Chronic Non-specific Low-Back PainNCT07539116
Diaphragmatic Breathing Training in Chronic Spinal Pain
A study testing Structured Exercise program and Diaphragmatic Breathing Training in people with Chronic Non-specific Low-Back Pain and Chronic Non-specific Neck Pain, run by Democritus University of Thrace at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Chronic Non-specific Low-Back Pain, Chronic Non-specific Neck Pain
- What is being tested?
- Structured Exercise program and Diaphragmatic Breathing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesGreece
- Study dates
- 25 Oct 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Private Practice
Heraklion, Crete
Democritus University of Thrace, Department of Physical Education and Sport Science
Komotini, Thrace
About this study
Official title: The Effect of Diaphragmatic Breathing Training on Pain, Emotional Status, and Cognitive Flexibility in Individuals With Chronic Spinal Pain
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:
Read more
- 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
Read the detailed description
This study examined the effects of a structured exercise program, with or without diaphragmatic breathing training, in adults with chronic non-specific musculoskeletal pain of the spine.
Chronic pain was defined as pain persisting for at least 12 weeks or recurring over a prolonged period. Non-specific musculoskeletal pain refers to pain that cannot be attributed to a specific underlying pathology, such as fracture, trauma, or systemic disease, and is not associated with conditions that require surgical treatment.
Participants were recruited from the general population through an open call distributed across academic, clinical, and occupational settings. Individuals who expressed interest were screened for eligibility according to predefined criteria.
Eligible participants were randomly assigned to one of three groups: an exercise-only group, a combined exercise and diaphragmatic breathing group, or a minimal intervention control group. All participants in the intervention groups followed a 12-week program that included supervised and home-based sessions.
The exercise program was designed to improve spinal mobility, functional movement, flexibility, and neuromuscular control through progressive, multi-planar exercises performed in seated and standing positions. The combined intervention group additionally received training in diaphragmatic breathing supported by biofeedback during supervised sessions and practiced breathing exercises independently at home.
The control group received psychoeducation and general recommendations for physical activity, including walking, stretching, and relaxation techniques.
Validated clinical, psychological, and neuropsychological measures were used to assess pain, emotional status, quality of life, cognitive performance, and behavioral responses. These measures were administered at baseline, after completion of the intervention, and at follow-up.
All procedures were conducted according to predefined protocols to ensure consistency across groups.
- Being tested
- Structured Exercise program, Diaphragmatic Breathing Training
- Keywords
- Diaphragmatic breathing, Cognitive flexibility, Quality of life, exercise intervention, pain management, treatment adherence
- Medical subject headings
- Agnosia, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise programBehavioural
A structured exercise program targeting spinal mobility, muscular strengthening, postural control, flexibility, and neuromuscular coordination. Exercises were performed in seated and standing positions and included multi-planar functional movements, stretching, and mobilization of joints and neural tissue. The program was delivered over 12 weeks with one supervised session per week and additional unsupervised home-based sessions.
Diaphragmatic Breathing TrainingBehavioural
A biofeedback-assisted breathing intervention involving slow, controlled diaphragmatic breathing with emphasis on nasal inhalation and prolonged exhalation. Breathing was guided by visual pacing to regulate rhythm and promote a target breathing rate. Training was delivered during supervised sessions and practiced independently at home throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Exercise-only intervention | Experimental | Participants followed a structured exercise program delivered in supervised and home-based (unsupervised) sessions over a 12-week period. Receives: Behavioral: Structured Exercise program |
| Combined Exercise and Diaphragmatic Breathing intervention | Experimental | Participants followed the same structured exercise program and additionally received diaphragmatic breathing training supported by biofeedback during supervised sessions. They also practiced diaphragmatic breathing independently at home, without biofeedback support or supervision. Receives: Behavioral: Structured Exercise program; Behavioral: Diaphragmatic Breathing Training |
| Minimal intervention control | No intervention | Participants received psychoeducation and general recommendations for physical activity, including walking, stretching, and relaxation techniques, without supervised sessions or participation in a structured intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity and pain-related interference
Pain intensity and interference were assessed using the Brief Pain Inventory - Short Form (BPI-SF). Pain severity and interference scores range from 0 to 10, with higher scores indicating greater pain and functional impact.
