Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Fascial Manipulation; Procedure: Sham Fascial Manipulation

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05716-150
    • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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

Collaborators and Investigators

• Sponsor: Marta Imamura

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Fascial manipulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: Fascial Manipulation on CTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No