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Clinical Trials/TCTR20220722001
TCTR20220722001
Recruiting
Phase 1

Contralateral Transcutaneous electrical nerve stimulation (TENS) for phantom limb pain, A prospective randomized controlled trial (CTEP trial)

Mahidol University0 sites120 target enrollmentJuly 22, 2022
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ConditionsChronic phantom limb pain patientsContralateralTranscutaneous electrical nerve stimulation (TENS)phantom limb painrandomized controlled trial

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic phantom limb pain patients
Sponsor
Mahidol University
Enrollment
120
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 22, 2022
End Date
October 24, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Age more than 18 years.
  • •2\.Able to use the 0\-10 Numerical Rating Scale (NRS) to rate pain intensity.
  • •3\.Patient has phantom limb pain with an average intensity in the past week
  • •greater than equal 3 on a 0\-10 NRS.
  • •4\.Duration of phantom limb pain more than 3 months

Exclusion Criteria

  • •1\.Patients cannot understand or express themselves in Thai.
  • •2\.Serious psychiatric problem (such as schizophrenia or suicidal ideation with intent) that would interfere with study participation.
  • •3\.Contraindicated to receive TENS treatment (e.g., patient with a pace maker, patient spinal cord stimulation or LVAD).
  • •4\.Unable to apply TENS at the contralateral limb.
  • •5\.Other primary pain conditions or secondary pain associated with other diagnoses such as cancer or severe RLP (i.e., RLP with a greater average severity than PLP). However, although individuals with RLP that is greater in severity than PLP will be excluded from participating in the primary trial, these individuals may be enrolled in the study as RLP participants to pilot the effects of contralateral limb TENS in these individuals.

Outcomes

Primary Outcomes

Not specified

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