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Unravelling the Epigenetic Mechanisms of Exercise-induced Pain in Chronic Widespread Pain: DNA Methylation Regulation of the Brain-derived Neurotrophic Factor Expression and Its Modulation by Transcranial Direct Current Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Many people with chronic widespread pain (CWP) feel more pain and fatigue after exercise. This makes it hard to stay active. Unfortunately, the investigators do not fully understand why this happens and how to prevent it. The primary goal of this study is to explore the underlying genetic and epigenetic mechanisms of BDNF gene in response to exercise, and investigate if transcranial direct current stimulation (tDCS) during exercise works to improve worsening symptoms response to exercise in people with CWP. The investigators designed a randomized crossover study and will enroll 60 patients with CWP and 60 healthy controls. Participants will undergo 2 interventions in random order: 1) exercise + active tDCS, and 2) exercise + sham tDCS. Participants will visit the hospital twice with at least one week in between the visits.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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⁃ Patients

⁃ Participants in the patient group must meet all of the following criteria:

• Diagnosis of chronic widespread pain (CWP) or fibromyalgia;

• Age between 18 and 70 years old;

• Body mass index (BMI) ≤ 35;

• Widespread Pain Index (WPI) assessment: the WPI questionnaire (0-19 points) will be used to record the number and distribution of painful body sites. Participants will be classified as having CWP if pain is reported on both sides of the body, above and below the waist, and in the axial skeleton, with pain symptoms lasting ≥ 3 months;

• Stable medication use for at least 1 month prior to study entry.

⁃ Healthy control group

⁃ Participants in the healthy control group must meet all of the following criteria:

• Age between 18 and 70 years old;

• Body mass index (BMI) ≤ 35;

• No chronic conditions, such as chronic pain and diabetes.

Locations
Other Locations
Belgium
VUB
RECRUITING
Jette
Contact Information
Primary
Pain in Motion research group
huanyu.xiong@vub.be
+32 497783956
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Exercise + active tDCS + patients
Patient participants will receive one bout of submaximal aerobic exercise, along with a single session of active tDCS simultaneously.
Sham_comparator: Exercise + sham tDCS + patients
Patient participants will receive one bout of submaximal aerobic exercise, along with a single session of sham tDCS simultaneously.
Active_comparator: Exercise + active tDCS + healthy controls
healthy volunteer participants will receive one bout of submaximal aerobic exercise, along with a single session of active tDCS simultaneously.
Sham_comparator: Exercise + sham tDCS + healthy controls
healthy volunteer participants will receive one bout of submaximal aerobic exercise, along with a single session of sham tDCS simultaneously.
Related Therapeutic Areas
Sponsors
Leads: Vrije Universiteit Brussel

This content was sourced from clinicaltrials.gov