Carpal Tunnel Syndrome
Conditions
Keywords
Gabapentin, Pain management, Physiotherapy
Brief summary
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 Gabapentin and 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 Gabapentin and the absence of treatment, in subjects who suffer the signs and symptoms of 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 3 different groups.
Interventions
DRUGGabapentin oral capsules
Oral capsule pharmaceutical treatment.
Manual therapy maneuver performed in the upper limb.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 sign. * 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, metabolic neuropathy, obesity (body mass index over 30), participants who are not employed, 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, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distal upper limb pain | Changes from baseline (measured immediately before the application of the first treatment) and immediately after the application of the last treatment at 4 weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Upper limb function | Changes from baseline (measured immediately before the application of the first treatment), and at 40 minutes after the application of the last treatment. | 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). |
| Work Status at baseline | Measured immediately before the application of the first treatment | This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: Do you currently work? |
| Work Status post treatment | Measured immediatly after the application of the last treatment. | This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: Do you currently work? |
| Change in Work Task (Job Type) | Measured immediatly after the application of the last treatment. | This measure is performed through the employed participant (full-time or part-time) answering in a dichotomous manner (yes or no) the question: Did you change your job type or task? |
| Tampa Scale for Kinesiophobia-17 (TSK-17) | Changes from baseline (measured immediately before the application of the first treatment), and at 60 minutes after the application of the last treatment. | The Tampa Scale for Kinesiophobia-17 (TSK-17) is a 17-item questionnaire designed to assess the fear of movement and re-injury (kinesiophobia). Items are rated on a 4-point Likert scale (ranging from strongly disagree to strongly agree), yielding a total score that reflects the severity of pain-related fear avoidance beliefs. The standard total score range for the Tampa Scale for Kinesiophobia (TSK-17) is 17 to 68. It is calculated by summing 17 items, each scored 1-4, with four items reverse-scored. Higher scores indicate greater fear of movement; a score $\\ge 37$ suggests clinical kinesiophobia. |
Countries
Venezuela
Outcome results
None listed