Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698085
• Other study ID #: C.I.PI14/00086
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: November 19, 2017
• Start date: April 1, 2016
• Est. completion date: October 10, 2016

Study information

• Verified date: November 2017
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 10, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Actual 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
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

Locations

Country	Name	City	State
Spain	Sandra Jiménez	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity symptoms pre-intervention with a visual analogic scale	The investigators measure the intensity of symptoms with a visual analogic scale at baseline.	pre-intervention
Primary	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)	post-intervention
Primary	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.	after month
Secondary	Upper limb function pre-intervention with a validated questionnaire (DASH)	The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.	pre-intervention
Secondary	Mechanosensitivity of median nerve pre-intervention with neurodynamic test	The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.	Pre-intervention
Secondary	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).	post-intervention
Secondary	Neurophysiological test pre-intervention	The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline	pre-intervention
Secondary	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)	post-intervention
Secondary	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)	post-intervention
Secondary	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.	after month