The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder

Rehabilitation Clinical Trial

Official title:

The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474145
• Other study ID #: 20191212R
• Secondary ID: NSTC 109-2314-B-
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Corticosteroid Injection
• Frozen Shoulder
• Hydrodilatation
• Joint Mobilization
• Physical Therapy
• Rehabilitation

Intervention

Procedure:
• Comb group
Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks. The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, a21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.
• PT group
The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index(SPADI)		change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary	Visual analog scale(VAS)	The VAS for pain 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. 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 VAS for pain is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.	change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary	Range of motion(ROM)	All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.	change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary	Shoulder Disability Questionnaire(SDQ)	The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst possible condition).	change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary	The 36-item Short Form Health Survey(SF-36)	The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.	change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.