11 female) between the ages of 32e64 completed the study. Subjects completed two questionnaires to quantify their severity of RLS before treatment was initiated and at the final session. These measures included: the Restless Legs Syndrome Rating Scale (RLSRS) 0e40, an RLS Ordinal Scale, and a Global Rating of Change (GROC) assessments (7, 0, þ7). Patients were treated with tSLR bilaterally for four total visits on days 1, 3, 8, and 15. Results indicated an RLSRS pre-treatment average of 24.8 (severe) and post-treatment average of 9.2 (mild), representing a 63% improvement from baseline (p < 0.05). Ten of 13 subjects reported a GROC of þ4 or higher at the final session, indicating at least a moderate improvement in patient status from baseline. Our results indicate that following a series of tSLR treatments symptoms were reduced in individuals with idiopathic RLS. A prospective, randomized controlled trial is necessary to evaluate the potential for a tSLR to effectively manage idiopathic RLS symptoms. Ó 2012 Elsevier Ltd. All rights reserved.
Keywords: Restless Legs Syndrome Restless Legs Syndrome Rating Scale Idiopathic Traction straight leg raise
1. Introduction Restless Legs Syndrome (RLS) affects 5e15 percent of the U.S. population. Both men and women are affected with women representing the majority of cases. The syndrome may begin at any age, even in infants and young children. However, most people who are severely affected are middle-aged or older (Phillips et al., 2000; Zucconi and Ferini-Strambi, 2004). The severity of RLS symptoms ranges from mild to intolerable. Symptoms such as tightness in the legs, an uncontrollable urge to move the legs, creeping, crawling, pulling, itching, aching and/or pain get gradually worse over time in about two-thirds of people with the condition. Symptoms are generally worse in the evening and night and are accompanied by an urgency to move to relieve the condition (Berger et al., 2004). While symptoms are usually quite mild in young adults, by age 50, the symptoms cause severe nightly sleep disruption that may
* Corresponding author. Tel.: þ1 720 352 1776; fax: þ1 303 814 2865. E-mail addresses: [email protected], [email protected] (E.M. Dinkins). 1356-689X/$ e see front matter Ó 2012 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.math.2012.11.002
lead to decreased alertness in the daytime, general fatigue and mood disturbance. In many people, the condition is not diagnosed until 10e20 years after symptoms begin (Phillips et al., 2000; Ohayon and Roth, 2002; Abetz et al., 2004; Berger and Kurth, 2007). The exact etiology of RLS is unknown. However, it is widely accepted that RLS symptoms are predominantly the result of an alteration, restriction or irritation of the normal function of the nervous system (Phillips et al., 2000; Lee, 2001; Abetz et al., 2004; Manconi et al., 2004; Berger and Kurth, 2007). Once correctly diagnosed, RLS is commonly treated with the use of pharmaceutical agents. Some drugs can have severe side effects including nausea, dizziness, hallucinations, orthostatic hypotension, sudden sleep attacks during the daytime, hypersexuality and compulsive gambling (Bostwick et al., 2009). To date, there has been limited research on non-pharmaceutical management strategies for symptoms of RLS (Mitchell, 2011), especially in the form of physical therapy (Aukerman et al., 2006). The traction straight leg raise (tSLR) technique is one such form of physical therapy that may affect or reduce RLS symptoms. The tSLR technique has been previously used to improve straight leg raise hip flexion range of motion in normal subjects as well as those with
300
E.M. Dinkins, J. Stevens-Lapsley / Manual Therapy 18 (2013) 299e302
lower back pain. The mechanism for such improvements is thought to involve alterations of the typical stretch reflex at the posterior leg and improve nerve mobility in the lower extremity (Hall, 2001, 2006). It is the author’s hypothesis that the increased hip range of motion achieved during a tSLR may also provide neural mobilization to the posterior element in the lower extremity without promoting stress or tension to these structures. This hypothesis, along with clinical and anecdotal experience on RLS symptoms by the lead author in an outpatient orthopedic setting, lead to the tSLR as the chosen intervention. The purpose of this study was to investigate the preliminary changes in symptoms of RLS using a tSLR technique as described by Mulligan (1999). 2. Methods 2.1. Participants Subjects were recruited via local flyers and newspaper advertisements seeking volunteers for the study. The study was conducted using a pre-test, intervention, post-test design. Inclusion criteria included: a diagnosis of Restless Legs Syndrome (RLS) by a board certified physician, subject unfamiliarity with the technique of tSLR, and English language skills. Exclusion criteria for the study included: diagnosed secondary or primary progressive neurological disorders (e.g. peripheral neuropathy, diabetic neuropathy, Parkinson’s disease, Amyotrophic lateral sclerosis, etc), history of spinal cord injury, individuals involved in a worker’s compensation case, low back pain that was affected by straight leg raise (SLR) or hamstring stretching, vulnerable populations (e.g. decisionally