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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240320003

Enrollment

Registered

2024-03-20

Start date

2024-03-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen shoulder. Hyperbaric oxygen therapy Frozen shoulder

Interventions

Hyperbaric oxygen therapy with 100% at 45 feet sea water for 90 minutes once a day for five days consecutively. Physical therapy with cold pack to affected shoulder once a day for five days consecutiv

Experimental Procedure/Surgery,No Intervention No treatment

Treatment group,Controlled group

Eligibility

Sex/Gender

All

Age

35 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pain 5 days, 1 month and 3 months Visual analog scale	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Thailand

Contacts

Public ContactNaruebade Rungrattanawilai

Royal Thai Navy

Research.km65@gmail.com6638245735

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026