Efficacy of systolic extinction training (set) in fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia; Nervous System Diseases

• Registration Number: ISRCTN12087003
• Lead Sponsor: niversity Hospital Giessen - Marburg

Brief Summary

2015 Protocol article in https://doi.org/10.4172/2327-5146.1000166 Thieme K, Malinowski R, Monbureau O, Gracely RH. Method of electrical stimulation triggered by cardiac cycle to facilitate the treatment of fibromyalgia and other chronic diseases - Systolic Extinction Training (SET) protocol. General Med 3: 6. 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29999252 analysis (added 06/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-22
• Study Completion: 2020-06-30
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

The inclusion criteria consist of:
1. Meeting ACR (American College of Rheumatology) criteria of FM
2. Pain for a period of at least 6 months
3. Married
4. Willingness of the spouse to participate
5. Ability to complete the questionnaires and understand the treatment components.

Further essential inclusion criteria for the proposed tailored study are:
6. Cardiac hypertensive stress reactivity
7. High level of pain behaviors
8. Catastrophizing
9. Solicitous spouse responses

Exclusion Criteria

The exclusion criteria consisted of:
1. Inflammatory rheumatologic diseases and any concurrent major disease such as cancer, diabetes, or kidney failure
2. Intake of beta-blocker (systematic), opioids, anti-depressants)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Clinical pain. Clinical Pain will be measured before, after, 6 and 12 months after therapy using two methods:<br> 1.1. using the visual analogue score (VAS) before and after psychophysiological experiment that we provide before, after, 6 and 12 months after therapy<br> 1.2. using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory (MPI) before, after, 6 and 12 months after therapy.<br> 2. Physical impairment. Physical impairment / interference will be measured by using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory (MPI) before, therapy and then 6 and 12 months after therapy.<br> 3. Affective distress (according to IMMPACT guidelines). Affective distress will be measured by using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory (MPI) before, after, 6 and 12 months after therapy.<br>