Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome

NCT02219919 | Completed DMC

• 1 other identifier: HUFA-12/14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Pain; Sensitivity; Pain Thresholds; Sensitization; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Changes in widespread pressure pain thresholds between baseline and follow-up periods

  Pressure pain thresholds over the median, ulnar and radial nerves, and over the cervical spine, the second metacarpal, and tibialis anterior muscles will be bilaterally assessed.

  Baseline and 3, 6, 9 and 12 months after the intervention.

Secondary Outcomes (2)

• Changes in heat and cold pain thresholds between baseline and follow-up periods

  Baseline and 3, 6, 9 and 12 months after the intervention

• Changes in pain intensity between baseline and follow-ups periods

  Baseline and 3, 6, 9 and 12 months after the intervention

Study Arms (2)

Physical Therapy Group

EXPERIMENTAL

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.

Other: Physical Therapy Group

Surgical Group

ACTIVE COMPARATOR

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.

Other: Surgical Group

Interventions

Surgical Group 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.

Surgical Group

Physical Therapy Group 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.

Physical Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Hospital Universitario Fundación Alcorcón: collaborator
• Hospital San Carlos, Madrid: collaborator

Study Sites (2)

Hospital Universitario Fundación Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain; Hypersensitivity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 19, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

ES (2)