challenged, prisoners, etc), pregnant women, and hip, knee, or ankle pathology requiring surgical intervention in the previous 12 months. Subjects taking prescribed medication for RLS were not excluded from the study. However, initiating medication use designed for controlling the symptoms of RLS after beginning the study was prohibited. Subjects completed two questionnaires to quantify their severity of RLS before treatment was initiated and at the final session: the Restless Legs Syndrome Rating Scale (RLSRS) 0e40, and an RLS Ordinal scale 0e8 (Walters et al., 2003). Subjects were blinded to the results and category of the RLSRS completed prior to each treatment session. The Global Rating of Change (GROC) form was also completed at the final session. The GROC quantifies a subject’s response on a scale of 7 (a very great deal worse), 0 (no change), þ7 (a very great deal better). The physical therapist performing the treatment was blinded to the results of each selfassessment measure. 2.2. Procedures Subjects first completed the above stated clinical assessment measures prior to any intervention. Treatment was initiated by placing subjects in a quiet room lying in supine for 5 min. Measurements for heart rate and blood pressure were taken to ensure vitals were within a normal range (Pennestri et al., 2007; Siddiqui, 2007; Winkleman, 2008). After these measurements were taken, each subject performed a five minute warm-up, walking on a treadmill. The speed was determined by the subject to simulate normal walking speed. The subject was then instructed to lie supine with arms either at his/her sides or resting on his/her stomach with the head rested on a single pillow. A mobilization belt was placed at the mid-thigh of the contra-lateral leg during the tSLR intervention in attempt to isolate the movement at the ipsi-lateral leg (Fig. 1). The subject was provided a verbal explanation of the tSLR technique and instructed to maintain full relaxation of the lower limb during the technique. The subject was instructed to notify the
Fig. 1. Mulligan traction straight leg raise technique.
investigator to the onset of stretch or discomfort in the posterior leg and was then returned to resting position. The treatment was performed by a licensed physical therapist who was also a Certified Mulligan Practitioner and had received extensive training in the tSLR technique. Three sets of three repetitions of the tSLR were performed on each subject during each treatment session. A period of 1e2 min was allowed between each tSLR set performed. At the final repetition of the third set, the subject was instructed to perform a brief, active, tolerable dorsiflexion action at the ankle after a stretch or tension was reported in the lower extremity from the tSLR. This was done with intent to maximize neural mobility of the posterior elements of the peripheral nervous system in the lower extremity. The leg was then returned to the starting position. The belt was switched to the opposite side and the intervention was performed bilaterally. No home exercise program was given. Subjects were asked to maintain their current lifestyle and not to change diet, exercise or medication use during the study. Treatment was performed on days 1, 3, 8 and 15. Subjects returned on day 22 to complete the clinical assessment measures. 2.3. Data analysis A paired t test was used to compare the difference between pretreatment and post-treatment outcomes for the continuous variable RLSRS; a Wilcoxon signed rank test was used to compare the difference between pre-treatment and post-treatment outcomes for the RLS Ordinal Scale results because the range of the ordinal scale is 1e10, and the sample is small. Continuous data are reported as mean SD while ordinal and categorical data are presented as median (25th percentile, 75th percentile) and Interquartile range (IQR). The alpha level for statistical significance was designated a priori as .05. Statistical analysis was performed using SAS 9.2. 3. Results Fifteen subjects were enrolled and thirteen subjects (11 female) between the ages of 33e64 (mean SD: 46.6 9.23) completed the study. A summary of subject demographics and baseline data can be found in Table 2. None of the subjects were smokers. The tSLR technique resulted in a 63% improvement in RLS symptoms in this cohort (RLSRS) (median difference ¼ 3; p25 ¼ 2, p75 ¼ 4; IQR ¼ 2; p < 0.001). The RLSRS improved from pre-treatment (mean SD) [24.8 6.1 (severe)] to post-treatment [9.2 6.5
E.M. Dinkins, J. Stevens-Lapsley / Manual Therapy 18 (2013) 299e302
Represents Single Subject Data Represents Two Subject Data
8
Self Perceived Severity Scale
(mild)] (Fig. 2). Similar improvements were demonstrated for the RLS ordinal scale (mean difference ¼ 3.2; CI ¼ 2.1, 4.2; p < 0.001) (Fig. 3). Individual results of the GROC can be found on Table 1, and ranged from þ1 (a tiny bit better/almost the same) to þ7 (a very great deal better). The median (p25, p75) response for the GROC (Table 1) was 4 (4,7) with an IQR of 3. It has been reported that scores of þ4 and þ5 are indicative of moderate changes in patientperceived status (Jaeschke et al., 1989). In the present study, 10 patients (76.9% of total) reported at least a þ4 improvement in symptoms. No subject reported symptoms that worsened from baseline with this treatment.
