NCT04687735UnknownNot Applicable
Minimally Invasive Technique to Increase the Range of Motion of the Shoulder Joint in Frozen Shoulder: Single Arm Prospective Study
Allevio Pain Management Clinic1 site in 1 country34 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- changes in disability score
Study Overview
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 questionnaires.
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 shoulder using the Shoulder Disability Questionnaire (SDQ), Shoulder Pain and Disability Index (SPADI), and improvement in pain score measured by Brief Pain Inventory (BPI).
The secondary objectives are to evaluate the effect of treatment on the following:
- Anxiety, measured by General Anxiety Disorder Questionnaire (GAD-7)
- Depression, measured by Beck's Depression Inventory (BDI)
- Satisfaction, measured by Global Improvement and Satisfaction Score (GISS) STUDY DESIGN This is as a single-center, prospective cohort study. The study does not imply any new intervention; all decisions regarding the treatment will be made at the sole discretion of the treating physician as part of clinical care. The study will be conducted over a period of 14 months, including approximately 1-2 months of enrolment, 4-6 weeks of treatment and follow-up at 3, 6, 12 months after the initiation of treatment for frozen shoulder. Treatment 1 can be scheduled along with baseline consult and screening (Day 0), three to five more treatment visits (Treatment 2 to Treatment 6) will be scheduled weekly (4-6 treatments in total), and follow up visits on 3, 6, and 12 months (with ±1week window). If patient has achieved any early full ROM, treatment will be stopped according to the physicians' decision. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada. Research Ethics approvals will be sought.
STUDY POPULATION Patients with unilateral or bilateral frozen shoulder in any stage will be screened for study eligibility.
STUDY INTERVENTION
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Intervention arm
Experimental
Patients with frozen shoulders at any stage
Intervention: Intervention after nerve block (Other)
Outcomes
Primary Outcomes
changes in disability score
Time Frame: 12 months
measured by Shoulder Disability Questionnaire (descriptive format No= no disability, Yes= disable)
Secondary Outcomes
- Frequency and duration of treatment related side(12 months)
- Changes in pain score (If there is any pain)(12 months)
- Changes in anxiety score(12 months)
- Changes in depression score(12 months)
- Changes in treatment satisfaction(12 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
The study of effectiveness of brachial plexus block under radiographic monitoring during shoulder operatiothe patients who were scheduled to the surgery of distal clavicle or upper limbJPRN-UMIN000018809Telephone East Corporation Sapporo Hospital40
Completed
Not Applicable
Clinical Research of Retrograde Infraclavicular Brachial Plexus BlockadeUpper ExtremityNCT01075503Beijing Jishuitan Hospital90
Completed
Not Applicable
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder ArthroscopyShoulder and Upper Arm InjuryNCT04941235Minia University80
Completed
Not Applicable
Effectiveness of nerve block in preventing complex regional pain syndrome after radius fracture surgeriesCondition 1: Complex Regional Pain Syndrome. Condition 2: Distal Radius Fracture.Shoulder-hand syndrome Sudeck's atrophy Sympathetic reflex dystrophyFracture of lower end of radiusIRCT201110267919N1Tehran University of Medical Sciences50
Unknown
Not Applicable
Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus BlockScaphoid FracturesDistal Radius FracturesWrist Injury ArthrodesisNCT02208245Federal University of São Paulo46