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

Phase 1

Recruiting

• Conditions: Chronic phantom limb pain patients; Contralateral; Transcutaneous electrical nerve stimulation (TENS); phantom limb pain; randomized controlled trial

• Registration Number: TCTR20220722001
• Lead Sponsor: Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-22
• Study Completion: 2023-10-24
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified