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NCT Number: NCT07797530

The Effectiveness of Breathing Training in Subacute Neck Pain

The aim of this clinical study is to investigate the effectiveness of breathing training added to a standard physical therapy and exercise program in individuals with non-specific subacute neck pain. Specifically, the study will evaluate the effect of breathing training on functional loss due to neck pain and on respiratory function. The main questions it aims to answer are:

* Does breathing training reduce functional loss due to neck pain in participants? * Does breathing training improve respiratory function in participants?

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Key information

Conditions

Active Cycle of Breathing Technique Breathing Technique Neck Pain Neurologic Manifestations Non Specific Neck Pain Pain Pathological Conditions, Signs and Symptoms Progressive Muscle Relaxation Signs and Symptoms Subacute Cervical Pain

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Researchers will compare Active Cycle of Breathing Technique (ACBT) with Progressive Muscle Relaxation(PMR).

Participants will be randomly divided to two groups: a study group and a control group.

Both groups will receive traditional physical therapy five days a week for three weeks.

The study group will receive Active Cycle of Breathing Technique and exercise three days a week for six weeks, while the Control Group will receive Progressive Muscle Relaxation and exercise three days a week for six weeks.

Participants will:

  • Attend a total of 18 treatment sessions with a physiotherapist, 3 days a week for 6 weeks.
  • Perform home exercises twice daily.
  • Assessments will be conducted at the beginning of the study and after treatment at week 6.

The study will also evaluate changes in pain, posture, head position, muscle strength, joint position sense, anxiety and depression, severity of insomnia, and quality of life.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged 35-60 years, of either sex.
  • Ability to read, write, and understand Turkish.
  • Diagnosis of non-specific neck pain by a specialist physician.
  • Neck pain duration of ≥6 weeks and <12 weeks, with pain intensity of ≥3/10 on the Visual Analog Scale (VAS).

Exclusion criteria

  • Neck pain with an identified specific underlying cause, such as traumatic injury (e.g., fracture or dislocation), infection, tumor, significant nerve root or spinal cord compression, or systemic rheumatic/inflammatory disease.
  • Upper cervical symptoms, including dizziness or lightheadedness.
  • Diagnosed primary headache disorders, including migraine and tension-type headache.
  • Persistent night pain, severe muscle spasm, unexplained weight loss, daily headache, loss of consciousness, or confusion.
  • Cardiopulmonary or respiratory diseases.
  • Acute or chronic musculoskeletal pain in other body regions that may interfere with participation in the exercise program.
  • Major surgery within the previous 6 months.
  • Spinal, thoracic, or abdominal surgery within the previous 3 years.
  • Current smoking or alcohol use.
  • Physiotherapy or osteopathic treatment for the neck region within the previous 3 months.

Treatment and study plan

Active Cycle of Breathing Technique

Other

The patient will sit comfortably in a chair in a quiet environment, with shoulders relaxed, and will be instructed to perform deep, slow breathing with prolonged exhalation. The cycle will be: Breathing Control-Thoracic Expansion Exercise (TEE)-Breathing Control-Thoracic Expansion Exercise-Breathing Control-Bilateral Thoracic Expansion Exercise (BTEE)-Breathing Control. Each step will be repeated 3-5 times. During TEE and BTEE, proprioceptive tactile stimulation will be applied by resistance during inhalation. The application procedure will be taught in sessions 1 and 2. At home, the patient will place their own hand where the therapist normally places theirs. The program will be performed 3 days/week for 6 weeks, 15-20 minutes/session. Participants will also be instructed to perform the technique at home twice daily.

Active Comparator: Progressive Muscle Relaxation

Other

The patient will wear comfortable clothing and sit in a quiet environment. During Progressive Muscle Relaxation, the eyes will be closed and attention will be focused on the body, particularly on muscle tension and relaxation. The session will begin with deep breathing and relaxing music. During inhalation, each muscle group will be contracted for 5 seconds and relaxed for 10 seconds during exhalation, while other muscles remain relaxed. The technique will be applied in order to the hands, arms, face, neck, shoulders, chest, abdomen, back, hips, thighs, lower legs, and feet. At the end, all muscles will be contracted and relaxed together, and the relaxed position will be maintained for 2 minutes. The program will be performed 3 days/week for 6 weeks, 15-20 minutes/session.Participants will also be instructed to perform the technique at home twice daily.

exercise program

Other

The exercise program will include active range of motion (AROM), stretching, scapular stabilization, deep cervical muscle, and postural exercises.

During weeks 1-2, the exercises will be performed as 1 set, progressing to 2 sets in week 3.

From week 4, resistance will be added to selected exercises as appropriate. These exercises will be performed as 1 set during weeks 4-5 and 2 sets during week 6.

