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NCT Number: NCT05771220

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

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.

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Key information

Conditions

Adhesive Capsulitis of Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Thager General Hospital

Jeddah, Mecca Region, 21477, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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))

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Taif University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2023
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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