Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

NCT02698085 | Completed DMC

• 1 other identifier: C.I.PI14/00086
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; physiotherapy; manual therapy

Outcome Measures

Primary Outcomes (3)

• Intensity symptoms pre-intervention with a visual analogic scale

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

  pre-intervention

• Intensity symptoms post-intervention with a visual analogic scale

  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)

  post-intervention

• Intensity symptoms after month with a visual analogic scale

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

  after month

Secondary Outcomes (7)

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

  pre-intervention

• Mechanosensitivity of median nerve pre-intervention with neurodynamic test

  Pre-intervention

• Mechanosensitivity of median nerve post-intervention with neurodynamic test

  post-intervention

• Neurophysiological test pre-intervention

  pre-intervention

• Neurophysiological test post-intervention

  post-intervention

Study Arms (2)

Intervention Goup

EXPERIMENTAL

Actual Diacutaneous Fibrolysis

Other: Actual Diacutaneous Fibrolysis

Placebo Group

SHAM COMPARATOR

Sham Diacutaneous Fibrolysis

Other: Sham Diacutaneous Fibrolysis

Interventions

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.

Intervention Goup

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Sandra Jiménez

Zaragoza, 50010, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Sand J, Graduated

  I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: March 3, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 10, 2016
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)