Diaphragmatic Breathing Training in Chronic Spinal Pain

NCT07539116 | Completed

• 1 other identifier: 15008/132
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Non-specific Low-Back Pain; Chronic Non-specific Neck Pain

Keywords

Diaphragmatic breathing; Cognitive flexibility; Quality of life; exercise intervention; pain management; treatment adherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Adherence to the intervention

  Throughout the 12-week intervention period

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

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

Other Outcomes (4)

• Semantic and Phonemic Verbal Fluency Performance

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

• Nonverbal Reasoning Performance (WAIS-IV Matrix Reasoning)

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

• Illness Perceptions (Illness Perception Questionnaire)

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

Study Arms (3)

Exercise-only intervention

EXPERIMENTAL

Participants followed a structured exercise program delivered in supervised and home-based (unsupervised) sessions over a 12-week period.

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.

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.

Interventions

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.

Combined Exercise and Diaphragmatic Breathing intervention; Exercise-only intervention

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.

Combined Exercise and Diaphragmatic Breathing intervention

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead
• University of Crete (School of Medicine): collaborator
• University Hospital of Heraklion (Department of Psychiatry): collaborator

Study Sites (2)

Private Practice

Heraklion, Crete, Greece

Location

Democritus University of Thrace, Department of Physical Education and Sport Science

Komotini, Thrace, Greece

Location

MeSH Terms

Conditions

Agnosia; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Anastasia Gr Beneka, PhD

  Democritus University of Thrace

  PRINCIPAL INVESTIGATOR

• Panagiotis G. Simos, PhD

  University of Crete, School of Medicine, Department of Psychiatry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 20, 2026
• Study Start: October 25, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)