Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Sham Diacutaneous Fibrolysis; Other: Actual Diacutaneous Fibrolysis

• Registration Number: NCT02698085
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-03
• Study Start: 2016-04-01
• Primary Completion: 2016-09-01
• Study Completion: 2016-10-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-19
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Sham Diacutaneous Fibrolysis	Sham Diacutaneous Fibrolysis
Intervention Goup	Actual Diacutaneous Fibrolysis	Actual Diacutaneous Fibrolysis

Primary Outcome Measures

Name	Time	Method
Intensity symptoms pre-intervention with a visual analogic scale	pre-intervention	The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Intensity symptoms after month with a visual analogic scale	after month	The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.
Intensity symptoms post-intervention with a visual analogic scale	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)

Secondary Outcome Measures

Name	Time	Method
Upper limb function pre-intervention with a validated questionnaire (DASH)	pre-intervention	The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
Mechanosensitivity of median nerve pre-intervention with neurodynamic test	Pre-intervention	The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
Mechanosensitivity of median nerve post-intervention with neurodynamic test	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).
Neurophysiological test pre-intervention	pre-intervention	The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
Neurophysiological test post-intervention	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)
Upper limb function post-intervention with a validated questionnaire (DASH)	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)
Upper limb function after month with a validated questionnaire (DASH)	after month	The investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.

Trial Locations

Locations (1)

Sandra Jiménez; 🇪🇸 Zaragoza, Spain