Clinical trial NCT02495298: Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome
Official title: Evaluation of Fascial Manipulation for the Conservative Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial, Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Keywords: Fascial manipulation
Carpal Tunnel Syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* CTS degrees Ia, Ib and II diagnosis according to clinical evaluation and electroneuromyography;
* Wrist and finger paresthesia for more than 3 months prior to screening visit;
* Moderate to intense pain: VAS\>4.
* Ability to understand and respond to the questionnaires used in the trial;
* Ability to understand the Informed Consent Form;
* Sign the Informed Consent Form.

Exclusion Criteria:

* Psychiatric disorders;
* Fibromyalgia;
* Rheumatologic diseases;
* Other conditions related to CTS, as renal failure, diabetes, acromegaly, hyperthyroidism, multiple myeloma;
* History of neoplasia;
* History of surgery at Carpal Tunnel;
* History of use of illegal drugs;
* History of chronic use of corticosteroids;
* Corticosteroid infiltration one month prior to inclusion in the trial.

Primary outcomes:
measure: Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.
timeFrame: Baseline and 10 days after end of the treatment.
Secondary outcomes:
measure: Change from baseline in pain on the VAS score for pain at 3 months after the end of the treatment.
timeFrame: Baseline and 3 months after end of the treatment.
measure: Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of the treatment.
timeFrame: Baseline, 10 days and 3 months after the treatment
measure: Change from baseline in function on DASH score for function at 10 days and 3
timeFrame: Baseline, 10 days and 3 months after the treatment
measure: Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment
timeFrame: Baseline and 10 days after the treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Study officials:
affiliation: Instituto de Medicina Física e Reabilitação HCFMUSP
name: Marta Imamura, MD
role: PRINCIPAL_INVESTIGATOR
References: