Comparison of Interventions in Patients With Carpal Tunnel Syndrome

Universidade Norte do Paraná

Status: Completed

Conditions: Carpal Tunnel Syndrome Bilateral; Carpal Tunnel Syndrome

Treatments: Behavioral: stretching physiotherapy; Behavioral: Myofascial therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04347746

sg01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Clinical group

Active Comparator group

Description:

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

Treatment:

Behavioral: Myofascial therapy

Behavioral: stretching physiotherapy

Surgical group

Active Comparator group

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.

Treatment:

Behavioral: Myofascial therapy

Behavioral: stretching physiotherapy