Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02219919
• Date of registration: 16/08/2014
• Prospective Registration: No
• Primary sponsor: Universidad Rey Juan Carlos
• Public title: Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
• Scientific title: Changes in Nociceptive Gain Processing After Physical Therapy and Surgery in Carpal Tunnel Syndrome: A Randomized Clinical Trial
• Date of first enrolment: August 2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02219919
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Carpal Tunnel Syndrome

Intervention(s)

Other: Physical Therapy Group

Other: Surgical Group

Primary Outcome(s)

Changes in widespread pressure pain thresholds between baseline and follow-up periods [Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention.]

Secondary Outcome(s)

Changes in heat and cold pain thresholds between baseline and follow-up periods [Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention]

Changes in pain intensity between baseline and follow-ups periods [Time Frame: Baseline and 3, 6, 9 and 12 months after the intervention]

Secondary ID(s)

HUFA-12/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital San Carlos, Madrid

Hospital Universitario Fundación Alcorcón