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Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02495298
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Marta Imamura, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Fascial Manipulation Procedure: Sham Fascial Manipulation Phase 2

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  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Fascial Manipulation for the Conservative Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial, Phase II
Study Start Date : August 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014


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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. Change from baseline in function on BCTQ score for function at 10 days and 3 months after the end of the treatment. [ Time Frame: Baseline, 10 days and 3 months after 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.

  3. Change from baseline in function on DASH score for function at 10 days and 3 [ Time Frame: Baseline, 10 days and 3 months after the treatment ]
    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.

  4. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495298


Locations
Brazil
Instituto de Medicina Fisica e Reabilitacao HCFMUSP
Sao Paulo, Brazil, 05716-150
Sponsors and Collaborators
Marta Imamura
Investigators
Principal Investigator: Marta Imamura, MD Instituto de Medicina Física e Reabilitação HCFMUSP

Responsible Party: Marta Imamura, Coordinator of the Clinical Trial Site of the Institute of Physical Medicine and Rehabilitation Medicine of HCFMUSP, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02495298     History of Changes
Other Study ID Numbers: Fascial Manipulation on CTS
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marta Imamura, University of Sao Paulo:
Fascial manipulation
Carpal Tunnel Syndrome

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries