Diaphragmatic Breathing Training in Chronic Spinal Pain (NCT07539116) | Clinical Trial Compass
CompletedNot Applicable
Diaphragmatic Breathing Training in Chronic Spinal Pain
Greece183 participantsStarted 2024-10-25
Plain-language summary
The goal of this clinical trial is to learn whether adding breathing training to an exercise program can improve pain, mood, and thinking skills in adults with chronic spinal pain.
The main questions it aims to answer are:
* Does adding breathing training lower pain and its impact on daily life?
* Does it improve symptoms of anxiety and depression?
* Does it improve thinking skills, such as attention and mental flexibility?
Researchers will compare three groups to see if adding breathing training provides additional benefits:
* a group that performs exercise only
* a group that performs exercise combined with breathing training
* a group that receives general advice only
Participants will:
* take part in a 12-week program
* attend one supervised session each week
* complete two home-based (unsupervised) exercise sessions each week (about 30 minutes each)
Participants in the combined group will also:
* learn breathing techniques during supervised sessions using biofeedback (a method that provides real-time feedback on breathing patterns)
* practice breathing exercises at home four times per week (about 10 minutes each) without biofeedback support
Who can participate
Age range
18 Years – 72 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Medically confirmed diagnosis of chronic non-specific musculoskeletal pain of the spine (neck, upper back, or lower back)
* Pain lasting at least 12 weeks or recurring over time
* Medical clearance to safely participate in the study interventions
* No use of opioid medication during the month before enrollment
* Not currently participating in another physical or psychological treatment for spinal pain
* Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
* Acute spinal conditions (e.g., recent injury or inflammation)
* Neurological or severe neuromuscular disorders
* Clinically significant psychiatric disorders
* Active substance dependence
* Chronic respiratory disease
* Pregnancy
* Any medical condition that makes participation in the study interventions unsafe
* Insufficient ability to understand the Greek language
* Participation in another therapeutic intervention for spinal pain during the month before or at the time of enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity and pain-related interference
Timeframe: Baseline, post-intervention (12 weeks), and 4-week follow-up
2
Emotional status (anxiety and depression)
Timeframe: Baseline, post-intervention (12 weeks), and 4-week follow-up
3
Cognitive flexibility
Timeframe: Baseline, post-intervention (12 weeks), and 4-week follow-up