Measured: Baseline, post-intervention (12 weeks), and 4-week follow-up
Emotional status (anxiety and depression)
Emotional status was assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item instrument with two subscales (anxiety and depression), each item scored from 0 to 3, with higher scores indicating greater symptom severity.
Measured: Baseline, post-intervention (12 weeks), and 4-week follow-up
Cognitive flexibility
Cognitive flexibility was assessed using the Trail Making Test (Part A and Part B) and the Stroop Color-Word Test. Performance was evaluated based on completion time and interference indices, with higher completion times and greater interference indicating lower cognitive flexibility.
Measured: Baseline, post-intervention (12 weeks), and 4-week follow-up
Secondary outcomes (2)
Adherence to the intervention
Adherence was defined as the total time (in minutes) of home-based (unsupervised) practice, recorded prospectively by participants throughout the intervention period using standardized weekly logs. Participants documented the frequency, type, and duration of exercise and, where applicable, diaphragmatic breathing practice.
Measured: Throughout the 12-week intervention period
Quality of life (WHOQOL-BREF total and domain scores)
Quality of life was assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF), a 26-item instrument measuring physical, psychological, social, and environmental domains. Items are rated on a 5-point Likert scale, with higher scores indicating better perceived quality of life.
Measured: Baseline, post-intervention (12 weeks), and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start25 Oct 2024
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Low-Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of three parallel groups: an exercise-only group, a combined exercise and diaphragmatic breathing group, or a minimal intervention control group. The design allows comparison of the effects of exercise alone versus exercise combined with breathing training, as well as comparison with a minimal intervention condition.
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Collaborators
- University of Crete (School of Medicine), University General Hospital of Heraklion
- Responsible party
- Principal investigator, Anastasia Beneka, Democritus University of Thrace
- Investigators
- Anastasia Gr Beneka, PhD, Principal investigator, Democritus University of ThracePanagiotis G. Simos, PhD, Study director, University of Crete, School of Medicine, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539116
- Sponsor's protocol ID
- 15008/132
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to data protection regulations and confidentiality requirements
Publications
Vlastou K, Beneka A, Bebetsos E, Basta M, Tzagarakis C, Karademas E, Bouloukaki I, Trivizadakis D, Simos P. Illness Coherence, Exercise Adherence, and Patient-Reported Outcomes in Chronic Spinal Pain: A Moderated Mediation Analysis. Healthcare (Basel). 2026 Sep 3;14(17):2843. doi: 10.3390/healthcare14172843.
PubMed 42737000
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diaphragmatic Breathing Training on Pain, Emotional Status, and Cognitive Flexibility in Individuals With Chronic Spinal Pain
- ClinicalTrials.gov ID
- NCT07539116
- Acronym / sponsor ID
- 15008/132
- Keywords
- Diaphragmatic breathing, Cognitive flexibility, Quality of life, exercise intervention, pain management, treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Collaborators
- University of Crete (School of Medicine), University General Hospital of Heraklion
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study examined the effects of a structured exercise program, with or without diaphragmatic breathing training, in adults with chronic non-specific musculoskeletal pain of the spine.
Chronic pain was defined as pain persisting for at least 12 weeks or recurring over a prolonged period. Non-specific musculoskeletal pain refers to pain that cannot be attributed to a specific underlying pathology, such as fracture, trauma, or systemic disease, and is not associated with conditions that require surgical treatment.
Participants were recruited from the general population through an open call distributed across academic, clinical, and occupational settings. Individuals who expressed interest were screened for eligibility according to predefined criteria.
Eligible participants were randomly assigned to one of three groups: an exercise-only group, a combined exercise and diaphragmatic breathing group, or a minimal intervention control group. All participants in the intervention groups followed a 12-week program that included supervised and home-based sessions.
The exercise program was designed to improve spinal mobility, functional movement, flexibility, and neuromuscular control through progressive, multi-planar exercises performed in seated and standing positions. The combined intervention group additionally received training in diaphragmatic breathing supported by biofeedback during supervised sessions and practiced breathing exercises independently at home.
