Clinical trial NCT02219919: Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
Official title: Changes in Nociceptive Gain Processing After Physical Therapy and Surgery in Carpal Tunnel Syndrome: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Pain
Sensitivity
Pain Thresholds
Sensitization
Physical Therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Fundación Alcorcón
name: Hospital San Carlos, Madrid
First posted: 2014-08-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in widespread pressure pain thresholds between baseline and follow-up periods
timeFrame: Baseline and 3, 6, 9 and 12 months after the intervention.
Secondary outcomes:
measure: Changes in heat and cold pain thresholds between baseline and follow-up periods
timeFrame: Baseline and 3, 6, 9 and 12 months after the intervention
measure: Changes in pain intensity between baseline and follow-ups periods
timeFrame: Baseline and 3, 6, 9 and 12 months after the intervention
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcon
state: Madrid
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: