Adhesive Capsulitis of Shoulder
Conditions
Keywords
Frozen shoulder, Extracorporeal shockwave therapy
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.
Interventions
OTHERradial 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.
OTHERsham 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.
Sponsors
Taif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blinded
Intervention model description
Randomized controlled trial, single blinded, placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | baseline, and at 7 and 12 weeks | Visual analogue scale for pain intensity measurement (0 (no pain) - 10 (worst pain)) |
| Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) | 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
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scales (DASS-12) | 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. |
| Short Form-12 | 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. |
| Range of Motion (passive and active) | 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 |
Countries
Saudi Arabia
Outcome results
None listed