Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

NCT ID: NCT02495298

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fascial Manipulation

Intervention Type: PROCEDURE

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.

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.

Group Type: SHAM_COMPARATOR

Sham Fascial Manipulation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marta Imamura

OTHER

Sponsor Role: lead

Responsible Party

Marta Imamura

Coordinator of the Clinical Trial Site of the Institute of Physical Medicine and Rehabilitation Medicine of HCFMUSP

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Imamura, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Física e Reabilitação HCFMUSP

Locations

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Fascial Manipulation on CTS

Identifier Type: -

Identifier Source: org_study_id