Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome

NCT ID: NCT02219919

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-05-31

Brief Summary

This randomized clinical trial will investigate changes in pain intensity and nociceptive gain processing after the application of either physical therapy or surgery in women with carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain intensity, widespread pressure pain sensitivity and segmental thermal changes after the application of a physical therapy program based on desensitization maneuvers of the central nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up periods. We hypothesize that the physical therapy intervention targeted to desensitization of the central nervous system is more effective than surgical intervention for modulating altered nociceptive gain processing in women with CTS.

Detailed Description

There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a complex pain syndrome including both peripheral and central sensitization mechanisms. In fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain processing. In addition, these sensitization processes seem to be independent of electro-diagnostic findings. Previous studies support the use of physical therapy and surgical interventions for the management of pain and disability in these patients. However, there is no evidence related to changes in nociceptive gain process after the application of any therapeutic intervention. Preliminary evidence suggests that manual therapies can modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized clinical trial to determine if manual therapies including desensitization maneuvers of the central nervous system are effective to decrease widespread pressure pain and thermal pain hypersensitivity in women with CTS.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Physical Therapy Group

The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.

Group Type: EXPERIMENTAL

Physical Therapy Group

Intervention Type: OTHER

The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.

Surgical Group

The surgical group will receive a 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.

Group Type: ACTIVE_COMPARATOR

Surgical Group

Intervention Type: OTHER

The surgical group will receive a 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.

Interventions

Surgical Group

The surgical group will receive a 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.

Intervention Type: OTHER

Physical Therapy Group

The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• pain and paresthesia in the median nerve distribution
• increasing symptoms during the night,
• positive Tinel sign,
• positive Phalen sign,
• symptoms had to have persisted for at least 6 months
• deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy

Exclusion Criteria

• any sensory/motor deficit related to the ulnar or radial nerve;
• older than 65 years of age;
• previous surgical intervention or steroid injections;
• multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
• history of neck, shoulder, or upper limb trauma (whiplash);
• history of a systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
• history of other medical conditions (eg, rheumatoid arthritis, fibromyalgia);
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role: collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role: collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

César Fernández-de-las-Peñas

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Fundación Alcorcon

Alcorcón, Madrid, Spain

Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Countries

Spain

Other Identifiers

HUFA-12/14

Identifier Type: -

Identifier Source: org_study_id