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Completed

NCT Number: NCT02495298

Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 05716-150, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fascial manipulation

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Marta Imamura

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 13, 2015
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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