Back to resultsPercutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PNE
Surgery for CTS
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, nerve compression syndrome, median nerve, physical therapy technique, percutaneous needle electrolysis
Eligibility Criteria
Inclusion Criteria:
- Over 18 years.
- CTS diagnosed by Electromyography (EMG)
- Symptoms of CTS + EMG
Exclusion Criteria:
- Difficulty expressing your feelings properly
- Unsurpassed fear of needles
- History of adverse reactions to needles
- Epilepsy and / or allergies to metals.
- Difficulty expressing your feelings properly
- Existence of diffuse peripheral neuropathy or cervical radiculopathy
- History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PNE group
Surgery group
Arm Description
Patients received 4 sessions, separated one week between them. The treatment consisted the application of a galvanic current through an acupuncture needle (0,30x30mm). The approach were performed with a transverse axis with a needle in plane, being superficial and deep interface of medium nerve the target tissue. The parameters will be 2 mA (milliamps), 10 seconds, 3 impacts (3: 3: 3).
Patients received surgery for median nerve release.
Outcomes
Primary Outcome Measures
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
Secondary Outcome Measures
Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale
Describe the symptoms of the hand and wrist (pointing to them in a drawing), and using scales of 1 to 5 (1= No difficulty to do it; 5= I can´t do it), measure the difficulty of performing certain activities (writing, buttoning, holding a book ...)
Change of pain level
Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be)
Change of Semmes Weinstein Mini monofilament kit
Contact threshold, to assess if there is a decrease in sensitivity
Change of the Hand Dynamometer
Hand grip force
Changes of the Muscles strength by Kendall´s scale
Muscular strength of Opponens pollicis and Abductors policies. Scale of 0 to 5 (0=No visible or palpable contraction; 5=Full ROM against gravity, maximum resistance)
Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)
12 questions self-administered. Assess quality of life, general health and well-being using scales of 1 to 5 (1= Ever; 5= Never)
Full Information
NCT ID
NCT04216147
First Posted
December 28, 2019
Last Updated
December 30, 2019
Sponsor
Universidad de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT04216147
Brief Title
Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
Official Title
Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare the effectiveness of Percutaneous Needle Electrolysis (PNE) versus surgical treatment in the treatment of Carpal Tunnel Syndrome (CTS).
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, nerve compression syndrome, median nerve, physical therapy technique, percutaneous needle electrolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PNE group
Arm Type
Experimental
Arm Description
Patients received 4 sessions, separated one week between them. The treatment consisted the application of a galvanic current through an acupuncture needle (0,30x30mm). The approach were performed with a transverse axis with a needle in plane, being superficial and deep interface of medium nerve the target tissue. The parameters will be 2 mA (milliamps), 10 seconds, 3 impacts (3: 3: 3).
Arm Title
Surgery group
Arm Type
Experimental
Arm Description
Patients received surgery for median nerve release.
Intervention Type
Other
Intervention Name(s)
PNE
Intervention Description
Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.
Intervention Type
Procedure
Intervention Name(s)
Surgery for CTS
Intervention Description
Median nerve release
Primary Outcome Measure Information:
Title
Changes of the Boston Questionnaire for Carpal Tunnel Syndrome
Description
11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Changes of the Clinical Symptoms Carpal Tunnel Syndrome Scale
Description
Describe the symptoms of the hand and wrist (pointing to them in a drawing), and using scales of 1 to 5 (1= No difficulty to do it; 5= I can´t do it), measure the difficulty of performing certain activities (writing, buttoning, holding a book ...)
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Title
Change of pain level
Description
Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be)
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Title
Change of Semmes Weinstein Mini monofilament kit
Description
Contact threshold, to assess if there is a decrease in sensitivity
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Title
Change of the Hand Dynamometer
Description
Hand grip force
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Title
Changes of the Muscles strength by Kendall´s scale
Description
Muscular strength of Opponens pollicis and Abductors policies. Scale of 0 to 5 (0=No visible or palpable contraction; 5=Full ROM against gravity, maximum resistance)
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Title
Changes of the SF-12 Questionnaire (Short Form 12 Questionnaire)
Description
12 questions self-administered. Assess quality of life, general health and well-being using scales of 1 to 5 (1= Ever; 5= Never)
Time Frame
Baseline and after treatments: 6 weeks, 3 months, 6 months and 12 months
Other Pre-specified Outcome Measures:
Title
Direct and indirect health cost measures
Description
Number of visits to the specialist, number of hospitalization days, number of physiotherapy sessions, prescribed medication, days of work absenteeism
Time Frame
12 months after treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years.
CTS diagnosed by Electromyography (EMG)
Symptoms of CTS + EMG
Exclusion Criteria:
Difficulty expressing your feelings properly
Unsurpassed fear of needles
History of adverse reactions to needles
Epilepsy and / or allergies to metals.
Difficulty expressing your feelings properly
Existence of diffuse peripheral neuropathy or cervical radiculopathy
History of potential concurrent cause of idiopathic CTS (such as diabetes, thyroid, chronic rheumatoid arthritis, renal failure with hemodialysis, pregnancy..)
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Percutaneous Needle Electrolysis Versus Surgery in the Treatment of Carpal Tunnel Syndrome
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