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Comparison of Interventions in Patients With Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Bilateral

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
stretching physiotherapy
Myofascial therapy
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • bilateral idiopathic CTS above six months of symptomatology;
  • with clinical criteria and ENMG for indication of clinical or surgical treatment;
  • who have no history of gabapentin allergy.

Exclusion Criteria:

  • Individuals with CTS for other reasons, such as pregnancy, arthritis, hypothyroidism, diabetes mellitus, trauma, expansive tunnel damage, amyloids, sarcoidosis, multiple myeloma, and leukemia.
  • Individuals with conditions that can simulate CTS, such as carpometacarpal thumb arthritis, cervical radiculopathy mainly of the sixth cervical root level, radial flexor carpal tenosynovitis and central disorders such as multiple sclerosis and cerebral infarction.

Sites / Locations

  • Unopar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clinical group

Surgical group

Arm Description

Individuals with bilateral idiopathic CTS with clinical criteria and mild to moderate ENMG severity and symptom evolution time above six months.

Individuals with bilateral idiopathic CTS with clinical criteria and severe ENMG in at least one hand and symptom evolution time above six months. These will be submitted to surgery on the severe hand and if equal severity on both hands, the dominant hand will be operated, with the patient's consent.

Outcomes

Primary Outcome Measures

Change from baseline Visual analog scale at eight weeks
The visual analog scale will measure the patient's pain intensity. The scale goes from 0 to 10, with 10 being better.
Change from baseline Boston Questionnarie score at eight weeks
The Boston questionnaire assesses the symptoms and functions of patients with CTS, it is self-administered. The sensitivity scale goes from 11 to 55, the motor scale goes from 7 to 35, bigger is better.

Secondary Outcome Measures

Change from baseline Short-Form 6 Dimensions at eight weeks
The Short-Form 6 Dimensions (SF6) questionnaire will be used to measure the impact on global health status. The scale goes from 0 to 100, with 100 being better.
Change from baseline Hand strength test at eight weeks
The hand strength test will use the Jammar hydraulic handgrip diameter and the hydraulic Pinch Gauge Jamar hydraulic will be used to measure the force of the digital clamp and digital clamp.
Change from baseline Sensitivity tests at eigth weeks
The sensitivity tests will be evaluated with the Semmes-Weistein monofilaments on the distal digital pulp of the second and fifth fingers, the two-point discriminator Touch-Test on the distal digital pulp of the second and fifth fingers and the vibratory sensitivity with 30 and 259 hertz tuning fork over the distal interphalangeal joint of the second and fifth fingers.
Change from baseline Manual skill score at eigth weeks
Manual skill will be analyzed with the nine-pin box and manual skill panel
Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.
The BMHQ 12 items is an efficient and versatile result instrument, specific to manual disability and the quality of the therapeutic care employed. In addition, this questionnaire retains the psychometric properties of the original MHQ. The scale goes from 0 to 100, with 100 being better.
3D Assessment of Hand Function for the right and left hand.
3D assessement evaluates the hand in relation to pain, its function and its appearance from the perspective of the individual at the expense of the evaluation from the doctor's point of view.

Full Information

First Posted
February 19, 2020
Last Updated
November 24, 2020
Sponsor
Universidade Norte do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT04347746
Brief Title
Comparison of Interventions in Patients With Carpal Tunnel Syndrome
Official Title
Comparison of Interventions in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Norte do Paraná

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to compare two types of intervention (stretching and myofascial manipulation) in the treatment of individuals with bilateral idiopathic carpal tunnel syndrome. This comparison applies to two groups, the clinical group is composed of patients of mild or moderate degree, whereas the surgical group is composed of a patient with at least one hand in severe degree and interventions are made after surgery.
Detailed Description
Using clinical criteria and ENMG, individuals will be divided into a clinical group when they have a mild and / or moderate degree of involvement in the hands and a surgical group when the impairment intensity is severe in at least one hand. The individuals in the clinical group will be randomized into two groups, with one group starting with stretching and a second group starting with hook-assisted myofascial manipulation. After four weeks of initial therapy and one week of wash-out the assessment tests described above will be applied. The groups will be inverted, maintaining the duration and frequency of the previous stage of the proposed therapies. After four weeks with a week of wash-out the tests will be reapplied in order to evaluate the therapeutic response. Individuals with severe idiopathic CTS will undergo surgery using a standard open technique with local anesthesia and after four weeks, randomization will be made for postoperative treatment on both hands by stretching or myofascial manipulation in the same manner described for the clinical group. Questionnaires will be applied in order to understand the patient's symptoms, functions, pain and quality of life. In addition, tests will be used to assess hand strength, sensitivity and hand ability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Carpal Tunnel Syndrome Bilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical group
Arm Type
Active Comparator
Arm Description
Individuals with bilateral idiopathic CTS with clinical criteria and mild to moderate ENMG severity and symptom evolution time above six months.
Arm Title
Surgical group
Arm Type
Active Comparator
Arm Description
Individuals with bilateral idiopathic CTS with clinical criteria and severe ENMG in at least one hand and symptom evolution time above six months. These will be submitted to surgery on the severe hand and if equal severity on both hands, the dominant hand will be operated, with the patient's consent.
Intervention Type
Behavioral
Intervention Name(s)
stretching physiotherapy
Intervention Description
A booklet with images and a description of all movements to be performed during therapy will be offered to patients. The booklet illustrates the movements for stretching the upper limbs divided as follows: three movements for the neck, three movements for the arms and forearms and four movements for the hands. The therapy will be carried out twice a week at the Unopar research center, under the guidance of a physiotherapist trained in technique and supervision by a senior therapist. At the end of each movement, the individual is instructed to maintain the position for 40 seconds. Patients will be instructed to appear in comfortable clothes and the environment will have favorable conditions.
Intervention Type
Behavioral
Intervention Name(s)
Myofascial therapy
Intervention Description
Myofascial therapy will be performed on the upper limbs, pectoral and dorsal regions with the aid of hooks (instrument assisted soft-tissue mobilization). In the supine position, the pectoral muscles will be manipulated (infracromial, external, axillary-claviculopectoral fossa), biceps brachii (short head, long and forearm insertion), round pronator, anterior forearm musculature (compartment of the radial extensor of the long carpus and brevis, finger extensor and ulnar carpal extensor). In lateral decubitus the deltoid muscle in the anterior, middle and posterior portions. In the prone position, the trapezius muscle (in its cervical, scapular and nuchal insertions), scapular levator muscle, great dorsal muscle (in its lateral insertions) and triceps brachii muscle. The hook manipulation time is two minutes of execution for each muscle mentioned above, making a total time of each section of forty minutes. There will be two weekly sessions with an interval between forty-eight hours.
Primary Outcome Measure Information:
Title
Change from baseline Visual analog scale at eight weeks
Description
The visual analog scale will measure the patient's pain intensity. The scale goes from 0 to 10, with 10 being better.
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline Boston Questionnarie score at eight weeks
Description
The Boston questionnaire assesses the symptoms and functions of patients with CTS, it is self-administered. The sensitivity scale goes from 11 to 55, the motor scale goes from 7 to 35, bigger is better.
Time Frame
Change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Short-Form 6 Dimensions at eight weeks
Description
The Short-Form 6 Dimensions (SF6) questionnaire will be used to measure the impact on global health status. The scale goes from 0 to 100, with 100 being better.
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline Hand strength test at eight weeks
Description
The hand strength test will use the Jammar hydraulic handgrip diameter and the hydraulic Pinch Gauge Jamar hydraulic will be used to measure the force of the digital clamp and digital clamp.
Time Frame
Change from baseline at 8 weeks.
Title
Change from baseline Sensitivity tests at eigth weeks
Description
The sensitivity tests will be evaluated with the Semmes-Weistein monofilaments on the distal digital pulp of the second and fifth fingers, the two-point discriminator Touch-Test on the distal digital pulp of the second and fifth fingers and the vibratory sensitivity with 30 and 259 hertz tuning fork over the distal interphalangeal joint of the second and fifth fingers.
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline Manual skill score at eigth weeks
Description
Manual skill will be analyzed with the nine-pin box and manual skill panel
Time Frame
Change from baseline at 8 weeks
Title
Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.
Description
The BMHQ 12 items is an efficient and versatile result instrument, specific to manual disability and the quality of the therapeutic care employed. In addition, this questionnaire retains the psychometric properties of the original MHQ. The scale goes from 0 to 100, with 100 being better.
Time Frame
Change from baseline at 8 weeks
Title
3D Assessment of Hand Function for the right and left hand.
Description
3D assessement evaluates the hand in relation to pain, its function and its appearance from the perspective of the individual at the expense of the evaluation from the doctor's point of view.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: bilateral idiopathic CTS above six months of symptomatology; with clinical criteria and ENMG for indication of clinical or surgical treatment; who have no history of gabapentin allergy. Exclusion Criteria: Individuals with CTS for other reasons, such as pregnancy, arthritis, hypothyroidism, diabetes mellitus, trauma, expansive tunnel damage, amyloids, sarcoidosis, multiple myeloma, and leukemia. Individuals with conditions that can simulate CTS, such as carpometacarpal thumb arthritis, cervical radiculopathy mainly of the sixth cervical root level, radial flexor carpal tenosynovitis and central disorders such as multiple sclerosis and cerebral infarction.
Facility Information:
Facility Name
Unopar
City
Londrina
State/Province
Paraná
Country
Brazil

12. IPD Sharing Statement

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Comparison of Interventions in Patients With Carpal Tunnel Syndrome

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