Physical Therapy in Carpal Tunnel Syndrome

Universidad Rey Juan Carlos

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Conservative group; Procedure: Surgical group

Study type: Interventional

Funder types: Other

Identifiers

NCT01789645

PI01223

Details and patient eligibility

About

It is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and long-term follow-up periods. We hypothesized that proper physical therapy approach can be equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

Full description

Scientific evidence for the management of CTS has exhibited conflicting results. The Cochrane review concluded that surgical treatment relieves symptoms significantly better than splinting but further research is needed. A systematic review focused on physical therapy for the management of CTS included 6 studies and found weak to strong effect of neural gliding exercises. Recent studies have revealed complex nociceptive mechanisms involved in CTS which should be carefully considered during the management of these patients. Proper physical therapy interventions can modulate nociceptive processes found in CTS. We will perform a randomized clinical trial nested within a prospective cohort as our study design to determine if proper physical therapy approach targeted to modulate sensitization processes is equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms;
• increasing symptoms during night;
• Tinel sign;
• Phalen sign;
• self-reported hand strength deficits.
• Deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation

Exclusion criteria

• if any sensory/motor deficit in ulnar or radial nerve was present;
• previous interventions with surgery or steroid injections;
• multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia);
• history of neck, shoulder or arm trauma;
• history of a systemic disease causing CTS (e.g. diabetes mellitus, or thyroid disease);
• history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia);
• if the patient was actively involved with or seeking litigation at the time of the study;
• pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Conservative group

Experimental group

Description:

The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.

Treatment:

Other: Conservative group

Surgical group

Active Comparator group

Description:

The surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.

Treatment:

Procedure: Surgical group