Back to resultsPain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Venezuela
Study Type
Interventional
Intervention
Median nerve neural mobilization
Ibuprofen Arginine
Gabapentin
Sponsored by
About this trial
This is an interventional supportive care trial for Carpal Tunnel Syndrome focused on measuring Ibuprofen Arginine, Gabapentin, Median nerve neural mobilization, Physiotherapy, Pain management
Eligibility Criteria
Inclusion Criteria:
- Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
- Full understanding of written and spoken Spanish (language).
- Participants must freely consent to participate.
- The presence of positive Phalen an Tinel sings.
- The presence of carpal tunnel syndrome signs and symptoms
Exclusion Criteria:
- The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Sites / Locations
- Ciudad Hospitalaria Enrique TejeraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
Median nerve neural mobilization
Ibuprofen arginine
Gabapentin
Control group
Arm Description
Non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks.
Oral tablet pharmaceutical treatment. Participants will be treated with a maximum of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 4 weeks.
Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 1800 mg per day, subdivided in 3 intakes of 600 mg each 8 hours during a time lapse of 4 weeks.
Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available.
Outcomes
Primary Outcome Measures
Distal upper limb pain
Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 10-cm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in centimeters from 0 (no pain) to the patient's marked rating.
Secondary Outcome Measures
Upper limb function
Assessed through the QuickDASH questionary, which is a shortened version of the 30-item DASH (Disabilities of the Arm, Shoulder and Hand) instrument.The instrument administered to the participants will be a self-report questionnaire, that will rate the difficulty and interference of daily life on a 5 point Likert scale. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04025203
Brief Title
Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome
Official Title
Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Unda Solano
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
In the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.
Detailed Description
The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 4 different groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Ibuprofen Arginine, Gabapentin, Median nerve neural mobilization, Physiotherapy, Pain management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Median nerve neural mobilization
Arm Type
Experimental
Arm Description
Non pharmaceutical, non invasive, physiotherapy technique; which consists of a passive and repetitive upper limb movement that seeks to induced median nerve gliding and incursions against surrounding connective tissue. Subjects will be treated 5 days per week during a total time lapse of 4 weeks.
Arm Title
Ibuprofen arginine
Arm Type
Active Comparator
Arm Description
Oral tablet pharmaceutical treatment. Participants will be treated with a maximum of 1200 mg per day, subdivided in 3 intakes of 400 mg each 8 hours during a time lapse of 4 weeks.
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Oral capsule pharmaceutical treatment. Participants will be treated with a maximum of 1800 mg per day, subdivided in 3 intakes of 600 mg each 8 hours during a time lapse of 4 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Waiting list control group. Participants that belong to the no intervention arm will be assigned to a waiting list to receive treatment. The participants will not receive treatment for carpal tunnel syndrome during a time lapse of 4 weeks. After this period of time, participants will begin the best treatment available.
Intervention Type
Other
Intervention Name(s)
Median nerve neural mobilization
Intervention Description
Manual therapy maneuver performed in the upper limb.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen Arginine
Other Intervention Name(s)
Spedifen
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
oral capsules
Primary Outcome Measure Information:
Title
Distal upper limb pain
Description
Assessed through the visual analog scale (VAS). The VAS is a psychometric response scale. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.The VAS is the most frequently used method to assess pain intensity. The scale will be displayed as a horizontal 10-cm line labelled at each end by descriptors such as 'no pain' (the minimum and best outcome possible) and 'worse pain ever' (maximum and worst outcome possible). The participant will mark the line to indicate pain severity and it is simply quantified by measuring the distance in centimeters from 0 (no pain) to the patient's marked rating.
Time Frame
Changes from baseline (measured immediately before the application of each treatment) at 40 minutes after the application of treatment. Measures at baseline and after treatment will be performed 3 days a week during 4 weeks.
Secondary Outcome Measure Information:
Title
Upper limb function
Description
Assessed through the QuickDASH questionary, which is a shortened version of the 30-item DASH (Disabilities of the Arm, Shoulder and Hand) instrument.The instrument administered to the participants will be a self-report questionnaire, that will rate the difficulty and interference of daily life on a 5 point Likert scale. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Time Frame
Changes from baseline (measured immediately before the application of the first treatment) at 40 minutes after the application of the last treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
Full understanding of written and spoken Spanish (language).
Participants must freely consent to participate.
The presence of positive Phalen an Tinel sings.
The presence of carpal tunnel syndrome signs and symptoms
Exclusion Criteria:
The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Unda, PhD
Phone
0034695634680
Email
5299559@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Unda, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ciudad Hospitalaria Enrique Tejera
City
Valencia
State/Province
Carabobo
ZIP/Postal Code
2001
Country
Venezuela
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos A Perez, MD
Phone
00584144177932
Email
Dr.cperezt@gmail.com
First Name & Middle Initial & Last Name & Degree
Carlos A Perez, MD
First Name & Middle Initial & Last Name & Degree
Edgar J Sayago, PT
First Name & Middle Initial & Last Name & Degree
Marian V Montilla, PT
12. IPD Sharing Statement
Plan to Share IPD
No
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Pain Reduction and Changes in Upper Limb Function Produced by Different Treatments in Carpal Tunnel Syndrome
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