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Clinical Trial NCT06491745 for Frozen Shoulder, Corticosteroid Injection, Physical Therapy, Extracorporeal Shock Wave Therapy, Rehabilitation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder 94 Randomized

Recruiting
Clinical Trial NCT06491745 is an interventional study for Frozen Shoulder, Corticosteroid Injection, Physical Therapy, Extracorporeal Shock Wave Therapy, Rehabilitation that is recruiting. It started on August 1, 2024 with plans to enroll 94 participants. Led by Shin Kong Wu Ho-Su Memorial Hospital, it is expected to complete by December 31, 2028. The latest data from ClinicalTrials.gov was last updated on December 30, 2025.
Brief Summary
Frozen shoulder, or adhesive capsulitis of the shoulder, is a common clinical problem characterized by pain, loss of both passive and active range of motion (ROM) of glenohumeral joint (GHJ), leads to functional limitation, and reduces quality of life. Primary frozen shoulder occurs without any obvious connection to any other condition, and secondary frozen shoulder is related to some medical problems, such as an inj...Show More
Detailed Description
Intra-articular and subdeltoid bursal corticosteroid injection and physical therapy (PT) are commonly used nonsurgical treatments for frozen shoulder and have shown good benefits. However, because of complex clinical pictures and overlapping stages, even after the above treatments, pain and contracture of affected shoulder may still exist, and adjuvant therapy is often needed throughout the course of treatment. Over ...Show More
Official Title

Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder?

Conditions
Frozen ShoulderCorticosteroid InjectionPhysical TherapyExtracorporeal Shock Wave TherapyRehabilitation
Other Study IDs
  • 20231204R
  • NSTC 113-2314-B-341-003 - (Other Grant/Funding Number) (National Science and Technology Council)
  • NSTC 114-2314-B-341-001 - (Other Grant/Funding Number) (National Science and Technology Council)
NCT ID Number
NCT06491745
Start Date (Actual)
2024-08-01
Last Update Posted
2025-12-30
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
94
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Frozen shoulder
corticosteroid injection
physical therapy
extracorporeal shock wave therapy
rehabilitation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorESWT+PT+corticosteroid injection, ESWT group
ESWT group. Patients in the ESWT group will receive ESWT, physical therapy, and both shoulder joint (glenohumeral joint, GHJ) and SASD bursa injection for 2 times in a 2-week interval. 3ml triamcinolone (1ml triamcinolone= 10mg) will be added to 3ml 1% xylocaine to make 6ml injectate. Among them, 4ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. After wi...Show More
Sham ESWT+PT+corticosteroid injection, SHAM group.
SHAM group. The participants will receive the same dosage and technique of corticosteroid posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval as participants do in the ESWT group. For creating a single-blinded condition, they will also receive 4 ESWT treatments at weekly interval except that the energy flux density is set at 0.04 mJ/mm2. For sham ESWT, the machine still makes a noise with every sh...Show More
Active ComparatorSham ESWT+PT+corticosteroid injection, SHAM group.
SHAM group. The participants will receive the same dosage and technique of corticosteroid posterior GHJ and SASD bursa injection for 2 times at 2 weekly interval as participants do in the ESWT group. For creating a single-blinded condition, they will also receive 4 ESWT treatments at weekly interval except that the energy flux density is set at 0.04 mJ/mm2. For sham ESWT, the machine still makes a noise with every sh...Show More
ESWT+PT+corticosteroid injection, ESWT group
ESWT group. Patients in the ESWT group will receive ESWT, physical therapy, and both shoulder joint (glenohumeral joint, GHJ) and SASD bursa injection for 2 times in a 2-week interval. 3ml triamcinolone (1ml triamcinolone= 10mg) will be added to 3ml 1% xylocaine to make 6ml injectate. Among them, 4ml injectate will be injected into the posterior GHJ with a 7 cm 23-gauge needle under ultrasound (US) guidance. After wi...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The Shoulder Pain and Disability Index (SPADI)
The SPADI is a self-administered questionnaire that evaluate the pain and disability of shoulder diseases. It has 2 subclasses (pain and disability) that consists of 13 items. The pain domain has 5 items and the disabilities domain has 8 items. The SPADI score, which ranges between 0 (best score) and 100 (worst score), is calculated by averaging the scores from the 2 subclasses.
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The pain visual analog scale (VAS)
The pain VAS is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain.22 The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of pain VAS is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
Change between baseline and at 1 months, 2 months, 4 months, 6 months after the beginning of the treatment.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
  1. age between 20 to 80 years old;
  2. shoulder pain for ≥ 1 month;
  3. > 30% loss of passive range of motion (ROM) of the affected shoulder in external rotation and/or abduction, comparing with the sound side;
  4. pain visual analog scale on maximal passive external rotation or abduction > 4;
  5. showing willing to receive ESWT, shoulder joint injection, and attend regular physical therapy programs for 8 weeks.

  1. severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
  2. uncontrolled DM;
  3. rotator cuff tear or calcification of the affected shoulder;
  4. fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
  5. a history of drug allergy to local anesthetics or corticosteroids;
  6. pregnancy;
  7. receiving ESWT, corticosteroid joint or bursa injection of the affected shoulder during the preceding three months
Shin Kong Wu Ho-Su Memorial Hospital logoShin Kong Wu Ho-Su Memorial Hospital
Study Responsible Party
Lin-Fen Hsieh, Principal Investigator, Study Principal Investigator, Shin Kong Wu Ho-Su Memorial Hospital
Study Central Contact
Contact: Lin-Fen Hsieh, +886-28332211, [email protected]
1 Study Locations in 1 Countries
Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
Lin-Fen Hsieh, M.D., Contact, +886-28332211, [email protected]
Recruiting