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NCT Number: NCT02698085

Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the neuromusculoskeletal system. In the clinical practice a favorable effect is observed in patients with carpal tunnel syndrome, but there is no published studies evaluating the results os this technique.

The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a placebo.

For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of carpal tunnel syndrome (low to moderate intensity) with a neurophysiological test.

Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the other placebo. Both groups receive 5 treatment sessions.

The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in placebo group, when the intervention finish the investigators will be given the opportunity to receive the actual technique

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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

Not applicable

Primary location

Sandra Jiménez

Zaragoza, 50010, Spain

About this study

The investigators selected patients diagnosed with carpal tunnel syndrome with electroneurogram, if they meet the inclusion criteria are offered to take part in this study.

When the patient agree to participate and signed informed consent, the investigators collected dependent variables considered (symptoms, mechanosensitivity, functional capacity with upper limb, tractor speed of neural conduction ...) and the patient is assigned to an intervention group: real or placebo. Each patient receives treatment 5 sessions trascurriendo intersessional 2- 5 days. After 5 sessions the investigators remeasured the same variables. In addition, a month later they remeasured again symptoms and functional capacity with upper limb. Finally, they were shown the technique they have received. If the patient has received the technical placebo he/she is given the opportunity to receive 5 sessions of the actual technique.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)

Exclusion criteria

  • Severe carpal tunnel syndrome
  • Previous surgery on the hand
  • hormonal factors: diabetes, thyroids pathologies, pregnant
  • cervical disfunctions
  • ulcerations or skins disorders

Treatment and study plan

Actual Diacutaneous Fibrolysis

Other

Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.

Sham Diacutaneous Fibrolysis

Other

Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula but without effect in the muscle because no penetrate in deep tissue

Primary outcomes

  1. Intensity symptoms pre-intervention with a visual analogic scale

    Time frame: pre-intervention

    The investigators measure the intensity of symptoms with a visual analogic scale at baseline.

  2. Intensity symptoms post-intervention with a visual analogic scale

    Time frame: post-intervention

    The investigators measure the intensity of symptoms with a visual analogic scale at the end of the intervention (2 weeks after pre-intervention) the investigators measured the intensity of symptoms (through study completion, an average 15 days)

  3. Intensity symptoms after month with a visual analogic scale

    Time frame: after month

    The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.

Secondary outcomes

  1. Upper limb function pre-intervention with a validated questionnaire (DASH)

    Time frame: pre-intervention

    The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.

  2. Mechanosensitivity of median nerve pre-intervention with neurodynamic test

    Time frame: Pre-intervention

    The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.

  3. Mechanosensitivity of median nerve post-intervention with neurodynamic test

    Time frame: post-intervention

    The investigators measure the mechanosensitivity of median nerve with neurodynamic test at the end of the intervention (through study completion, an average 15 days).

  4. Neurophysiological test pre-intervention

    Time frame: pre-intervention

    The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline

  5. Neurophysiological test post-intervention

    Time frame: post-intervention

    The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at the end of the intervention (through study completion, an average 15 days)

  6. Upper limb function post-intervention with a validated questionnaire (DASH)

    Time frame: post-intervention

    The investigators measure upper limb function with a validated questionnaire (DASH) at the end of the intervention (through study completion, an average 15 days)

  7. Upper limb function after month with a validated questionnaire (DASH)

    Time frame: after month

    The investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2016
Registry last updated
Nov 21, 2017

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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