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Trial record 6 of 22 for:    Open Studies | "Carpal Tunnel Syndrome"
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Physical Therapy in Carpal Tunnel Syndrome

This study is currently recruiting participants.
Verified February 2013 by Universidad Rey Juan Carlos
Sponsor:
Collaborator:
Hospital Universitario Fundación Alcorcón.
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier:
NCT01789645
First received: February 6, 2013
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Carpal Tunnel Syndrome
 Other: Conservative group
Procedure: Surgical group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Rey Juan Carlos:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Changes in patients self-perceived improvement between baseline and follow-up periods [ Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, and 1, 3, 6 and 12 months after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, and 1, 3, 6 and 12 months after the intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Other: 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.
Active Comparator: 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.
 Procedure: 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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789645

Contacts
Contact: Cesar Fernández-de-las-Peñas, PT, PhD, DMSc + 34 91 488 88 84 cesar.fernandez@urjc.es

Locations
Spain
Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon Recruiting
Alcorcon, Madrid, Spain, 28922
Principal Investigator: César Fernández-de-las-Peñas, PT, PhD, DMSc            
Sponsors and Collaborators
Universidad Rey Juan Carlos
Hospital Universitario Fundación Alcorcón.
Investigators
Principal Investigator: César Fernández-de-las-Peñas, PT, PhD, DMSc Universidad Rey Juan Carlos
  More Information

No publications provided

Responsible Party: César Fernández-de-las-Peñas, Professor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT01789645     History of Changes
Other Study ID Numbers: PI01223
Study First Received: February 6, 2013
Last Updated: February 12, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Rey Juan Carlos:
Carpal tunnel
Physical therapy
Surgery
Efficacy

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013