ClinicalTrials.gov
ClinicalTrials.gov Menu

Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02698085
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Sandra Jiménez, Universidad de Zaragoza

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


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Actual Diacutaneous Fibrolysis Other: Sham Diacutaneous Fibrolysis Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome
Study Start Date : April 1, 2016
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : October 10, 2016


Arm Intervention/treatment
Experimental: Intervention Goup
Actual Diacutaneous Fibrolysis
Other: Actual Diacutaneous Fibrolysis
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 Comparator: Placebo Group
Sham Diacutaneous Fibrolysis
Other: Sham Diacutaneous Fibrolysis
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT02698085


Locations
Spain
Sandra Jiménez
Zaragoza, Spain, 50010
Sponsors and Collaborators
Universidad de Zaragoza
Investigators
Principal Investigator: Sand J, Graduated I

Responsible Party: Sandra Jiménez, Principal investigator, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT02698085     History of Changes
Other Study ID Numbers: C.I.PI14/00086
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Keywords provided by Sandra Jiménez, Universidad de Zaragoza:
carpal tunnel syndrome
physiotherapy
manual therapy

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