Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carpal Tunnel Syndrome
- Sponsor
- Universidad Rey Juan Carlos
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Changes in the intensity of pain symptoms between baseline and follow-up periods
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
César Fernández-de-las-Peñas
Professor
Universidad Rey Juan Carlos
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes in the intensity of pain symptoms between baseline and follow-up periods
Time Frame: 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 Outcomes
- Changes in patients self-perceived improvement between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention)
- Changes in function between baseline and follow-up periods(Baseline, and 1, 3, 6 and 12 months after intervention)
- Changes in severity of the symptoms between baseline and follow-up periods(Baseline, and 1, 3, 6 and 12 months after the intervention)