Clinical trial NCT01789645: Physical Therapy in Carpal Tunnel Syndrome
Official title: Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal tunnel
Physical therapy
Surgery
Efficacy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Fundación Alcorcón
First posted: 2013-02-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the intensity of pain symptoms between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention
Secondary outcomes:
measure: Changes in patients self-perceived improvement between baseline and follow-up periods
timeFrame: Baseline and 1, 3, 6 and 12 months after the intervention
measure: Changes in function between baseline and follow-up periods
timeFrame: Baseline, and 1, 3, 6 and 12 months after intervention
measure: Changes in severity of the symptoms between baseline and follow-up periods
timeFrame: Baseline, and 1, 3, 6 and 12 months after the intervention
Other outcomes:
measure: Changes in Health-related quality of life (economic analysis)
timeFrame: Baseline, and 1, 3, 6 and 12 months after the intervention
measure: Changes in the intensity of pain symptoms between baseline and 4 years follow-up (extended follow-up)
timeFrame: Baseline and 48 months after the intervention (extended follow-up)
measure: Changes in function and severity of symptoms between baseline and 4 years follow-up (extended follow-up)
timeFrame: Baseline and 48 months after the intervention (extended follow-up)
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: César Fernández-de-las-Peñas, PT, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liew BXW, de-la-Llave-Rincon AI, Scutari M, Arias-Buria JL, Cook CE, Cleland J, Fernandez-de-Las-Penas C. Do Short-Term Effects Predict Long-Term Improvements in Women Who Receive Manual Therapy or Surgery for Carpal Tunnel Syndrome? A Bayesian Network Analysis of a Randomized Clinical Trial. Phys Ther. 2022 Apr 1;102(4):pzac015. doi: 10.1093/ptj/pzac015.
citation: Fernandez-de-Las-Penas C, Arias-Buria JL, Cleland JA, Pareja JA, Plaza-Manzano G, Ortega-Santiago R. Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial. Phys Ther. 2020 Oct 30;100(11):1987-1996. doi: 10.1093/ptj/pzaa150.
citation: Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.