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

July 18, 2024 updated by: Hosam Alzahrani, Taif University

Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Mecca
      • Jeddah, Mecca, Saudi Arabia, 21477
        • Al-Thager General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radial extracorporeal shockwave therapy+ evidence-based physical therapy
radial extracorporeal shockwave therapy + evidence-based physical therapy
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.
Placebo Comparator: sham radial extracorporeal shockwave therapy + evidence-based physical therapy
sham radial extracorporeal shockwave therapy+ evidence-based physical therapy
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: baseline, and at 7 and 12 weeks
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)
Time Frame: baseline, and at 7 and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scales (DASS-12)
Time Frame: baseline, and at 7 and 12 weeks
Depression Anxiety Stress Scales, is made up of 12 self-report items. It is a 12-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress. It ranges 0-144, where higher score on the scale denotes higher endorsement of mental distress symptoms.
baseline, and at 7 and 12 weeks
Short Form-12
Time Frame: baseline, and at 7 and 12 weeks
The 12-Item Short Form Health Survey questionnaire (SF-12; 0-100) is a very popular instrument for evaluating Health-Related Quality of Life.HIgher score on the scale indicates better Health-Related Quality of Life.
baseline, and at 7 and 12 weeks
Range of Motion (passive and active)
Time Frame: baseline, and at 7 and 12 weeks

Range of Motion is measured by goniometer. Higher score on goniometer indicates better range of motion.

Flexion: 0-180 Abduction: 0-180 Internal rotation: 0-90 External rotation: 0-90
baseline, and at 7 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

October 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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