Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis

NCT05771220 | Completed

• 1 other identifier: A01510
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adhesive Capsulitis of Shoulder

Keywords

Frozen shoulder; Extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale

  Visual analogue scale for pain intensity measurement (0 (no pain) - 10 (worst pain))

  baseline, and at 7 and 12 weeks

• 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. The scale ranges from 0 to 100; where higher score indicates higher disability.

  baseline, and at 7 and 12 weeks

Secondary Outcomes (3)

• Depression Anxiety Stress Scales (DASS-12)

  baseline, and at 7 and 12 weeks

• Short Form-12

  baseline, and at 7 and 12 weeks

• Range of Motion (passive and active)

  baseline, and at 7 and 12 weeks

Study Arms (2)

radial extracorporeal shockwave therapy+ evidence-based physical therapy

EXPERIMENTAL

radial extracorporeal shockwave therapy + evidence-based physical therapy

Other: radial extracorporeal shockwave therapy+ evidence-based physical therapy

sham radial extracorporeal shockwave therapy + evidence-based physical therapy

PLACEBO COMPARATOR

sham radial extracorporeal shockwave therapy+ evidence-based physical therapy

Other: sham radial extracorporeal shockwave therapy+ evidence-based physical therapy

Interventions

radial extracorporeal shockwave therapy+ evidence-based physical therapy OTHER

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.

radial extracorporeal shockwave therapy+ evidence-based physical therapy

sham radial extracorporeal shockwave therapy+ evidence-based physical therapy OTHER

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.

sham radial extracorporeal shockwave therapy + evidence-based physical therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taif University: lead

Study Sites (1)

Al-Thager General Hospital

Jeddah, Mecca Region, 21477, Saudi Arabia

Location

Related Publications (15)

• 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.

  PMID: 29200621 RESULT

• 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.

  PMID: 31417208 RESULT

• 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.

  PMID: 19194024 RESULT

• 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.

  PMID: 25104999 RESULT

• 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.

  PMID: 28405218 RESULT

• 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.

  PMID: 30762780 RESULT

• 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.

  PMID: 33185587 RESULT

• 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. doi: 10.1589/jpts.28.3342. Epub 2016 Dec 27.

  PMID: 28174448 RESULT

• 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.

  PMID: 24284277 RESULT

• 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: 10.1155/2018/3450940. eCollection 2018.

  PMID: 29581969 RESULT

• 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.

  PMID: 26834326 RESULT

• 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.

  PMID: 24374758 RESULT

• 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. eCollection 2022 Feb.

  PMID: 35141337 RESULT

• 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.

  PMID: 32756135 RESULT

• Sharahili TM, Alzahrani HA. Effect of radial extracorporeal shockwave therapy combined with evidence-based physical therapy for adhesive capsulitis of the shoulder: A randomized controlled trial. Saudi Med J. 2025 Jul;46(7):816-824. doi: 10.15537/smj.2025.46.7.20250213.

  PMID: 40628437 DERIVED

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor; Department of Physical Therapy

Model Details: Randomized controlled trial, single blinded, placebo

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 16, 2023
• Study Start: May 15, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

SA (1)