Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With 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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Actual Diacutaneous Fibrolysis; Other: Sham Diacutaneous Fibrolysis

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50010
    • Sandra Jiménez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb function pre-intervention with a validated questionnaire (DASH)	The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.	pre-intervention
Mechanosensitivity of median nerve pre-intervention with neurodynamic test	The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.	Pre-intervention
Mechanosensitivity of median nerve post-intervention with neurodynamic test	The investigators measure the mechanosensitivity of median nerve with neurodynamic test at the end of the intervention (through study completion, an average 15 days).	post-intervention
Neurophysiological test pre-intervention	The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline	pre-intervention
Neurophysiological test 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)	post-intervention
Upper limb function post-intervention with a validated questionnaire (DASH)	The investigators measure upper limb function with a validated questionnaire (DASH) at the end of the intervention (through study completion, an average 15 days)	post-intervention
Upper limb function after month with a validated questionnaire (DASH)	The investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.	after month

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Investigators: Principal Investigator: Sand J, Graduated, I

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 10, 2016

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 19, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; manual therapy; physiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: C.I.PI14/00086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patient data were confidential and were assigned a number to each patient to maintain confidentiality