301
7 6 5 4 3 2 1 0 Pre-Treatment
4. Discussion The exact etiology of primary RLS has been widely investigated and appears to differ between individuals. It is universally accepted that whatever the cause for a specific individual’s symptom presentation, it is a neurological condition that manifests primarily in the legs. Some common hypotheses for mechanisms explaining RLS include changes in dopamine levels, iron deficiency, and poor nutrition (Urban, 1981; Phillips et al., 2000; Ohayon and Roth, 2002; Abetz et al., 2004; Zucconi and Ferini-Strambi, 2004). However, little consideration has been given to the treatment of the peripheral nervous system to manage idiopathic RLS symptoms. Our results indicate that following a series of tSLR treatments, symptoms reduced in individuals in this cohort study by a mean of 63% with a primary diagnosis of idiopathic RLS. This is encouraging for the development of programs to address the symptoms of idiopathic RLS with physical therapy techniques. Both the RLSRS and the RLS Ordinal scale outcomes resulted in similar patterns of improvement from baseline. This improvement suggests both clinical and quality of life improvements for the subjects in this study, as lower scores on both the RLSRS and RLS Ordinal scale have been validated to be linked to less intense RLS symptoms and life disturbance (Walters et al., 2003; Abetz et al., 2006). While the overall results of the tSLR treatment demonstrated a 63% improvement in symptoms, three subjects (3, 6, 10) reported complete resolution of their symptoms before the end of the study compared to their pre-treatment score. Conversely, one subject (7) reported no change in her symptoms compared to baseline. The nature of these improvements might be partially explained by a hypothesis formulated by previous authors regarding the systems that are affected during the tSLR technique. Hall (2001) reported superior improvement in SLR range of motion compared to other mobilization techniques by using the tSLR technique. He speculated that traction of the limb, during SLR, may trigger various reflex pathways in the central nervous system, affecting lumbar and lower extremity mechanoreceptors. Further inhibition may be
Post-Treatment
Fig. 3. Restless Legs Syndrome ordinal scale individual data: mild (1e2), moderate (3e 4), severe (5e6), very severe (7e8).
achieved from various descending supraspinal pathways causing alterations to the stretch reflex of the hamstrings and lumbar paravertebrals. This may account for the dramatic improvement seen in both increased hip range of motion and perceived stretch response by patients. It is our hypothesis that the increased hip range of motion achieved during a tSLR may also provide neural mobilization to the posterior element in the lower extremity without promoting stress or tension to these structures (Farhni, 1966; Grieve, 1970; Hanten and Chandler, 1994; Shacklock et al., 1994). These changes may be a contributing factor to the improvement of RLS symptoms in this case series. However, the exact mechanism of how a tSLR might alter symptoms associated with RLS is unknown at this time. In this study, there was no clear indication of what patient factors were correlated to an improvement in RLS symptoms. Subjects 1, 4, 8 and 10 were taking Ropinirole, a dopamine agonist prescribed for RLS at the onset of treatment and subject 2 was taking Oxycodone, an opioid commonly used as a second option for management of RLS symptoms. All continued taking their prescribed medication throughout duration the treatment (Table 2). There were moderate improvements in symptoms for subjects taking medication, as well as those not taking medication to manage their RLS symptoms at the time of the study. Therefore, it remains unclear whether medications for RLS had an effect on the outcomes in this cohort. There are limitations to this investigation that should be acknowledged. One clear limitation of this study was the absence of a control group or randomization. As this study involved a technique that is not well known (Konstantinou et al., 2002) and has not been previously identified as a viable option for the management of RLS symptoms, it was determined that all subjects would receive the tSLR using baseline measures to assess changes in symptoms. However, the preepost study design used cannot link the
40 Table 1 Global rating of change.
35
Severity Score
30 25 20 15 10 5 0 Pre-Treatment
Post-Treatment
Fig. 2. RLSRS individual data. Scoring criteria: mild (1e10), moderate (11e20), severe (21e30), very severe (31e40).
