Clinical trial
Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
Name
AIBU-FTR-SK-02
Description
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
Trial arms
Trial start
2022-08-01
Estimated PCD
2023-07-30
Trial end
2024-02-27
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Static wrist splint treatment
Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.
Arms:
Splint, Tendon and nerve gliding exercise, local steroid injection
Tendon and nerve gliding exercises
Tendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position.
These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding).
Arms:
Tendon and nerve gliding exercise
Wrist local steroid injection
Wrist local steroid injection:
After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance.
Arms:
local steroid injection
Size
60
Primary endpoint
Visual Analogue Scale
Before Treatment
Visual Analogue Scale
8 week after treatment
Isokinetic Muscle Strength Measure
Before Treatment
Isokinetic Muscle Strength Measure
8 week after treatment
The hand grip strength
Before Treatment
The hand grip strength
8 week after treatment
The finger pinch strength
Before Treatment
The finger pinch strength
8 week after treatment
Boston Carpal Tunnel Syndrome Questionnaire
Before Treatment
Boston Carpal Tunnel Syndrome Questionnaire
8 week after treatment
Eligibility criteria
Inclusion Criteria:
* Patients with mild to moderate CTS confirmed by Electromyography
* Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present.
* Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present.
Exclusion Criteria:
* Having a history of trauma and operation on the wrist.
* Patients who have had previous injections from the wrist
* Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy
* Pregnant patients
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-01-30
1 organization
1 product
1 indication
Organization
Abant Izzet Baysal UniversityIndication
Carpal Tunnel Syndrome