Clinical trial NCT02698085: Diacutaneous Fibrolysis on Carpal Tunnel Syndrome
Official title: Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
physiotherapy
manual therapy
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Intensity symptoms pre-intervention with a visual analogic scale
timeFrame: pre-intervention
measure: Intensity symptoms post-intervention with a visual analogic scale
timeFrame: post-intervention
measure: Intensity symptoms after month with a visual analogic scale
timeFrame: after month
Secondary outcomes:
measure: Upper limb function pre-intervention with a validated questionnaire (DASH)
timeFrame: pre-intervention
measure: Mechanosensitivity of median nerve pre-intervention with neurodynamic test
timeFrame: Pre-intervention
measure: Mechanosensitivity of median nerve post-intervention with neurodynamic test
timeFrame: post-intervention
measure: Neurophysiological test pre-intervention
timeFrame: pre-intervention
measure: Neurophysiological test post-intervention
timeFrame: post-intervention
measure: Upper limb function post-intervention with a validated questionnaire (DASH)
timeFrame: post-intervention
measure: Upper limb function after month with a validated questionnaire (DASH)
timeFrame: after month
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Sandra Jiménez
Study officials:
affiliation: I
name: Sand J, Graduated
role: PRINCIPAL_INVESTIGATOR
References: