Clinical trial NCT04347746: Comparison of Interventions in Patients With Carpal Tunnel Syndrome
Official title: Comparison of Interventions in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Carpal Tunnel Syndrome Bilateral
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline Visual analog scale at eight weeks
timeFrame: Change from baseline at 8 weeks
measure: Change from baseline Boston Questionnarie score at eight weeks
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Change from baseline Short-Form 6 Dimensions at eight weeks
timeFrame: Change from baseline at 8 weeks
measure: Change from baseline Hand strength test at eight weeks
timeFrame: Change from baseline at 8 weeks.
measure: Change from baseline Sensitivity tests at eigth weeks
timeFrame: Change from baseline at 8 weeks
measure: Change from baseline Manual skill score at eigth weeks
timeFrame: Change from baseline at 8 weeks
measure: Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.
timeFrame: Change from baseline at 8 weeks
measure: 3D Assessment of Hand Function for the right and left hand.
timeFrame: Day 0
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Unopar
state: Paraná
Study officials:
References: