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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05771220
Other study ID # A01510
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date December 15, 2023

Study information

Verified date June 2024
Source Taif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the combined effects of radial extracorporeal shockwave therapy (rESWT) and evidence-based physical therapy (EBPT) interventions for patients with adhesive capsulitis. The main questions it aims to answer are: What is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone? How does the combination of rESWT and EBPT affect pain, range of motion, and functional outcomes in patients with adhesive capsulitis? Researchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis. The study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period. The primary outcomes will be pain and disability, while secondary outcomes will include shoulder range of motion, psychological distress, and health-related quality of life. These outcomes will be assessed at baseline, post-intervention, and 12 weeks post-randomization.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 15, 2023
Est. primary completion date October 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
radial extracorporeal shockwave therapy+ evidence-based physical therapy
The experimental group received six sessions of rESWT over six weeks in addition to an EBPT program. The rESWT procedure involved applying shockwaves to the affected area using a radial probe, with sessions lasting 10-15 minutes and consisting of up to 2000 impulses delivered at a frequency of 3-6 pulses per second and an energy intensity level of 1.8 bar, based on patient tolerance. Patients were seated or lying down during the rESWT procedure, with gel or oil applied to facilitate shockwave transmission through the skin. Additionally, participants received a 30-minute exercise program twice a week for 6 weeks, which included hot packs, stretching, range of motion exercises, and isometric shoulder and scapular exercises. They were also instructed to perform the same exercises at home daily.
sham radial extracorporeal shockwave therapy+ evidence-based physical therapy
The participants in the control group received six weeks of sham rESWT (radial extracorporeal shock wave therapy) combined with the EBPT (evidence-based physical therapy) program. The sham rESWT involved six sessions with a maximum of 200 impulses delivered at a low intensity, with the applicator placed on the affected area for the same duration as the experimental group. Additionally, participants received a 30-minute exercise program twice a week for 6 weeks, which included hot packs, stretching, range of motion exercises, and isometric shoulder and scapular exercises. They were also instructed to perform the same exercises at home daily.

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 allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale Visual analogue scale for pain intensity measurement baseline, and at 7 and 12 weeks
Primary Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) Shoulder disability was measured using the Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) questionnaire (0-100). It's an 11-item questionnaire that measures a patient's ability to perform specific upper extremity tasks, and higher scores on the scale indicate a higher disability baseline, and at 7 and 12 weeks
Secondary Depression Anxiety Stress Scales (DASS-12) Depression Anxiety Stress Scales, is made up of 12 self-report items baseline, and at 7 and 12 weeks
Secondary SF-12 The 12-Item Short Form Health Survey questionnaire (SF-12) is a very popular instrument for evaluating Health-Related Quality of Life. baseline, and at 7 and 12 weeks
Secondary Range of Motion (passive and active) Range of Motion is measured by goniometer baseline, and at 7 and 12 weeks
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