The Effectiveness of Radial Shockwave Therapy on Myofascial Pain Syndrome in Neck and Upper Back.

NCT05381987 | Completed DMC

• 1 other identifier: RAC# 2221047
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Myofascial pain syndrome (MPS) is a common, costly and often persistent musculoskeletal problem. Radial shockwave (RSW) is one of the most common treatment for MFS. However, a recent systematic review found very low-level evidence to support its short-term benefit, due to poor methodological qualities. The authors therefore recommended further large scale, good quality placebo-controlled trials (RCT) in this area. Further still, previous studies have not considered the experiences of patient regarding this intervention. Study Objectives: To determine the effectiveness of RSW compared to placebo for the treatment of patients with MPS in neck and upper back, and to establish the experiences of patients receiving the treatment. Research Questions: Is RSW therapy more effective at improving MPS compared to a placebo? What are the experiences of patients with MPS receiving this treatment? Methods: A pragmatic double blind RCT to investigate the effectiveness of RSW on patients with MPS and a semi-structured-interview to investigate the patients' experience of receiving the treatment. Sample: 120 potential participants with MPS for the RCT and 20 participants for the semi-structured qualitative interview. Interventions: The Intervention group will receive a total of 6 sessions of RSW following manufacturer's parameters: 1.5 bar, pulses 2000, frequency 15 Hz (Time 3 minutes). The Control group will receive an identical treatment except that the they will receive a no energy shock of 0.3 bar, frequency 15 and no pulses. Outcome measures: Improvements in the patient's numeric pain scale (NPS), neck disability index (NDI), pressure pain threshold (PPT) and SF-12 questionnaires at 4, 8 and 12 weeks' follow-up between the two groups. Significance of the Study's Outcome: The expectation is that this study will add to the body of knowledge required to help patients, healthcare practitioners, policy makers and researchers make effective treatment choices on RSW in the management MFS.

Conditions

Myofascial Pain Syndrome of Neck

Keywords

Myofascial pain syndrome, trigger point pain, shockwave, randomised controlled trial

Outcome Measures

Primary Outcomes (4)

• Numeric pain rating scale (NPRS)

  NPRS is a single 11-point numeric scale (with 0 as "no pain" and 10 as the "worse imaginable pain") to measure pain intensity in adults (Hawker 2011). It allows patients to measure their level of pain accordingly using a whole number (0-10 integers) that corresponds to their pain intensity (Rodriguez, 2001). The scale is considered reliable (accurate and consistent), responsive (ability to detect clinically significant changes) and valid (actually measures what it sets out to) (Hawker, 2011). Accordingly, a pain reduction of 2 points, or 30%, on the NPRS scores is defined as Minimal Clinically Important Difference (MCID) \[Childs et al, 2005; Farrar et al, 2001\]. The NPS is relatively easy to comprehend, and to apply, especially by patients with musculoskeletal disorders (Hawker, 2011).

  12 weeks

• Neck Disability Index (NDI)

  It is the most commonly used self-rated disability score for assessing patients with neck pain Vernon \& Mior (1991). It consists of ten domains: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All sections are then totalled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. The score can also be reported as a percentage (0-100%). The Minimum Detectable Change (90% confidence) is 5 points or 10% points Vernon \& Mior (1991), and the MCID is in the range of 3.5-5.0 points (Pool et al, 2007).

  12 weeks

• Pressure pain threshold (PPT)

  It will be measured using a digital algometer and pain score measurement will be performed with digital palpation. The algometer circular flat tip with 1.0 cm2 surface will be slowly pushed vertically to the skin over the trigger points until the participants interprets the compression on skin as pain sensation. The exerted pressure will be enlarged at a rate of 1 kg/cm2. Participants will be requested to inform the treating physiotherapist by saying "yes" when the pain is perceived. The measurements will be taken three times with 40 seconds intervals, and the mean average value will be taken (Fischer, 1998). A mean difference of 0.94 kg/cm2 in PPT was defined as MCID (Asiri et al, 2020).

  12 weeks

• SF12 - Quality of life (QoL)

  Quality of life status will be evaluated using the short form (SF12), which is a shorter version of SF-36 questionnaire. The health survey (SF-12) questionnaire, consists of 12 items regarding the quality of life with respect to the physical and emotional aspects. Likert scales and yes/no options were used to assess function and wellbeing on this 12-item questionnaire. To score the SF-12, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status. It is one of the most widely used patient report outcome with well documented high validity, reliability, and responsiveness rate among many groups varying by age, sex, socio-economic status, geographical region, and clinical conditions (Ware et al, 2000).

