Chronic Non-specific Low-Back Pain, Chronic Non-specific Neck Pain
Conditions
Keywords
Diaphragmatic breathing, Cognitive flexibility, Quality of life, exercise intervention, pain management, treatment adherence
Brief 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
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.
Interventions
BEHAVIORALStructured Exercise program
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.
BEHAVIORALDiaphragmatic Breathing Training
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.
Sponsors
Democritus University of Thrace
University of Crete (School of Medicine)
University Hospital of Heraklion (Department of Psychiatry)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity and pain-related interference | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the intervention | Throughout the 12-week intervention period | 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. |
| Quality of life (WHOQOL-BREF total and domain scores) | Baseline, post-intervention (12 weeks), and 4-week follow-up | 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. |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORAnastasia Gr Beneka, PhD
Democritus University of Thrace
STUDY_DIRECTORPanagiotis G. Simos, PhD
University of Crete, School of Medicine, Department of Psychiatry
Outcome results
None listed