Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome
|ClinicalTrials.gov Identifier: NCT02495298|
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : October 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Procedure: Fascial Manipulation Procedure: Sham Fascial Manipulation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Fascial Manipulation for the Conservative Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial, Phase II|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||April 2014|
Experimental: Treatment Fascial Manipulation
Seven patients with diagnosis of CTS, received five sessions of Fascial Manipulation performed by a physiotherapist. The sessions were performed once a week, and each session were 30 to 45 minutes long as to cover different painful spots.
Procedure: Fascial Manipulation
The Fascial Manipulation was performed by a physiotherapist on the spots indicated by clinician as the most painful ones due to CTS. The selected spots were informed to the physiotherapist after the clinical anamnesis.
Sham Comparator: Placebo Fascial Manipulation
Seven patients with diagnosis of CTS, received five sessions of Sham Fascial Manipulation performed by a physiotherapist. The sessions were performed once a week, and each session were 30 to 45 minutes long as to cover different painful spots.
Procedure: Sham Fascial Manipulation
After the clinical anamnesis, a physiotherapist performed the Fascial Manipulation on different spots, rather than the spots the clinician considered the most painful ones due to CTS.
- 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. ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495298
|Instituto de Medicina Fisica e Reabilitacao HCFMUSP|
|Sao Paulo, Brazil, 05716-150|
|Principal Investigator:||Marta Imamura, MD||Instituto de Medicina Física e Reabilitação HCFMUSP|