  12 weeks

Study Arms (2)

Intervention (experimental) group

EXPERIMENTAL

These will receive a total of 6 sessions with a week's interval of radial shockwaves that will be performed using a (Storz Medical) device with the following manufacturer's parameters: 0.57mJ/mm2 (intensity 1.5 bar) applied as low energy, pulses 2000, frequency 15 Hz. The D20 transmitter (Ø 20 mm) headpiece will be used. Total treatment time including standard PT stretches and exercises would be 30 minutes). The radial shockwave will be delivered by designated physiotherapist, who will evaluate the participants before the treatment. Before the treatment, the treating physical therapist would ensure aseptic techniques, they would ensure the participants skin is intact and clean coupling gel will be used during the treatment. Furthermore prior to treatment, the myofascial triggers would be specifically confirmed by twitching response induced by a localized probe using a digital algometer.

Device: Radial shockwave therapy

Control (placebo) group

PLACEBO COMPARATOR

These will receive an identical treatment regime except that they will receive a none-therapeutic level energy shock of 0.03 mJ/mm2, an ineffective (a non-therapeutic) level of radial shockwave therapy, and participants will be blinded to their treatment by only hearing the sound from the shockwave machine.

Device: Radial shockwave therapy

Interventions

Radial shockwave therapy DEVICE

Shockwave Storz Medical device, Doulith SD1, Tower (BT)

Also known as: Shockwave Storz Medical device, Doulith SD1, Tower (BT)

Control (placebo) group; Intervention (experimental) group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19 and above
• Neck and or upper back pain localised the lateral or posterior neck and or upper back
• Palpable tenderness in the lateral or posterior neck and or upper back
• Trigger points in lateral or posterior neck and or upper back
• Able to give informed consent

You may not qualify if:

• Patients below 19 years of age
• History of:
• Malignancy
• Lung tissue
• Haemophiliacs or patients on anticoagulant therapy
• Visible tissue damage (skin petechiae \& microvasculature disruption)
• Metal implants - implanted cardiac stents \& heart valves
• Infection
• Rheumatic, respiratory, cardiovascular diseases
• Psychopathy
• Disorders of the vestibular and visual systems
• neck or shoulder surgery within a year,
• Recent history steroid injections to myofascial trigger point
• Pregnancy
• Diagnosed as:

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

Physical Rehabilitation Department, King Faisal Specialist Hospital & Research Centre

Riyadh, Riyadh Region, 11211, Saudi Arabia

Location

Related Publications (45)

• Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.

  PMID: 11871683 BACKGROUND

• Akturk S, Kaya A, Cetintas D, Akgol G, Gulkesen A, Kal GA, Gucer T. Comparision of the effectiveness of ESWT and ultrasound treatments in myofascial pain syndrome: randomized, sham-controlled study. J Phys Ther Sci. 2018 Mar;30(3):448-453. doi: 10.1589/jpts.30.448. Epub 2018 Mar 2.

  PMID: 29581669 BACKGROUND

• Asiri F, Tedla JS, D Alshahrani MS, Ahmed I, Reddy RS, Gular K. Effects of patient-specific three-dimensional lumbar traction on pain and functional disability in patients with lumbar intervertebral disc prolapse. Niger J Clin Pract. 2020 Apr;23(4):498-502. doi: 10.4103/njcp.njcp_285_19.

  PMID: 32246656 BACKGROUND

• Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996 May 11;312(7040):1215-8. doi: 10.1136/bmj.312.7040.1215.

  PMID: 8634569 BACKGROUND

• Cho YS, Park SJ, Jang SH, Choi YC, Lee JH, Kim JS. (2012). Effects of the combined treatment of extracorporeal shock wave therapy (ESWT) and stabilization exercises on pain and functions of patients with myofascial pain syndrome. J Phys Ther Sci; 24:1319-23.

  BACKGROUND

• Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

  PMID: 15928561 BACKGROUND

• Coombes BK, Bisset L, Vicenzino B. A new integrative model of lateral epicondylalgia. Br J Sports Med. 2009 Apr;43(4):252-8. doi: 10.1136/bjsm.2008.052738. Epub 2008 Dec 2.

  PMID: 19050004 BACKGROUND

• Eftekharsadat B, Fasaie N, Golalizadeh D, Babaei-Ghazani A, Jahanjou F, Eslampoor Y, Dolatkhah N. Comparison of efficacy of corticosteroid injection versus extracorporeal shock wave therapy on inferior trigger points in the quadratus lumborum muscle: a randomized clinical trial. BMC Musculoskelet Disord. 2020 Oct 19;21(1):695. doi: 10.1186/s12891-020-03714-3.

