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Completed

NCT Number: NCT07539116

Diaphragmatic Breathing Training in 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:

* 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

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Key information

Conditions

Chronic Non-specific Low-Back Pain Agnosia Behavior Chronic Non-specific Neck Pain Health Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Practice, Heraklion, Crete, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured exercise program

Behavioral

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 Training

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Adherence to the intervention

    Time frame: 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.

  2. Quality of life (WHOQOL-BREF total and domain scores)

    Time frame: 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.

Other outcomes

  1. Semantic and Phonemic Verbal Fluency Performance

    Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up

    Verbal fluency was assessed using semantic and phonemic fluency tasks. Performance was measured as the number of correct words generated within a fixed time interval, with higher scores indicating better verbal fluency and cognitive flexibility.

  2. Nonverbal Reasoning Performance (WAIS-IV Matrix Reasoning)

    Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up

    Nonverbal reasoning ability was assessed using the Matrix Reasoning subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV). Scores reflect abstract reasoning and problem-solving ability, with higher scores indicating better performance.

  3. Illness Perceptions (Illness Perception Questionnaire)

    Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up

    Illness perceptions were assessed using the Illness Perception Questionnaire (IPQ), which evaluates cognitive and emotional representations of illness. Higher scores reflect stronger or more negative illness-related beliefs, depending on the subscale.

  4. Coping Strategies (Brief COPE)

    Time frame: Baseline, post-intervention (12 weeks), and 4-week follow-up

    Coping strategies were assessed using the Brief COPE questionnaire. The instrument evaluates different coping responses to stress, with higher scores indicating greater use of specific coping strategies.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Collaborators

  • University General Hospital of Heraklion
  • University of Crete (School of Medicine)

Registry information

Official study title

The Effect of Diaphragmatic Breathing Training on Pain, Emotional Status, and Cognitive Flexibility in Individuals With Chronic Spinal Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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