Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Evaluation of Fascial Manipulation for the Conservative Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial, Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495298
• Other study ID #: Fascial Manipulation on CTS
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2015
• Last updated: October 3, 2016
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Fisica e Reabilitacao HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Marta Imamura

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.		Baseline and 10 days after end of the treatment.	No
Secondary	Change from baseline in pain on the VAS score for pain at 3 months after the end of the treatment.		Baseline and 3 months after end of the treatment.	No
Secondary	Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of 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.	Baseline, 10 days and 3 months after the treatment	No
Secondary	Change from baseline in function on DASH score for function at 10 days and 3	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.	Baseline, 10 days and 3 months after the treatment	No
Secondary	Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment		Baseline and 10 days after the treatment	No