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Clinical Trials/NCT04246216
NCT04246216
Completed
Not Applicable

Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve for Carpal Tunnel Syndrome

Universidad Rey Juan Carlos1 site in 1 country70 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Universidad Rey Juan Carlos
Enrollment
70
Locations
1
Primary Endpoint
Changes in pain intensity between baseline and follow-up periods
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

There is evidence supporting that physical therapy interventions can be effective for the management of patients with CTS. No consensus on the best approach exist. It seems clear that the median nerve is affected in several ways (compression, inflammation, excursion) in carpal tunnel syndrome. Percutaneous Electrical Nerve Stimulation is a treatment approach consisting of the application of an electrical current throughout needling filaments placed close to the nerve, in this case the median nerve. The purpose of this clinical trial is to compare changes in function, symptom severity and the intensity of pain after the application of Percutaneous Electrical Nerve Stimulation vs. endoscopic surgery in women with CTS at short- and long-term follow-up periods.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
March 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

César Fernández-de-las-Peñas

Full proffessor

Universidad Rey Juan Carlos

Eligibility Criteria

Inclusion Criteria

  • pain and paresthesia in the median nerve distribution
  • 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, steroid injections or physical therapy intervention
  • multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
  • history of neck, shoulder, or upper limb trauma (whiplash);
  • history of any systemic disease causing CTS (eg, diabetes mellitus, thyroid disease);
  • history of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
  • pregnancy;

Outcomes

Primary Outcomes

Changes in pain intensity between baseline and follow-up periods

Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention.

An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week.

Secondary Outcomes

  • Changes in hand function between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention.)
  • Changes in patient self-perceived improvement between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention.)
  • Changes in severity between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention.)

Study Sites (1)

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