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Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Fascial Manipulation
Sham Fascial Manipulation
Sponsored by
Marta Imamura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Fascial manipulation, Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Instituto de Medicina Fisica e Reabilitacao HCFMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Fascial Manipulation

Placebo Fascial Manipulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.

Secondary Outcome Measures

Change from baseline in pain on the VAS score for pain at 3 months after the 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.
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.
Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment

Full Information

First Posted
July 8, 2015
Last Updated
October 3, 2016
Sponsor
Marta Imamura
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1. Study Identification

Unique Protocol Identification Number
NCT02495298
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marta Imamura

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Fascial manipulation, Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Fascial Manipulation
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Fascial Manipulation
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Fascial Manipulation
Intervention Description
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
Intervention Name(s)
Sham Fascial Manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in pain on the VAS score for pain at 10 days after the end of the treatment.
Time Frame
Baseline and 10 days after end of the treatment.
Secondary Outcome Measure Information:
Title
Change from baseline in pain on the VAS score for pain at 3 months after the end of the treatment.
Time Frame
Baseline and 3 months after end of the treatment.
Title
Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of the treatment.
Description
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.
Time Frame
Baseline, 10 days and 3 months after the treatment
Title
Change from baseline in function on DASH score for function at 10 days and 3
Description
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.
Time Frame
Baseline, 10 days and 3 months after the treatment
Title
Change from baseline in nerve conduction on Electroneuromyography test for nerve conduction at 10 days after the end of the treatment
Time Frame
Baseline and 10 days after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Imamura, MD
Organizational Affiliation
Instituto de Medicina Física e Reabilitação HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
City
Sao Paulo
ZIP/Postal Code
05716-150
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

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