Pain in Complex Regional Pain Syndrome

NCT04667364 | Terminated

• 1 other identifier: CRPSprojekt
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• NRS pain score

  Change in the NRS pain score pre- and post TENS treatment compared with the MED group (controls)

  Pre- and 1 week post TENS

Secondary Outcomes (10)

• Mechanical pressure pain threshold

  Pre, retest and 1, 12 weeks post TENS

• Temporal summation

  Pre, retest and 1, 12 weeks post TENS

• Thermal sensitivity

  Pre, retest and 1, 12 weeks post TENS

• Conditioned pain modulation

  Pre, retest and 1, 12 weeks post TENS

• Use of Analgesics

  Pre and 1, 12 weeks post TENS

Study Arms (2)

Group MED

NO INTERVENTION

A group of participants that receives treatment as usual that consists of medicinal treatment, prescribed by a specialist doctor (Carsten Kock-Jensen, MD) from the CRPS clinic and will be monitored using patients' medicinal records.

Group TENS

EXPERIMENTAL

A group of participants that receives transcutaneous electrical nerve stimulation (TENS) which is an inexpensive, noninvasive and safe treatment for pain.

Device: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

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.

Group TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CRPS according to existing diagnostic criteria
• Numeric Rating Scale (NRS) pain \>4

You may not qualify if:

• Prior use of TENS for the past 6 months
• Active inflammatory conditions
• Pacemaker
• Comorbid disease that could cause neuropathic pain such as diabetic neuropathy
• Significant cognitive deficits
• Chronic pain syndrome (e.g. fibromyalgia, phantom pain, rheumatoid arthritis)

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Hospital of Southwest Jutland

Esbjerg, Region Syddanmark, 6700, Denmark

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Bibi (Valgerdur) Gram, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  STUDY DIRECTOR

• Carsten Kock-Jensen, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  STUDY DIRECTOR

• Niels-Peter B Nielsen, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 14, 2020
• Study Start: February 25, 2021
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

DK (1)