Physical Therapy in Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Surgical group; Other: Conservative group

• Registration Number: NCT01789645
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Study Start: 2013-02-20
• Primary Completion: 2014-01-25
• Study Completion: 2019-01-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical group	Surgical group	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.
Conservative group	Conservative group	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.

Primary Outcome Measures

Name	Time	Method
Changes in the intensity of pain symptoms between baseline and follow-up periods	Baseline and 1, 3, 6 and 12 months after the intervention	A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week.

Secondary Outcome Measures

Name	Time	Method
Changes in patients self-perceived improvement between baseline and follow-up periods	Baseline and 1, 3, 6 and 12 months after the intervention	Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively.
Changes in function between baseline and follow-up periods	Baseline, and 1, 3, 6 and 12 months after intervention	The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.
Changes in severity of the symptoms between baseline and follow-up periods	Baseline, and 1, 3, 6 and 12 months after the intervention	The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.

Trial Locations

Locations (1)

Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon; 🇪🇸 Alcorcon, Madrid, Spain