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Online Self-management in Fibromyalgia - Trial NCT06322485

Access comprehensive clinical trial information for NCT06322485 through Pure Global AI's free database. This phase not specified trial is sponsored by Leiden University and is currently Completed. The study focuses on Fibromyalgia. Target enrollment is 70 participants.

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NCT06322485
Completed
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06322485
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Online Self-management in Fibromyalgia
An Online Self-management Intervention for Patients With Hand Fibromyalgia - a Randomized Controlled Trial

Study Focus

Fibromyalgia

Internet-based self-management intervention

Interventional

behavioral

Sponsor & Location

Leiden University

Leiden University Medical Center

Leiden, Netherlands

Timeline & Enrollment

N/A

Jan 25, 2017

Jan 26, 2021

70 participants

Primary Outcome

Change in pain coping

Summary

This study has been previously registered with the National Trial Registry (NTR6267) that has
 been cancelled. The registered trial has been automatically transferred to a new Landelijk
 Trial Register, which does not contain all correct information on the current study and
 where no corrections can be made. Hence, the current study has been registered again with
 ClinicalTrials.gov.
 
 The goal of this clinical trial is to study the effectiveness of an internet-based
 self-management intervention in adult patients with fibromyalgia. A randomized controlled
 trial (RCT) will be performed, in which 70 participants will be randomized to either the
 self-management intervention or a waitlist control condition (patients in the waitlist
 condition will receive the intervention after the intervention ends in the intervention
 group, i.e., after 6 months). The primary effect constitutes of the difference in change in
 pain coping between patients in the intervention and control condition from baseline to
 post-intervention. As secondary outcomes, a number of other psychological and physical
 outcome measures will be assessed (e.g., health-related quality of life, well-being, pain
 impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the
 quality of the therapeutic relationship will be measured.

ICD-10 Classifications

Fibromyalgia
Myalgia
Fibrothorax
Cervicalgia
Epidemic myalgia

Data Source

ClinicalTrials.gov

NCT06322485

Non-Device Trial