The program will be performed under the supervision of a physiotherapist 3 days per week for 6 weeks, for a total of 18 sessions, with each session lasting 15-20 minutes. Participants will also be instructed to perform the exercises at home twice daily.

traditional physiotherapy

Other

Traditional physiotherapy will consist of electrotherapy modalities, including hot pack, ultrasound, interferential current, and transcutaneous electrical nerve stimulation (TENS). Traditional physiotherapy will be provided 5 days per week for 3 weeks, with each treatment session lasting 45 minutes.

Primary outcomes

  1. Neck Disability

    Time frame: Change from baseline neck disability at week 6.

    Neck disability will be assessed using the Neck Disability Index (NDI). The total score ranges from 0 to 50, with higher scores indicating greater disability.

  2. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Change From Baseline in FEV1 at Week 6

    Forced expiratory volume in 1 second (FEV1) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. FEV1 will be recorded in liters.

  3. Forced Vital Capacity (FVC)

    Time frame: Change from baseline in FVC at week 6

    Forced vital capacity (FVC) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. FVC will be recorded in liters.

  4. FEV1/FVC Ratio

    Time frame: Change from baseline in FEV1/FVC ratio at week 6

    The FEV1/FVC ratio will be calculated from spirometric measurements obtained using a COSMED Pony FX spirometer according to ATS/ERS guidelines. The FEV1/FVC ratio will be expressed as a percentage.

  5. Peak Expiratory Flow Rate (PEFR)

    Time frame: Change from baseline in PEFR at week 6

    Peak expiratory flow rate (PEFR) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. PEFR will be recorded in liters per minute.

  6. Slow Vital Capacity (SVC)

    Time frame: Change from baseline in SVC at week 6

    Slow vital capacity (SVC) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. SVC will be recorded in liters.

  7. Respiratory Muscle Strength

    Time frame: Change from baseline respiratory muscle strength at week 6.

    Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP, cmH₂O) and maximal expiratory pressure (MEP, cmH₂O). MIP will be used to assess inspiratory muscle strength, whereas MEP will be used to assess expiratory muscle strength.

  8. Pain Intensity

    Time frame: Change from baseline pain intensity at week 6.

    Pain intensity will be assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark the point that represents their pain intensity, and the score will be recorded in centimeters.

  9. Muscle Strength

    Time frame: Change from baseline muscle strength at week 6.

    Muscle strength will be assessed using Manual Muscle Testing (MMT) according to the Medical Research Council (MRC) scale. Muscle strength is scored from 0 to 5, with higher scores indicating greater muscle strength.

  10. Cervical Range of Motion

    Time frame: Change from baseline cervical range of motion at week 6.

    Cervical range of motion will be assessed using a Bubble Inclinometer. Cervical flexion, extension, right and left rotation, and right and left lateral flexion will be measured in degrees.

  11. Cervical Proprioception

    Time frame: Change from baseline cervical proprioception at week 6.

    Cervical proprioception will be assessed using the Laser Pointer-Assisted Angle Reproduction Test. Joint position error will be recorded in degrees.

  12. Cervical Muscle Endurance

    Time frame: Change from baseline cervical muscle endurance at week 6.

    Cervical flexor and extensor muscle endurance will be assessed using neck flexor and extensor endurance tests. The time that participants can maintain the required test position will be measured with a stopwatch and recorded in seconds.

  13. Posture

    Time frame: Change from baseline posture at week 6.

    Posture will be assessed using the New York Posture Rating Test, which evaluates postural changes in 13 body regions. The total score ranges from 13 to 65, with higher scores indicating better posture.

  14. Forward Head Posture

    Time frame: Change from baseline forward head posture at week 6.

    Forward head posture will be assessed by measuring the craniovertebral angle (CVA), defined as the angle between a horizontal line and the line connecting the midpoint of the tragus of the ear to the C7 spinous process. The angle will be recorded in degrees.

  15. Chest Mobility

    Time frame: Change from baseline chest mobility at week 6.

    Chest mobility will be assessed using the Chest Expansion Test. Chest expansion will be determined as the difference between chest circumference at maximal inspiration and maximal expiration and recorded in centimeters.

  16. Anxiety and Depression

    Time frame: Change from baseline anxiety and depression at week 6.

    Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items, with 7 items assessing anxiety and 7 assessing depression. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity.

  17. Quality of Life Assessed by the SF-12

    Time frame: Change from baseline quality of life at week 6.

    Quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better quality of life.

  18. Insomnia Severity

    Time frame: Change from baseline insomnia severity at week 6.

    Insomnia severity will be assessed using the Insomnia Severity Index (ISI). The ISI consists of 7 items, each scored from 0 to 4. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.

Study contacts

Contact information is provided by the study sponsor or research team.

ibrahim ARAS, Study Principal Investigator

CONTACT

[email protected]

+90 5393475436

Sponsors and collaborators

Lead sponsor

Istanbul Topkapi University

Other

Collaborators

  • Medipol University

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 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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