Clinical trial NCT04474145: The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
Official title: The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Hydrodilatation
Joint Mobilization
Corticosteroid Injection
Physical Therapy
Rehabilitation
Keywords: frozen shoulder
hydrodilatation
joint mobilization
corticosteroid injection
physical therapy
rehabilitation
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2020-07-16
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of combination of hydrodilatation, corticosteroid injection, and joint mobilization for treatment of frozen shoulder, compared with general physical therapy.

Detailed description: Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and active range of motion (ROM) of glenohumeral joint, and leads to disability, functional limitation, and decreasing quality of life. FS is usually treated with conservative treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation, intra-articular steroid injection, etc.. The short-term effect of each treatment is variable, and the long-term effect is not established. Clinically combination of each treatment is common, but types of combination, and the effect of combination is still not well studied. We aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and general physiotherapy to treat frozen shoulder and compare the long-term effect with general physical therapy alone.

This is a prospective single-blind randomized controlled trial. 70 participants will be recruited from the outpatient clinic of the department of Physical Medicine and Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline) through both anterior and posterior shoulder joint in a two-weekly interval. In addition, joint mobilization and general physiotherapy (stretch exercise and physical modalities) will also be given, 2 times a week, for 8 weeks. The PT group will receive general physical therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36), and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations. We expect that the COMB group will recover sooner and better than the PT group.

Eligibility criteria: Inclusion Criteria:

1. . age between 20 to 80 years old;
2. . chronic shoulder pain for ≥ 3 months;
3. . \> 30% loss of passive range of motion (ROM) of the affected shoulder in either external rotation or abduction, comparing with the sound side;
4. . visual analog scale for pain on maximal passive external rotation or abduction \> 4.

Exclusion Criteria:

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. . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.

Primary outcomes:
measure: Shoulder Pain and Disability Index（SPADI）
timeFrame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary outcomes:
measure: Visual analog scale（VAS）
timeFrame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
measure: Range of motion（ROM）
timeFrame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
measure: Shoulder Disability Questionnaire（SDQ）
timeFrame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
measure: The 36-item Short Form Health Survey（SF-36）
timeFrame: change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh
role: PRINCIPAL_INVESTIGATOR
References: