Diaphragmatic Breathing Training in Chronic Spinal Pain

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:

• 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

Study Overview

• Status: Completed
• Conditions: Chronic Non-specific Neck Pain; Chronic Non-specific Low-Back Pain
• Intervention / Treatment: Behavioral: Structured Exercise program; Behavioral: Diaphragmatic Breathing Training

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Crete
    • Heraklion, Crete, Greece
      • Private Practice
  • Thrace
    • Komotini, Thrace, Greece
      • Democritus University of Thrace, Department of Physical Education and Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise-only intervention; Participants followed a structured exercise program delivered in supervised and home-based (unsupervised) sessions over a 12-week period.	Behavioral: Structured 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.
Experimental: Combined Exercise and Diaphragmatic Breathing intervention; 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.	Behavioral: Structured 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.; Behavioral: Diaphragmatic 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.
No Intervention: Minimal intervention control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, post-intervention (12 weeks), and 4-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, post-intervention (12 weeks), and 4-week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semantic and Phonemic Verbal Fluency Performance	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.	Baseline, post-intervention (12 weeks), and 4-week follow-up
Nonverbal Reasoning Performance (WAIS-IV Matrix Reasoning)	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.	Baseline, post-intervention (12 weeks), and 4-week follow-up
Illness Perceptions (Illness Perception Questionnaire)	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.	Baseline, post-intervention (12 weeks), and 4-week follow-up
Coping Strategies (Brief COPE)	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.	Baseline, post-intervention (12 weeks), and 4-week follow-up

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Collaborators: University of Crete (School of Medicine); University Hospital of Heraklion (Department of Psychiatry)
• Investigators: Principal Investigator: Anastasia Gr Beneka, PhD, Democritus University of Thrace; Study Director: Panagiotis G. Simos, PhD, University of Crete, School of Medicine, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; exercise intervention; pain management; treatment adherence; Cognitive flexibility; Diaphragmatic breathing
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Agnosia; Treatment Adherence and Compliance
• Other Study ID Numbers: 15008/132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to data protection regulations and confidentiality requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No