Diacutaneous Fibrolysis on Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Actual Diacutaneous Fibrolysis
Sham Diacutaneous Fibrolysis
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, physiotherapy, manual therapy
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
Sites / Locations
- Sandra Jiménez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention Goup
Placebo Group
Arm Description
Actual Diacutaneous Fibrolysis
Sham Diacutaneous Fibrolysis
Outcomes
Primary Outcome Measures
Intensity symptoms pre-intervention with a visual analogic scale
The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
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)
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.
Secondary Outcome Measures
Upper limb function pre-intervention with a validated questionnaire (DASH)
The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
Mechanosensitivity of median nerve pre-intervention with neurodynamic test
The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
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).
Neurophysiological test pre-intervention
The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
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)
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)
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.
Full Information
NCT ID
NCT02698085
First Posted
February 3, 2016
Last Updated
November 19, 2017
Sponsor
Universidad de Zaragoza
1. Study Identification
Unique Protocol Identification Number
NCT02698085
Brief Title
Diacutaneous Fibrolysis on Carpal Tunnel Syndrome
Official Title
Effectiveness of Physiotherapy Treatment With Diacuteneous Fibrolysis in Patients With Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (undefined)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
October 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, physiotherapy, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Goup
Arm Type
Experimental
Arm Description
Actual Diacutaneous Fibrolysis
Arm Title
Placebo Group
Arm Type
Sham Comparator
Arm Description
Sham Diacutaneous Fibrolysis
Intervention Type
Other
Intervention Name(s)
Actual Diacutaneous Fibrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Diacutaneous Fibrolysis
Intervention Description
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
Primary Outcome Measure Information:
Title
Intensity symptoms pre-intervention with a visual analogic scale
Description
The investigators measure the intensity of symptoms with a visual analogic scale at baseline.
Time Frame
pre-intervention
Title
Intensity symptoms post-intervention with a visual analogic scale
Description
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
Title
Intensity symptoms after month with a visual analogic scale
Description
The investigators measure the intensity of symptoms with a visual analogic scale after month of post-intervention.
Time Frame
after month
Secondary Outcome Measure Information:
Title
Upper limb function pre-intervention with a validated questionnaire (DASH)
Description
The investigators measure upper limb function with a validated questionnaire (DASH), at baseline.
Time Frame
pre-intervention
Title
Mechanosensitivity of median nerve pre-intervention with neurodynamic test
Description
The investigators measure the mechanosensitivity of median nerve with neurodynamic test at baseline.
Time Frame
Pre-intervention
Title
Mechanosensitivity of median nerve post-intervention with neurodynamic test
Description
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
Title
Neurophysiological test pre-intervention
Description
The investigators measure the neurophysiological properties of median nerve with electroneurogram with the neural conduction velocity at baseline
Time Frame
pre-intervention
Title
Neurophysiological test post-intervention
Description
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
Title
Upper limb function post-intervention with a validated questionnaire (DASH)
Description
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
Title
Upper limb function after month with a validated questionnaire (DASH)
Description
The investigators measure upper limb function with a validated questionnaire (DASH) after a month post-intervention.
Time Frame
after month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sand J, Graduated
Organizational Affiliation
I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandra Jiménez
City
Zaragoza
ZIP/Postal Code
50010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The patient data were confidential and were assigned a number to each patient to maintain confidentiality
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Diacutaneous Fibrolysis on Carpal Tunnel Syndrome
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