The control group received psychoeducation and general recommendations for physical activity, including walking, stretching, and relaxation techniques.
Validated clinical, psychological, and neuropsychological measures were used to assess pain, emotional status, quality of life, cognitive performance, and behavioral responses. These measures were administered at baseline, after completion of the intervention, and at follow-up.
All procedures were conducted according to predefined protocols to ensure consistency across groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups: an exercise-only group, a combined exercise and diaphragmatic breathing group, or a minimal intervention control group. The design allows comparison of the effects of exercise alone versus exercise combined with breathing training, as well as comparison with a minimal intervention condition.
| Arm | Type | Receives |
|---|---|---|
| Exercise-only intervention | Experimental | Behavioral: Structured Exercise programParticipants followed a structured exercise program delivered in supervised and home-based (unsupervised) sessions over a 12-week period. |
| Combined Exercise and Diaphragmatic Breathing intervention | Experimental | Behavioral: Structured Exercise program, Behavioral: Diaphragmatic Breathing TrainingParticipants followed the same structured exercise program and additionally received diaphragmatic breathing training supported by biofeedback during supervised sessions. They also practiced diaphragmatic breathing independently at home, without biofeedback support or supervision. |
| Minimal intervention control | No intervention | –Participants received psychoeducation and general recommendations for physical activity, including walking, stretching, and relaxation techniques, without supervised sessions or participation in a structured intervention program. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Acute spinal conditions (e.g., recent injury or inflammation)
- Neurological or severe neuromuscular disorders
- Clinically significant psychiatric disorders
- Active substance dependence
- Chronic respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Exercise programA structured exercise program targeting spinal mobility, muscular strengthening, postural control, flexibility, and neuromuscular coordination. Exercises were performed in seated and standing positions and included multi-planar functional movements, stretching, and mobilization of joints and neural tissue. The program was delivered over 12 weeks with one supervised session per week and additional unsupervised home-based sessions. | Behavioural | Combined Exercise and Diaphragmatic Breathing intervention, Exercise-only intervention |
| Diaphragmatic Breathing TrainingA biofeedback-assisted breathing intervention involving slow, controlled diaphragmatic breathing with emphasis on nasal inhalation and prolonged exhalation. Breathing was guided by visual pacing to regulate rhythm and promote a target breathing rate. Training was delivered during supervised sessions and practiced independently at home throughout the intervention period. | Behavioural | Combined Exercise and Diaphragmatic Breathing intervention |
Primary outcome
Pain intensity and pain-related interference
Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up
Pain intensity and interference were assessed using the Brief Pain Inventory - Short Form (BPI-SF). Pain severity and interference scores range from 0 to 10, with higher scores indicating greater pain and functional impact.
Emotional status (anxiety and depression)
Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up
Emotional status was assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item instrument with two subscales (anxiety and depression), each item scored from 0 to 3, with higher scores indicating greater symptom severity.
Cognitive flexibility
Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up
Cognitive flexibility was assessed using the Trail Making Test (Part A and Part B) and the Stroop Color-Word Test. Performance was evaluated based on completion time and interference indices, with higher completion times and greater interference indicating lower cognitive flexibility.
2 secondary outcomes
Adherence to the intervention
Time frame: Throughout the 12-week intervention period
Quality of life (WHOQOL-BREF total and domain scores)
Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 42737000Vlastou K, Beneka A, Bebetsos E, Basta M, Tzagarakis C, Karademas E, Bouloukaki I, Trivizadakis D, Simos P. Illness Coherence, Exercise Adherence, and Patient-Reported Outcomes in Chronic Spinal Pain: A Moderated Mediation Analysis. Healthcare (Basel). 2026 Sep 3;14(17):2843. doi: 10.3390/healthcare14172843.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to data protection regulations and confidentiality requirements
Related trials for Chronic Non-specific Low-Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Gr Beneka, PhD principal investigator
Democritus University of Thrace
Panagiotis G. Simos, PhD study director
University of Crete, School of Medicine, Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise program and Diaphragmatic Breathing Training in people with Chronic Non-specific Low-Back Pain and Chronic Non-specific Neck Pain, run by Democritus University of Thrace at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity and pain-related interference (time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07539116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.