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Pain in Complex Regional Pain Syndrome

NCT04667364 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-04-24

No results posted yet for this study

Summary

CRPS is a complex pain condition that usually develops in response to trauma and immobilization which is very painful and debilitating. There is no consensus about the underlying mechanisms which might be a combination of mentally and physically factors. At the moment, better diagnostic clarification and better pain relieving treatment is needed. The aim of this study is to investigate changes in the perception of pain in patients with Complex Regional Pain Syndrome (CRPS), and whether this perception can be affected by treatment with transcutaneous electrical nerve stimulation (TENS) on the painful area. The study will consist of two parts. One in which patients' perception of pain will be compared to the perception of pain in healthy controls. Another in which the included patients are randomly allocated into a group receiving medical treatment plus treatment with transcutaneous electrical nerve stimulation on the painful area or in a group receiving medical treatment as usual (MED).Patients will be evaluated four times. At the start of the study, immediately after treatment, and again at 6 and 12 months after treatment. The evaluation consists of an overall assessment of pain, response to standardized sensory stimuli, and questionnaires about quality of life, physical capacity and mentally/socially well-being.

Conditions

  • Complex Regional Pain Syndrome Type I

Interventions

DEVICE

Transcutaneous electrical nerve stimulation (TENS)

Conventional TENS will be performed using two electrodes placed on the involved extremity and with the following stimulation parameters; a frequency of 100 Hz, pulse duration 50-100 ms, and at an intensity gradually increased until the patient feels a strong, tolerable and non-painful sensation (18, 19). The intensity is incrementally increased based on patient feedback. Patients will receive guidelines on how to use the TENS device at home and will over a period of 30 days self-administer TENS as needed. Patients is to fill out a predefined schedule on paper each day to monitor dose.

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • Bibi (Valgerdur) Gram, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

  • Carsten Kock-Jensen, MD · Esbjerg Hospital - University Hospital of Southern Denmark

  • Niels-Peter B Nielsen, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2022-09-01
Completion
2023-01-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667364 on ClinicalTrials.gov