Status:
UNKNOWN
Frozen Shoulder Single Arm Prospective Study
Lead Sponsor:
Allevio Pain Management Clinic
Conditions:
Frozen Shoulder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of combination of brachial plexus block plus physical therapy on quality of life improvement in patients with frozen shoulder condition via standard...
Detailed Description
STUDY OBJECTIVES The primary objective is to evaluate the effect of combination of regional anesthesia and physical therapy measured as an improvement in pain related disability scores of the impaired...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Diagnosis of unilateral or bilateral frozen shoulder, defined as greater than 50% limitation of passive ROM relative to the non affected side in one or more of three movement directions (i.e., abduction in the frontal plane, forward flexion in the sagittal plane, or external rotation in 0° of abduction) with a hard end feel
- Symptoms of frozen shoulder that had lasted for at least 3 months.
- Willing and able to provide informed consent and perform home-based exercises as instructed.
- Willing and able to complete study questionnaires
Exclusion
- Previous manipulation of the affected shoulder under anesthesia in the last year;
- Other rheumatic conditions involving the shoulder (e.g., rheumatoid arthritis, ankylosing Spondylitis,
- Fracture or dislocation of the affected shoulder;
- Previous shoulder surgery;
- Hill-Sachs lesion, severe osteoporosis, or malignancies in the shoulder region);
- Neurologic deficits affecting shoulder function;
- History of allergy to lidocaine;
- Corticosteroid injection in the affected shoulder during the receding 4 weeks.
- Non-English speakers;
- Active non- controlled mental disorders
- Multiple complete tear in ligaments of rotator cuff
- Any infection including COVID-19
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04687735
Start Date
January 1 2021
End Date
December 1 2022
Last Update
June 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Allevio Pain Management
Toronto, Ontario, Canada, M3B 3S6