An interventional study of Actual Diacutaneous Fibrolysis and Sham Diacutaneous Fibrolysis in Carpal Tunnel Syndrome, sponsored by Universidad de Zaragoza. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
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
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.
605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 457 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Universidad de Zaragoza is the lead sponsor of 111 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Actual Diacutaneous Fibrolysis
Other: Actual Diacutaneous Fibrolysis
Sham Diacutaneous Fibrolysis
Other: Sham 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 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
Intensity symptoms pre-intervention with a visual analogic scale
The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Time frame: 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)
Time frame: 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.
Time frame: after month
Upper limb function pre-intervention with a validated questionnaire (DASH)
The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
Time frame: pre-intervention
Mechanosensitivity of median nerve pre-intervention with neurodynamic test
The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
Time frame: 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).
Time frame: post-intervention
Neurophysiological test pre-intervention
The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: after month
Plan to share: No — The patient data were confidential and were assigned a number to each patient to maintain confidentiality
No publications or documents are linked to this record.
The record gives a start of Apr 2016, a primary completion of Sep 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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