Physical Therapy in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789645
• Other study ID #: PI01223
• Status: Completed
• Phase: N/A
• Start date: February 20, 2013
• Est. completion date: January 28, 2019

Study information

• Verified date: August 2019
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 28, 2019
• Est. primary completion date: January 25, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.

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.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon	Alcorcon	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos	Hospital Universitario Fundación Alcorcón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Health-related quality of life (economic analysis)	The paper-based five-level version of EuroQol-5D (EQ-5D-5L) was used.	Baseline, and 1, 3, 6 and 12 months after the intervention
Other	Changes in the intensity of pain symptoms between baseline and 4 years follow-up (extended follow-up)	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.	Baseline and 48 months after the intervention (extended follow-up)
Other	Changes in function and severity of symptoms between baseline and 4 years follow-up (extended follow-up)	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.	Baseline and 48 months after the intervention (extended follow-up)
Primary	Changes in the intensity of pain symptoms between baseline and follow-up periods	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.	Baseline and 1, 3, 6 and 12 months after the intervention
Secondary	Changes in patients self-perceived improvement between baseline and follow-up periods	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.	Baseline and 1, 3, 6 and 12 months after the intervention
Secondary	Changes in function between baseline and follow-up periods	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.	Baseline, and 1, 3, 6 and 12 months after intervention
Secondary	Changes in severity of the symptoms between baseline and follow-up periods	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.	Baseline, and 1, 3, 6 and 12 months after the intervention