  PMID: 33076888 BACKGROUND

• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

  PMID: 11690728 BACKGROUND

• Fernandez-de-las-Penas C, Grobli C, Ortega-Santiago R, Fischer CS, Boesch D, Froidevaux P, Stocker L, Weissmann R, Gonzalez-Iglesias J. Referred pain from myofascial trigger points in head, neck, shoulder, and arm muscles reproduces pain symptoms in blue-collar (manual) and white-collar (office) workers. Clin J Pain. 2012 Jul;28(6):511-8. doi: 10.1097/AJP.0b013e31823984e2.

  PMID: 22673484 BACKGROUND

• Fischer AA. Documentation of myofascial trigger points. Arch Phys Med Rehabil. 1988 Apr;69(4):286-91.

  PMID: 3281631 BACKGROUND

• Fisher LD, Dixon DO, Herson J, Frankowski RK, Hearron MS & Peace KE (1990) Intention to treat in clinical trials. In: Peace KE, editor. Statistical issues in drug research and development. New York: Marcel Dekker.

  BACKGROUND

• Fleckenstein J, Zaps D, Ruger LJ, Lehmeyer L, Freiberg F, Lang PM, Irnich D. Discrepancy between prevalence and perceived effectiveness of treatment methods in myofascial pain syndrome: results of a cross-sectional, nationwide survey. BMC Musculoskelet Disord. 2010 Feb 11;11:32. doi: 10.1186/1471-2474-11-32.

  PMID: 20149248 BACKGROUND

• Galasso A, Urits I, An D, Nguyen D, Borchart M, Yazdi C, Manchikanti L, Kaye RJ, Kaye AD, Mancuso KF, Viswanath O. A Comprehensive Review of the Treatment and Management of Myofascial Pain Syndrome. Curr Pain Headache Rep. 2020 Jun 27;24(8):43. doi: 10.1007/s11916-020-00877-5.

  PMID: 32594264 BACKGROUND

• Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.

  PMID: 22607834 BACKGROUND

• Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221.

  PMID: 21897887 BACKGROUND

• Gur, A., Koca, I., Karagullu, H., Altindag, O., & Madenci, E. (2013). Comparison of the efficacy of ultrasound and extracorporeal shock wave therapies in patients with myofascial pain syndrome: a randomized controlled study. Journal of musculoskeletal Pain, 21(3), 210-216. DOI: 10.3109/10582452.2013.828824.

  BACKGROUND

• Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

  PMID: 12804509 BACKGROUND

• Haddad C, Sacre H, Obeid S, Salameh P, Hallit S. Validation of the Arabic version of the "12-item short-form health survey" (SF-12) in a sample of Lebanese adults. Arch Public Health. 2021 Apr 23;79(1):56. doi: 10.1186/s13690-021-00579-3.

  PMID: 33892801 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Jeon JH, Jung YJ, Lee JY, Choi JS, Mun JH, Park WY, Seo CH, Jang KU. The effect of extracorporeal shock wave therapy on myofascial pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):665-74. doi: 10.5535/arm.2012.36.5.665. Epub 2012 Oct 31.

  PMID: 23185731 BACKGROUND

• Jun JH, Park GY, Chae CS, Suh DC. The Effect of Extracorporeal Shock Wave Therapy on Pain Intensity and Neck Disability for Patients With Myofascial Pain Syndrome in the Neck and Shoulder: A Meta-Analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2021 Feb 1;100(2):120-129. doi: 10.1097/PHM.0000000000001493.

  PMID: 32520797 BACKGROUND

• Kiraly M, Bender T, Hodosi K. Comparative study of shockwave therapy and low-level laser therapy effects in patients with myofascial pain syndrome of the trapezius. Rheumatol Int. 2018 Nov;38(11):2045-2052. doi: 10.1007/s00296-018-4134-x. Epub 2018 Aug 31.

  PMID: 30171341 BACKGROUND

• Kruse RL, Alper BS, Reust C, Stevermer JJ, Shannon S, Williams RH. Intention-to-treat analysis: who is in? Who is out? J Fam Pract. 2002 Nov;51(11):969-71.

  PMID: 12485553 BACKGROUND

• Lauche R, Langhorst J, Dobos GJ, Cramer H. Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy. Complement Ther Med. 2013 Aug;21(4):342-7. doi: 10.1016/j.ctim.2013.04.005. Epub 2013 May 25.

  PMID: 23876565 BACKGROUND

• Lee, J. H., & Han, E. Y. (2013). A comparison of the effects of PNF, ESWT, and TPI on pain and function of patients with myofascial pain syndrome. Journal of Physical Therapy Science, 25(3), 341-344.

  BACKGROUND

• Li X, Wang R, Xing X, Shi X, Tian J, Zhang J, Ge L, Zhang J, Li L, Yang K. Acupuncture for Myofascial Pain Syndrome: A Network Meta-Analysis of 33 Randomized Controlled Trials. Pain Physician. 2017 Sep;20(6):E883-E902.

