Comparison of Interventions in Patients With Carpal Tunnel Syndrome

NCT04347746 | Completed

• 1 other identifier: sg01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Carpal Tunnel Syndrome Bilateral

Outcome Measures

Primary Outcomes (2)

• 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 at 8 weeks

• 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.

  Change from baseline at 8 weeks

Secondary Outcomes (6)

• Change from baseline Short-Form 6 Dimensions at eight weeks

  Change from baseline at 8 weeks

• Change from baseline Hand strength test at eight weeks

  Change from baseline at 8 weeks.

• Change from baseline Sensitivity tests at eigth weeks

  Change from baseline at 8 weeks

• Change from baseline Manual skill score at eigth weeks

  Change from baseline at 8 weeks

• Change from baseline Brief Michigan Hand Questionnaire for the right and left hand at eight weeks.

  Change from baseline at 8 weeks

Study Arms (2)

Clinical group

ACTIVE COMPARATOR

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

Behavioral: stretching physiotherapy; Behavioral: Myofascial therapy

Surgical group

ACTIVE COMPARATOR

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.

Behavioral: stretching physiotherapy; Behavioral: Myofascial therapy

Interventions

stretching physiotherapy BEHAVIORAL

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.

Clinical group; Surgical group

Myofascial therapy BEHAVIORAL

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.

Clinical group; Surgical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Unopar

Londrina, Paraná, Brazil

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: April 15, 2020
• Study Start: September 12, 2019
• Primary Completion: December 12, 2019
• Study Completion: June 12, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

BR (1)