Subject
GROC response
Associated score
1 2 3 4 5 6 7 8 9 10 11 12 13 Median (p25, p75)
Somewhat better Moderately better A very great deal better Quite a bit better Moderately better A very great deal better A tiny bit better Moderately better Moderately better A very great deal better A very great deal better A very great deal better A little bit better
3 4 7 5 4 7 1 4 4 7 7 7 2 4 (4, 7)
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Table 2 Demographics and baseline subject characteristics. Subject Age Gender Duration of Medication Dose/day Pre Pre ordinal (yrs) symptoms RLSRS scale (yrs) 1 2 3 4 5 6 7 8 9 10 11 12 13
64 63 33 47 41 47 38 39 64 37 51 41 39
F M F F F F F M M F F M F
10þ 0e5 5e10 5e10 10þ 10þ 10þ 10þ 10þ 10þ 10þ 10þ 5e10
Ropinirole Oxycodone N/A Ropinirole N/A N/A N/A Ropinirole N/A Ropinirole N/A N/A N/A
.75 mg 5 mg .5 mg
.5 mg .5 mg
17 27 20 31 18 28 23 26 22 35 35 20 20
4 5 2 6 4 6 6 6 6 7 7 4 4
treatment and the outcome directly. A different study design is necessary to demonstrate of the efficacy of this treatment. Another limitation was the limited duration of follow-up. This initial study was designed to determine only the short-term changes of RLS symptoms using the tSLR.
5. Conclusion Our results indicate that symptoms reduced following a series of tSLR treatments in individuals with a primary diagnosis of idiopathic RLS. This initial cohort study suggests there is a need for further research for management of RLS symptoms utilizing physical therapy techniques. A prospective, randomized controlled trial including use of neurodynamic testing to determine potential peripheral nerve irritation is necessary to better evaluate the potential for a tSLR to effectively manage idiopathic RLS symptoms and better evaluate the sustainability of these improvements over time. References Abetz L, Allen R, Follet A, Washburn T, Earley C, Kirsch J, et al. Evaluating the quality of life in patients with restless legs syndrome. Clin Ther 2004;26:925e32. Abetz L, Arbuckle R, Allen RP, Barcia-Borreguero D, Hening W, Walters AS, et al. The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting. Sleep Med 2006 Jun;7(4):340e9.
Aukerman MM, Aukerman D, Bayard M, Tudiver F, Thorp L, Bailey B. Exercise and restless legs syndrome: a randomized controlled trial. J Am Board Fam Med 2006;19:487e93. Berger K, Luedemann J, Trenkwalder C, John U, Kessler C. Sex and the risk of restless legs syndrome in the general population. Arch Intern Med 2004 Jan 26;164(2): 196e202. Berger K, Kurth T. RLS epidemiologyefrequencies, risk factors and methods in population studies. Mov Disord 2007;22(Suppl. 18):S420e3. Bostwick JM, Hecksel KA, Stevens SR, Bower JH, Ahlskog JE. Frequency of new-onset pathologic compulsive gambling or hypersexuality after drug treatment of idiopathic Parkinson disease. Mayo Clinic Proc 2009;84(4):310e6. Farhni WH. Observations on straight leg raise with special reference to nerve root adhesions. Can J Surg 1966;9:44e8. Grieve GP. Sciatica and the straight leg raising test in manipulative treatment. Physiotherapy 1970;56:337e46. Hall TM. Effects of the Mulligan traction straight leg raise technique on range of movement. J Man Manip Ther 2001;9(3):128e33. Hall TM. Mulligan traction straight leg raise: a pilot study to investigate effects on range of motion in patients with low back pain. J Man Manip Ther 2006;14(2): 95e100. Hanten WP, Chandler S. Effects of myofascial release leg pull on sagital plane isometrics contract-relax technique on passive straight leg-raise angle. J Orthop Sports Phys Ther 1994;20:138e44. Jaeschke R, Singer J, Guyatt G. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trial 1989;10:407e15. Konstantinou K, Foster N, Rushton A, Baxter D. The use of reported effects of mobilization with movement techniques in low back pain management: a cross-sectional descriptive survey of physiotherapists in Britain. Man Ther 2002;7:206e14. Lee KA. Restless legs syndrome and sleep disturbance during pregnancy: the role of folate and iron. J Womens Health Gend Based Med 2001 May;10(4):335e41. Manconi M, Govoni V, De Vito A, Economou NT, Cesnik E, Casetta I, et al. Pregnancy as a risk factor for restless legs syndrome. Sleep Med 2004 May;5(3):305e8. Mitchell U. Nondrug-related aspects of treating Ekbom disease, formerly known as restless legs syndrome. Neuropsychiatr Dis Treat 2011:251e7. Mulligan BR. Manual therapy “NAGS”, “SNAGS”, and “MWM’s” etc. 4th ed. Wellington/New Zealand: Hutchinson, Bowman and Stewart; 1999. Ohayon MM, Roth T. Prevalence of restless legs syndrome and periodic limb movement in the general population. J Psychosom Res 2002;53:547e54. Pennestri MH, Montplaisir J, Colombo R, Lavigne G, Lanfranchi PA. Nocturnal blood pressure changes in patients with restless legs syndrome. Neurology 2007 Apr 10;68(15):1213e8. Phillips B, Young T, Finn L, Asher K, Hening WA, Purvis C. Epidemiology of restless legs syndrome in adults. Arch Intern Med 2000;160:2137e41. Shacklock MO, Butler DS, Slater H. Treatment of altered nervous system mechanics. In: Grieve’s modern manual therapy. 2nd ed.; 1994. p. 21e38. Siddiqui F. Rise of blood pressure with periodic limb movements in sleep and wakefulness. Clin Neurophysiol 2007 Sep;118(9):1923e30. Urban LM. The straight leg raise test: a review. J Orthop Sports Phys Ther 1981;2: 117e33. Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, et al. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med 2003;4:121e32. Winkleman JW. Association of restless legs syndrome and cardiovascular disease in the Sleep Heart Health Study. Neurology 2008 Jan 1;70(1):35e42. Zucconi M, Ferini-Strambi L. Epidemiology and clinical findings of restless legs syndrome. Sleep Med 2004 May;5(3):293e9.
Contents lists available at SciVerse ScienceDirect
Manual Therapy journal homepage: www.elsevier.com/math
Original article
Management of symptoms of Restless Legs Syndrome with use of a traction straight leg raise: A preliminary case series Eric M. Dinkins a, *, Jennifer Stevens-Lapsley b a b
Select Physical Therapy, 814 S. Perry St. Unit D, Castle Rock, CO 80104, USA University of Colorado, Physical Therapy Program, Denver, CO, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 September 2011 Received in revised form 27 October 2012 Accepted 5 November 2012
Restless Legs Syndrome (RLS) is estimated to affect 5e15 percent of the U.S. population. There are few studies investigating non-pharmacological treatments for RLS, such as physical therapy and/or peripheral neural mobilization. The traction straight leg raise (tSLR) technique is one such mobilization that may affect central and peripheral neural pathways and reduce RLS symptoms. The purpose of this study is to determine the effects of a tSLR on the symptoms associated with RLS. A cohort of fifteen people was enrolled. Thirteen subjects (11 female) between the ages of 32e64 completed the study. Subjects completed two questionnaires to quantify their severity of RLS before treatment was initiated and at the final session. These measures included: the Restless Legs Syndrome Rating Scale (RLSRS) 0e40, an RLS Ordinal Scale, and a Global Rating of Change (GROC) assessments (7, 0, þ7). Patients were treated with tSLR bilaterally for four total visits on days 1, 3, 8, and 15. Results indicated an RLSRS pre-treatment average of 24.8 (severe) and post-treatment average of 9.2 (mild), representing a 63% improvement from baseline (p < 0.05). Ten of 13 subjects reported a GROC of þ4 or higher at the final session, indicating at least a moderate improvement in patient status from baseline. Our results indicate that following a series of tSLR treatments symptoms were reduced in individuals with idiopathic RLS. A prospective, randomized controlled trial is necessary to evaluate the potential for a tSLR to effectively manage idiopathic RLS symptoms. Ó 2012 Elsevier Ltd. All rights reserved.