  PMID: 28934793 BACKGROUND

• Luan S, Zhu ZM, Ruan JL, Lin CN, Ke SJ, Xin WJ, Liu CC, Wu SL, Ma C. Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points. Am J Phys Med Rehabil. 2019 Aug;98(8):677-684. doi: 10.1097/PHM.0000000000001173.

  PMID: 31318748 BACKGROUND

• Manafnezhad J, Salahzadeh Z, Salimi M, Ghaderi F, Ghojazadeh M. The effects of shock wave and dry needling on active trigger points of upper trapezius muscle in patients with non-specific neck pain: A randomized clinical trial. J Back Musculoskelet Rehabil. 2019;32(5):811-818. doi: 10.3233/BMR-181289.

  PMID: 30883334 BACKGROUND

• McGovern, D. P. B. (2001). Randomized controlled trials. In: McGovern DPB, Valori RM, Summerskill WSM, eds. Key topics in evidence based medicine. Oxford: BIOS Scientific Publishers: 26 - 9.

  BACKGROUND

• Müller-Ehrenberg, H., & Licht, G. (2005). Diagnosis and therapy of myofascial pain syndrome with focused shock waves (ESWT). Med Orthop Tech, 5, 1-6.

  BACKGROUND

• Pool JJ, Ostelo RW, Hoving JL, Bouter LM, de Vet HC. Minimal clinically important change of the Neck Disability Index and the Numerical Rating Scale for patients with neck pain. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3047-51. doi: 10.1097/BRS.0b013e31815cf75b.

  PMID: 18091500 BACKGROUND

• Rodriguez CS. Pain measurement in the elderly: a review. Pain Manag Nurs. 2001 Jun;2(2):38-46. doi: 10.1053/jpmn.2001.23746.

  PMID: 11706769 BACKGROUND

• Sciotti VM, Mittak VL, DiMarco L, Ford LM, Plezbert J, Santipadri E, Wigglesworth J, Ball K. Clinical precision of myofascial trigger point location in the trapezius muscle. Pain. 2001 Sep;93(3):259-266. doi: 10.1016/S0304-3959(01)00325-6.

  PMID: 11514085 BACKGROUND

• Simons, D G. (1996) Clinical and Etiological Update of Myofascial Pain from Trigger Points, Journal of Musculoskeletal Pain, 4:1-2, 93-122, DOI: 10.1300/J094v04n01_07.

  BACKGROUND

• Travell, J. G., & Simons, D. G. (1999). Myofascial Pain and Dysfunction: The Trigger Point Manual. 2nd ed. (Vol 1). Baltimore, MD: Williams and Wilkins.

  BACKGROUND

• Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.

  PMID: 18395479 BACKGROUND

• Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

  PMID: 1834753 BACKGROUND

• Vickers AJ. Placebo controls in randomized trials of acupuncture. Eval Health Prof. 2002 Dec;25(4):421-35. doi: 10.1177/0163278702238055.

  PMID: 12449085 BACKGROUND

• Viera AJ, Bangdiwala SI. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med. 2007 Feb;39(2):132-7.

  PMID: 17273956 BACKGROUND

• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.

  PMID: 11124729 BACKGROUND

• Watson, P (2014) Shockwave therapy, available online at: shockwave Prof Time Watson.pdf.

  BACKGROUND

• Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res. 2012 Mar 20;7:11. doi: 10.1186/1749-799X-7-11.

  PMID: 22433113 BACKGROUND

• Yoo JI, Oh MK, Chun SW, Lee SU, Lee CH. The effect of focused extracorporeal shock wave therapy on myofascial pain syndrome of trapezius: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Feb;99(7):e19085. doi: 10.1097/MD.0000000000019085.

  PMID: 32049811 BACKGROUND

• Ogbeivor C, AlMubarak H, Akomolafe T, Alkahtani H, AlMugizel H, Marin I, Aldosari H, Aldhwayan N, Mohamed G, Alobthani K. The effectiveness of radial shockwave therapy on myofascial pain syndrome: a two-armed, randomized double-blind placebo-controlled trial. BMC Musculoskelet Disord. 2025 Apr 24;26(1):413. doi: 10.1186/s12891-025-08659-z.

  PMID: 40275291 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomisation allocation sequence will be based on computer-generated random sequence using permuted block size of 4 and concealed random allocation using sealed opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will make use a pragmatic, two-arm, parallel, doubled-blind, randomised controlled as the study design.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: April 21, 2022
• Primary Completion: July 10, 2023
• Study Completion: April 30, 2024
• Last Updated: March 17, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)