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Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02698085
Enrollment
60
Registered
2016-03-03
Start date
2016-04-01
Completion date
2016-10-10
Last updated
2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome, physiotherapy, manual therapy

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.

Interventions

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 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

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intensity symptoms pre-intervention with a visual analogic scalepre-interventionThe investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Intensity symptoms post-intervention with a visual analogic scalepost-interventionThe 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)
Intensity symptoms after month with a visual analogic scaleafter monthThe investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.

Secondary

MeasureTime frameDescription
Neurophysiological test pre-interventionpre-interventionThe investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
Neurophysiological test post-interventionpost-interventionThe 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 pre-intervention with a validated questionnaire (DASH)pre-interventionThe investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
Upper limb function after month with a validated questionnaire (DASH)after monthThe investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.
Upper limb function post-intervention with a validated questionnaire (DASH)post-interventionThe investigators measure upper limb function with a validated questionnaire (DASH) at the end of the intervention (through study completion, an average 15 days)
Mechanosensitivity of median nerve pre-intervention with neurodynamic testPre-interventionThe investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
Mechanosensitivity of median nerve post-intervention with neurodynamic testpost-interventionThe investigators measure the mechanosensitivity of median nerve with neurodynamic test at the end of the intervention (through study completion, an average 15 days).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026