Keywords: Restless Legs Syndrome Restless Legs Syndrome Rating Scale Idiopathic Traction straight leg raise
1. Introduction Restless Legs Syndrome (RLS) affects 5e15 percent of the U.S. population. Both men and women are affected with women representing the majority of cases. The syndrome may begin at any age, even in infants and young children. However, most people who are severely affected are middle-aged or older (Phillips et al., 2000; Zucconi and Ferini-Strambi, 2004). The severity of RLS symptoms ranges from mild to intolerable. Symptoms such as tightness in the legs, an uncontrollable urge to move the legs, creeping, crawling, pulling, itching, aching and/or pain get gradually worse over time in about two-thirds of people with the condition. Symptoms are generally worse in the evening and night and are accompanied by an urgency to move to relieve the condition (Berger et al., 2004). While symptoms are usually quite mild in young adults, by age 50, the symptoms cause severe nightly sleep disruption that may
* Corresponding author. Tel.: þ1 720 352 1776; fax: þ1 303 814 2865. E-mail addresses: [email protected], [email protected] (E.M. Dinkins). 1356-689X/$ e see front matter Ó 2012 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.math.2012.11.002
lead to decreased alertness in the daytime, general fatigue and mood disturbance. In many people, the condition is not diagnosed until 10e20 years after symptoms begin (Phillips et al., 2000; Ohayon and Roth, 2002; Abetz et al., 2004; Berger and Kurth, 2007). The exact etiology of RLS is unknown. However, it is widely accepted that RLS symptoms are predominantly the result of an alteration, restriction or irritation of the normal function of the nervous system (Phillips et al., 2000; Lee, 2001; Abetz et al., 2004; Manconi et al., 2004; Berger and Kurth, 2007). Once correctly diagnosed, RLS is commonly treated with the use of pharmaceutical agents. Some drugs can have severe side effects including nausea, dizziness, hallucinations, orthostatic hypotension, sudden sleep attacks during the daytime, hypersexuality and compulsive gambling (Bostwick et al., 2009). To date, there has been limited research on non-pharmaceutical management strategies for symptoms of RLS (Mitchell, 2011), especially in the form of physical therapy (Aukerman et al., 2006). The traction straight leg raise (tSLR) technique is one such form of physical therapy that may affect or reduce RLS symptoms. The tSLR technique has been previously used to improve straight leg raise hip flexion range of motion in normal subjects as well as those with
300
E.M. Dinkins, J. Stevens-Lapsley / Manual Therapy 18 (2013) 299e302
lower back pain. The mechanism for such improvements is thought to involve alterations of the typical stretch reflex at the posterior leg and improve nerve mobility in the lower extremity (Hall, 2001, 2006). It is the author’s hypothesis that the increased hip range of motion achieved during a tSLR may also provide neural mobilization to the posterior element in the lower extremity without promoting stress or tension to these structures. This hypothesis, along with clinical and anecdotal experience on RLS symptoms by the lead author in an outpatient orthopedic setting, lead to the tSLR as the chosen intervention. The purpose of this study was to investigate the preliminary changes in symptoms of RLS using a tSLR technique as described by Mulligan (1999). 2. Methods 2.1. Participants Subjects were recruited via local flyers and newspaper advertisements seeking volunteers for the study. The study was conducted using a pre-test, intervention, post-test design. Inclusion criteria included: a diagnosis of Restless Legs Syndrome (RLS) by a board certified physician, subject unfamiliarity with the technique of tSLR, and English language skills. Exclusion criteria for the study included: diagnosed secondary or primary progressive neurological disorders (e.g. peripheral neuropathy, diabetic neuropathy, Parkinson’s disease, Amyotrophic lateral sclerosis, etc), history of spinal cord injury, individuals involved in a worker’s compensation case, low back pain that was affected by straight leg raise (SLR) or hamstring stretching, vulnerable populations (e.g. decisionally challenged, prisoners, etc), pregnant women, and hip, knee, or ankle pathology requiring surgical intervention in the previous 12 months. Subjects taking prescribed medication for RLS were not excluded from the study. However, initiating medication use designed for controlling the symptoms of RLS after beginning the study was prohibited. Subjects completed two questionnaires to quantify their severity of RLS before treatment was initiated and at the final session: the Restless Legs Syndrome Rating Scale (RLSRS) 0e40, and an RLS Ordinal scale 0e8 (Walters et al., 2003). Subjects were blinded to the results and category of the RLSRS completed prior to each treatment session. The Global Rating of Change (GROC) form was also completed at the final session. The GROC quantifies a subject’s response on a scale of 7 (a very great deal worse), 0 (no change), þ7 (a very great deal better). The physical therapist performing the treatment was blinded to the results of each selfassessment measure. 2.2. Procedures Subjects first completed the above stated clinical assessment measures prior to any intervention. Treatment was initiated by placing subjects in a quiet room lying in supine for 5 min. Measurements for heart rate and blood pressure were taken to ensure vitals were within a normal range (Pennestri et al., 2007; Siddiqui, 2007; Winkleman, 2008). After these measurements were taken, each subject performed a five minute warm-up, walking on a treadmill. The speed was determined by the subject to simulate normal walking speed. The subject was then instructed to lie supine with arms either at his/her sides or resting on his/her stomach with the head rested on a single pillow. A mobilization belt was placed at the mid-thigh of the contra-lateral leg during the tSLR intervention in attempt to isolate the movement at the ipsi-lateral leg (Fig. 1). The subject was provided a verbal explanation of the tSLR technique and instructed to maintain full relaxation of the lower limb during the technique. The subject was instructed to notify the
Fig. 1. Mulligan traction straight leg raise technique.
