The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

The Effect of Extracorporeal Shockwave Therapy on Adhesive Capsulitis Shoulder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771220
• Other study ID #: A01510
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: May 2024
• Source: Taif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Adhesive capsulities or Frozen shoulder is one of the common causes of shoulder pain and disability in the upper extremity. It affects the functions of glenohumeral joint, limiting both active and passive movements of the shoulder. One way of non-surgical treatment method that has been receiving attention recently is extracorporeal shockwave therapy (ESWT). ESWT is a pulsed sound wave, characterized by short duration, high pressure amplitude, and relatively low tensile wave component. ESWT has beenrepotreatingtreat a variety of pain conditions effectively and safely. Purpose: The purpose of the present study is to determine whether ESWT could be effective in thetreatment of adhesive capsulitis or frozen shoulder.

Description:

Methods: Experiment Group patients were given shockwave therapy for 6 weeks as a one session per week follow up after 12 weeks. Control Group patients received shame shockwave therapy inaddition to traditional treatment the same period of the experiment group.Importance: Till date, only a few studies have reported the efficacy and clinical improvements obtained by extracorporeal shockwave therapy (ESWT) on frozen shoulder. Limited by asmall number of studies and insufficient outcomes, it is important and necessary to conduct a new randomized controlled trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a relapsed or episode of pain score =5 at the assessment with a past history of pain for at least 2 weeks.
• phase 1 or 2 frozen shoulder confirmed by a physician
• ROM restriction (>75% ROM loss in =2 directions including abduction, flexion and external rotation)
• no treatment other than analgesics with unresponsive ROM restriction for the past 2 months
• unwilling or waiting and did not undergo joint injection
• Diagnosed with shoulder adhesive capsulitis,
• =18 years
• Diabetes mellitus

Exclusion Criteria:

• bilateral shoulder involvement
• History of previous surgery on the shoulder
• Shoulder fracture
• Cancer
• Glenohumeral or Acromioclavicular arthritis
• Inflammatory disorders
• Bleeding disorders
• Presence of severe osteoporosis
• Pulmonary diseases
• Any neuromuscular disorders
• Pregnancy
• Implanted pacemaker

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Other:
• radial extracorporeal shockwave therapy+ evidence-based physical therapy
Participants will receive one session per week for 6 weeks on the affected tissue region which will be achieved by a sequence of 2000 shock wave pulses fired with a repetition frequency of 2 pulses per second. Energy level or intensity will be set at a tolerable level by patient (0.2mJ/mm2). The usual physical therapy care consists of hot pack (10min), stretching, pendulum exercises, isometrics exercises of shoulder one per week, and for 12 weeks. home exercises program (HEP)
• sham radial extracorporeal shockwave therapy+ evidence-based physical therapy
Participants will be treated one time a week over a six-week period. Placebo shockwave treatment (apply low intensity with low dose and frequency: intensity 0.1, freq 1, dose 200 shocks). The usual physical therapy care consists of hot pack (10min), stretching, pendulum exercises, isometrics exercises of shoulder one per week, and for 12 weeks. home exercises program (HEP)

Locations

Country	Name	City	State
Saudi Arabia	Al-Thager General Hospital	Jeddah	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Taif University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (14)

Agarwal S, Raza S, Moiz JA, Anwer S, Alghadir AH. Effects of two different mobilization techniques on pain, range of motion and functional disability in patients with adhesive capsulitis: a comparative study. J Phys Ther Sci. 2016 Dec;28(12):3342-3349. do — View Citation

Cao DZ, Wang CL, Qing Z, Liu LD. Effectiveness of extracorporeal shock-wave therapy for frozen shoulder: A protocol for a systematic review of randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14506. doi: 10.1097/MD.0000000000014506. — View Citation

Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443. — View Citation

Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916. — View Citation

Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7. — View Citation

Lee S, Lee S, Jeong M, Oh H, Lee K. The effects of extracorporeal shock wave therapy on pain and range of motion in patients with adhesive capsulitis. J Phys Ther Sci. 2017 Nov;29(11):1907-1909. doi: 10.1589/jpts.29.1907. Epub 2017 Nov 24. — View Citation

Muthukrishnan R, Rashid AA, Al-Alkharji F. The effectiveness of extracorporeal shockwave therapy for frozen shoulder in patients with diabetes: randomized control trial. J Phys Ther Sci. 2019 Jul;31(7):493-497. doi: 10.1589/jpts.31.493. Epub 2019 Jul 2. — View Citation

Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186. — View Citation

Park C, Lee S, Yi CW, Lee K. The effects of extracorporeal shock wave therapy on frozen shoulder patients' pain and functions. J Phys Ther Sci. 2015 Dec;27(12):3659-61. doi: 10.1589/jpts.27.3659. Epub 2015 Dec 28. — View Citation

Qiao HY, Xin L, Wu SL. Analgesic effect of extracorporeal shock-wave therapy for frozen shoulder: A randomized controlled trial protocol. Medicine (Baltimore). 2020 Jul 31;99(31):e21399. doi: 10.1097/MD.0000000000021399. — View Citation

Struyf F, Meeus M. Current evidence on physical therapy in patients with adhesive capsulitis: what are we missing? Clin Rheumatol. 2014 May;33(5):593-600. doi: 10.1007/s10067-013-2464-3. Epub 2013 Dec 28. — View Citation

Vahdatpour B, Taheri P, Zade AZ, Moradian S. Efficacy of extracorporeal shockwave therapy in frozen shoulder. Int J Prev Med. 2014 Jul;5(7):875-81. — View Citation

Yuan X, Zhou F, Zhang L, Zhang Z, Li J. Analgesic Effect of Extracorporeal Shock Wave Treatment Combined with Fascial Manipulation Theory for Adhesive Capsulitis of the Shoulder: A Retrospective Study. Biomed Res Int. 2018 Jan 18;2018:3450940. doi: 10.115 — View Citation

Zhang R, Wang Z, Liu R, Zhang N, Guo J, Huang Y. Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2022 Feb 4;10(2):23259671211062222. doi: 10.1177/23259671211062222. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	Visual analogue scale for pain measurement	3 months
Primary	Disabilities of the Arm, Shoulder, and Hand Quick version	Disabilities of the Arm, Shoulder, and Hand (DASH) score.	3 months
Secondary	Depression Anxiety Stress Scales	Depression Anxiety Stress Scales, is made up of 42 self-report items	3 months
Secondary	SF-36 (short version)	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.	3 months
Secondary	Range of Motion	Range of Motion is measured by goniometer	3 months