The effects of HBOT on pain reduction after ARCR.

JRCT ID: jRCTs062240042

Registered date:01/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: rotator cuff tear
• Date of first enrollment: 01/08/2024
• Target sample size: 120
• Study type: Interventional
• Intervention(s): hyperbaric oxygen therapy

Outcome(s)

• Primary Outcome: Change in shoulder pain visual analogue scale (VAS) scores up to two weeks postoperatively, using the second postoperative day as the baseline.

Secondary Outcome

Change in shoulder pain visual analogue scale (VAS) scores at each evaluation time point (3 days, 1 week, 3 weeks, 4 weeks, 8 weeks, and 12 weeks postoperatively).
Shoulder pain VAS scores and their progression at each evaluation time point (2 days, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks postoperatively).
Change and rate of change in physical examination findings at each evaluation time point (1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks postoperatively), using the second postoperative day as the baseline: Maximum circumference of the forearm, maximum circumference of the upper arm, range of motion (elbow and wrist joints), grip strength.
Change in the number of criteria met for the diagnosis of CRPS according to the Budapest criteria at each evaluation time point (1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks postoperatively).
Incidence and rate of occurrence of CRPS and CRPS-like symptoms at each evaluation time point (2 days, 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks postoperatively).
Postoperative complications.
Adverse events associated with HBOT.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Patients who aged between 50 and 85 years at the time of consent.
2. Patients who are scheduled for arthroscopic rotator cuff repair as part of routine clinical practice and are able to attend regular follow-up visits postoperatively.
3. Patients who are capable of effective communication (able to undergo physical examination, medical history taking, and scoring surveys).

Exclude criteria

Patients who meet any of the following criteria will be excluded from this study:
1. Patients who have been diagnosed with CRPS (Complex Regional Pain Syndrome) before surgery.
2. Patients with a history of surgical treatment on the affected shoulder.
3. Patients with functional impairment of the affected upper limb due to diseases other than rotator cuff tears.
4. Patients unable to undergo MRI examinations due to implanted devices.
5. Women who are pregnant or may be pregnant.
6. Absolute contraindications for HBOT : Tension pneumothorax.
7. Relative contraindications for HBOT: (i) Spontaneous pneumothorax, bronchial asthma, chronic lung disease (such as emphysema), nasal polyps, upper respiratory inflammation, (ii) sinus constriction, (iii) history of tympanic membrane trauma, history of exudative otitis media, (iv) patients with difficulty in Eustachian tube opening, (v) postoperative retinal detachment, (vi) skull base fractures, pneumocephalus, brain tumors, (vii) seizure disorders, (viii) patients with a history of open chest surgery who may experience rapid ventilatory failure, (ix) potential for aspiration or choking, (x) serious arrhythmias or other significant respiratory and circulatory disorders, (xi) claustrophobia.
8. Other cases deemed inappropriate by the study investigator.

Related Information

• Primary Sponsor: Ishida Koji