investigator to the onset of stretch or discomfort in the posterior leg and was then returned to resting position. The treatment was performed by a licensed physical therapist who was also a Certified Mulligan Practitioner and had received extensive training in the tSLR technique. Three sets of three repetitions of the tSLR were performed on each subject during each treatment session. A period of 1e2 min was allowed between each tSLR set performed. At the final repetition of the third set, the subject was instructed to perform a brief, active, tolerable dorsiflexion action at the ankle after a stretch or tension was reported in the lower extremity from the tSLR. This was done with intent to maximize neural mobility of the posterior elements of the peripheral nervous system in the lower extremity. The leg was then returned to the starting position. The belt was switched to the opposite side and the intervention was performed bilaterally. No home exercise program was given. Subjects were asked to maintain their current lifestyle and not to change diet, exercise or medication use during the study. Treatment was performed on days 1, 3, 8 and 15. Subjects returned on day 22 to complete the clinical assessment measures. 2.3. Data analysis A paired t test was used to compare the difference between pretreatment and post-treatment outcomes for the continuous variable RLSRS; a Wilcoxon signed rank test was used to compare the difference between pre-treatment and post-treatment outcomes for the RLS Ordinal Scale results because the range of the ordinal scale is 1e10, and the sample is small. Continuous data are reported as mean SD while ordinal and categorical data are presented as median (25th percentile, 75th percentile) and Interquartile range (IQR). The alpha level for statistical significance was designated a priori as .05. Statistical analysis was performed using SAS 9.2. 3. Results Fifteen subjects were enrolled and thirteen subjects (11 female) between the ages of 33e64 (mean SD: 46.6 9.23) completed the study. A summary of subject demographics and baseline data can be found in Table 2. None of the subjects were smokers. The tSLR technique resulted in a 63% improvement in RLS symptoms in this cohort (RLSRS) (median difference ¼ 3; p25 ¼ 2, p75 ¼ 4; IQR ¼ 2; p < 0.001). The RLSRS improved from pre-treatment (mean SD) [24.8 6.1 (severe)] to post-treatment [9.2 6.5
E.M. Dinkins, J. Stevens-Lapsley / Manual Therapy 18 (2013) 299e302
Represents Single Subject Data Represents Two Subject Data
8
Self Perceived Severity Scale
(mild)] (Fig. 2). Similar improvements were demonstrated for the RLS ordinal scale (mean difference ¼ 3.2; CI ¼ 2.1, 4.2; p < 0.001) (Fig. 3). Individual results of the GROC can be found on Table 1, and ranged from þ1 (a tiny bit better/almost the same) to þ7 (a very great deal better). The median (p25, p75) response for the GROC (Table 1) was 4 (4,7) with an IQR of 3. It has been reported that scores of þ4 and þ5 are indicative of moderate changes in patientperceived status (Jaeschke et al., 1989). In the present study, 10 patients (76.9% of total) reported at least a þ4 improvement in symptoms. No subject reported symptoms that worsened from baseline with this treatment.
301
7 6 5 4 3 2 1 0 Pre-Treatment
4. Discussion The exact etiology of primary RLS has been widely investigated and appears to differ between individuals. It is universally accepted that whatever the cause for a specific individual’s symptom presentation, it is a neurological condition that manifests primarily in the legs. Some common hypotheses for mechanisms explaining RLS include changes in dopamine levels, iron deficiency, and poor nutrition (Urban, 1981; Phillips et al., 2000; Ohayon and Roth, 2002; Abetz et al., 2004; Zucconi and Ferini-Strambi, 2004). However, little consideration has been given to the treatment of the peripheral nervous system to manage idiopathic RLS symptoms. Our results indicate that following a series of tSLR treatments, symptoms reduced in individuals in this cohort study by a mean of 63% with a primary diagnosis of idiopathic RLS. This is encouraging for the development of programs to address the symptoms of idiopathic RLS with physical therapy techniques. Both the RLSRS and the RLS Ordinal scale outcomes resulted in similar patterns of improvement from baseline. This improvement suggests both clinical and quality of life improvements for the subjects in this study, as lower scores on both the RLSRS and RLS Ordinal scale have been validated to be linked to less intense RLS symptoms and life disturbance (Walters et al., 2003; Abetz et al., 2006). While the overall results of the tSLR treatment demonstrated a 63% improvement in symptoms, three subjects (3, 6, 10) reported complete resolution of their symptoms before the end of the study compared to their pre-treatment score. Conversely, one subject (7) reported no change in her symptoms compared to baseline. The nature of these improvements might be partially explained by a hypothesis formulated by previous authors regarding the systems that are affected during the tSLR technique. Hall (2001) reported superior improvement in SLR range of motion compared to other mobilization techniques by using the tSLR technique. He speculated that traction of the limb, during SLR, may trigger various reflex pathways in the central nervous system, affecting lumbar and lower extremity mechanoreceptors. Further inhibition may be
Post-Treatment
Fig. 3. Restless Legs Syndrome ordinal scale individual data: mild (1e2), moderate (3e 4), severe (5e6), very severe (7e8).
