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Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.

Primary Purpose

Carpal Tunnel Syndrome, Ibuprofen, Pain Management

Status
Unknown status
Phase
Phase 4
Locations
Venezuela
Study Type
Interventional
Intervention
Ibuprofen tablets
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 and Tinel signs.
  • 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, , deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy (or contraindication) to non steroidal anti inflammatory drugs (NSAID), 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

  • Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ibuprofen

Control group

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.

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 100-mm 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 millimeters from 0 (no pain) to the patient's marked rating.

Secondary Outcome Measures

Upper limb function
Assessed through the quick Quick Disabilities of the Arm, Shoulder and Hand questionary (QuickDASH), which is a shortened version of the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) 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

First Posted
March 29, 2020
Last Updated
March 29, 2020
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04328805
Brief Title
Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.
Official Title
Pain Reduction and Changes in Upper Limb Function Produced by Over the Counter Oral Ibuprofen Versus the Lack of Treatment, in Carpal Tunnel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

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 effect of an oral ibuprofen treatment will be compared to those produced 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 an oral ibuprofen pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. Effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Ibuprofen, Pain Management, Pain, Chronic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
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
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
Drug
Intervention Name(s)
Ibuprofen tablets
Other Intervention Name(s)
Advil
Intervention Description
oral tablet
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 100-mm 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 millimeters from 0 (no pain) to the patient's marked rating.
Time Frame
Changes from baseline (measured immediately before the application of each treatment) at 60 minutes after the application of treatment. Measures at baseline and after treatment will be performed 1 day a week during 4 weeks.
Secondary Outcome Measure Information:
Title
Upper limb function
Description
Assessed through the quick Quick Disabilities of the Arm, Shoulder and Hand questionary (QuickDASH), which is a shortened version of the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) 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), and at 60 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 and Tinel signs. 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, , deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy (or contraindication) to non steroidal anti inflammatory drugs (NSAID), 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 H Unda, PhD
Phone
0034982410289
Email
5299559@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Perez, MD
Organizational Affiliation
INSALUD
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández
City
San Diego
State/Province
Carabobo
ZIP/Postal Code
02006
Country
Venezuela

12. IPD Sharing Statement

Plan to Share IPD
No
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30810754
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Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.

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