Clinical Trial: Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Fascial Manipulation for the Conservative Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial, Phase II
Brief Summary:
The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction, functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS). Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed.
The study is blind for the patient and the raters.
Detailed Summary:
This is a prospective, randomized, placebo controlled, rater blind trial to evaluate the effectiveness of Fascial Manipulation as a therapy for CTS. Fascial Manipulation is an intense friction performed by the elbows or the distal extremities of the interphalangeal articulation of the index finger for some minutes as to promote hyperemia to restore the collagen fibers ability to slide against each other. The friction lasts from 2 to 4 minutes.
In this trial, 14 patients were randomized in two groups: The intervention group received fascial manipulation for CTS and the other group, received fascial manipulation on spots not related to CTS. This last group was the placebo control group.
The treatment was performed once a week for 5 weeks consecutively and the follow up visits for the assessments were performed 10 days and 3 months after the end of the treatment.
Sponsor: Marta Imamura
Current Primary Outcome: Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment. [ Time Frame: Baseline and 10 days after end of the treatment. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in pain on the VAS score for pain at 3 months after the end of the treatment. [ Time Frame: Baseline and 3 months after end of the treatment. ]
- Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of the treatment. [ Time Frame: Baseline, 10 days and 3 months after the treatment ]The Boston Carpal Tunnel Syndrome Questionnaire is a self rated evaluation which assesses the function, with 8 items, and the symptoms, with 11 items, of patients with CTS. Each item is a 5-point scale.
- Change from baseline in function on DASH score for function at 10 days and 3 [ Time Frame: Baseline, 10 days and 3 months after the treatment ]The DASH scale is a self rated evaluation for upper limbs which assesses symptoms and function with 30 items in total. Each arm has a score from 1 to 5, in which highest score indicates highest incapacities.
- Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment [ Time Frame: Baseline and 10 days after the treatment ]
Original Secondary Outcome: Same as current
Information By: University of Sao Paulo
Dates:
Date Received: July 8, 2015
Date Started: August 2013
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016
