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Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

M

Marta Imamura

Status and phase

Completed
Phase 2

Conditions

Carpal Tunnel Syndrome

Treatments

Procedure: Sham Fascial Manipulation
Procedure: Fascial Manipulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02495298
Fascial Manipulation on CTS

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

14 participants in 2 patient groups

Treatment Fascial Manipulation
Experimental group
Description:
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.
Treatment:
Procedure: Fascial Manipulation
Placebo Fascial Manipulation
Sham Comparator group
Description:
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.
Treatment:
Procedure: Sham Fascial Manipulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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