CompletedNot Applicable

Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome

Spain100 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT02219919

SponsorUniversidad Rey Juan Carlos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Carpal Tunnel Syndrome trials