Effectiveness of Hyperbaric Oxygen Therapy and Conventional Treatment Versus Conventional Treatment Alone in Patients with Frozen Shoulder ; a Multicenter Randomized Controlled Trial.

Phase 2

Recruiting

• Conditions: Frozen shoulder.; Hyperbaric oxygen therapy; Frozen shoulder

• Registration Number: TCTR20240320003
• Lead Sponsor: Queen Sirikit Naval Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Last Update Posted: 19 August 2024
• Study Completion: 2025-09-12

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of frozen shoulder
2. Be diagnosed both before and after ethical approval of this proposal, from any primary doctor.
3. Onset of shoulder pain at least 2 months and not more than 9 months, as a first phase of frozen shoulder.
4. Normal radiographic study.
5. Consent to join the study.
6. Able to continue treatment protocol for 5 days.

Exclusion Criteria

1. History of previous shoulder trauma.
2. History of previous shoulder surgery.
3. History of previous shoulder infection.
4. History of inflammatory joint disease.
5. History of malignant.
6. History of shoulder injection with corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs)
7. Contraindication to hyperbaric oxygen therapy such as untreated pneumothorax, lung cyst, and uncontrolled seizure.
8. Allergy or contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) or omeprazole such as gastrointestinal bleeding, chronic kidney disease, chronic liver disease, and current aspirin use from other medical condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain 5 days, 1 month and 3 months Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Range of motion in forward flexion 5 days, 1 month and 3 months Degree,Range of motion in abduction 5 days, 1 month and 3 months Degree,Range of motion in adduction-external rotation 5 days, 1 month and 3 months Degree,Range of motion in internal rotation 5 days, 1 month and 3 months Spine level,Functional outcome 5 days, 1 month and 3 months American shoulder and elbow surgeons (ASES) score,Functional outcome 5 days, 1 month and 3 months Shoulder pain and disability index (SPADI),Functional outcome 5 days, 1 month and 3 months Disability of the arm, shoulder and hand (DASH) score,Functional outcome 5 days, 1 month and 3 months Short form 36 (SF-36)