Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

University of Zaragoza

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Actual Diacutaneous Fibrolysis; Other: Sham Diacutaneous Fibrolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02698085

C.I.PI14/00086

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention Goup

Experimental group

Description:

Actual Diacutaneous Fibrolysis

Treatment:

Other: Actual Diacutaneous Fibrolysis

Placebo Group

Sham Comparator group

Description:

Sham Diacutaneous Fibrolysis

Treatment:

Other: Sham Diacutaneous Fibrolysis