achieved from various descending supraspinal pathways causing alterations to the stretch reflex of the hamstrings and lumbar paravertebrals. This may account for the dramatic improvement seen in both increased hip range of motion and perceived stretch response by patients. It is our hypothesis that the increased hip range of motion achieved during a tSLR may also provide neural mobilization to the posterior element in the lower extremity without promoting stress or tension to these structures (Farhni, 1966; Grieve, 1970; Hanten and Chandler, 1994; Shacklock et al., 1994). These changes may be a contributing factor to the improvement of RLS symptoms in this case series. However, the exact mechanism of how a tSLR might alter symptoms associated with RLS is unknown at this time. In this study, there was no clear indication of what patient factors were correlated to an improvement in RLS symptoms. Subjects 1, 4, 8 and 10 were taking Ropinirole, a dopamine agonist prescribed for RLS at the onset of treatment and subject 2 was taking Oxycodone, an opioid commonly used as a second option for management of RLS symptoms. All continued taking their prescribed medication throughout duration the treatment (Table 2). There were moderate improvements in symptoms for subjects taking medication, as well as those not taking medication to manage their RLS symptoms at the time of the study. Therefore, it remains unclear whether medications for RLS had an effect on the outcomes in this cohort. There are limitations to this investigation that should be acknowledged. One clear limitation of this study was the absence of a control group or randomization. As this study involved a technique that is not well known (Konstantinou et al., 2002) and has not been previously identified as a viable option for the management of RLS symptoms, it was determined that all subjects would receive the tSLR using baseline measures to assess changes in symptoms. However, the preepost study design used cannot link the
40 Table 1 Global rating of change.
35
Severity Score
30 25 20 15 10 5 0 Pre-Treatment
Post-Treatment
Fig. 2. RLSRS individual data. Scoring criteria: mild (1e10), moderate (11e20), severe (21e30), very severe (31e40).
Subject
GROC response
Associated score
1 2 3 4 5 6 7 8 9 10 11 12 13 Median (p25, p75)
Somewhat better Moderately better A very great deal better Quite a bit better Moderately better A very great deal better A tiny bit better Moderately better Moderately better A very great deal better A very great deal better A very great deal better A little bit better
3 4 7 5 4 7 1 4 4 7 7 7 2 4 (4, 7)
302
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Table 2 Demographics and baseline subject characteristics. Subject Age Gender Duration of Medication Dose/day Pre Pre ordinal (yrs) symptoms RLSRS scale (yrs) 1 2 3 4 5 6 7 8 9 10 11 12 13
64 63 33 47 41 47 38 39 64 37 51 41 39
F M F F F F F M M F F M F
10þ 0e5 5e10 5e10 10þ 10þ 10þ 10þ 10þ 10þ 10þ 10þ 5e10
Ropinirole Oxycodone N/A Ropinirole N/A N/A N/A Ropinirole N/A Ropinirole N/A N/A N/A
.75 mg 5 mg .5 mg
.5 mg .5 mg
17 27 20 31 18 28 23 26 22 35 35 20 20
4 5 2 6 4 6 6 6 6 7 7 4 4
treatment and the outcome directly. A different study design is necessary to demonstrate of the efficacy of this treatment. Another limitation was the limited duration of follow-up. This initial study was designed to determine only the short-term changes of RLS symptoms using the tSLR.
5. Conclusion Our results indicate that symptoms reduced following a series of tSLR treatments in individuals with a primary diagnosis of idiopathic RLS. This initial cohort study suggests there is a need for further research for management of RLS symptoms utilizing physical therapy techniques. A prospective, randomized controlled trial including use of neurodynamic testing to determine potential peripheral nerve irritation is necessary to better evaluate the potential for a tSLR to effectively manage idiopathic RLS symptoms and better evaluate the sustainability of these improvements over time. References Abetz L, Allen R, Follet A, Washburn T, Earley C, Kirsch J, et al. Evaluating the quality of life in patients with restless legs syndrome. Clin Ther 2004;26:925e32. Abetz L, Arbuckle R, Allen RP, Barcia-Borreguero D, Hening W, Walters AS, et al. The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting. Sleep Med 2006 Jun;7(4):340e9.
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