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

NCT04474145 | Completed DMC

• 3 other identifiers: 20191212RNSTC 109-2314-B-341-002NSTC 110-2314-B-341-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frozen Shoulder; Hydrodilatation; Joint Mobilization; Corticosteroid Injection; Physical Therapy; Rehabilitation

Keywords

frozen shoulder; hydrodilatation; joint mobilization; corticosteroid injection; physical therapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index（SPADI）

  change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.

Secondary Outcomes (4)

• Visual analog scale（VAS）

  change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.

• Range of motion（ROM）

  change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.

• Shoulder Disability Questionnaire（SDQ）

  change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.

• The 36-item Short Form Health Survey（SF-36）

  change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.

Study Arms (2)

Comb group

ACTIVE COMPARATOR

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.

Procedure: Comb group

PT group

ACTIVE COMPARATOR

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.

Procedure: PT group

Interventions

Comb group PROCEDURE

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.

Comb group

PT group PROCEDURE

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.

PT group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
• Uncontrolled DM;
• Rotator cuff tear or calcification of the affected shoulder;
• Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
• a history of drug allergy to local anesthetics or corticosteroids;
• receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Lin-Fen Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: August 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

TW (1)