About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Active Cycle of Breathing Technique
Other interventionThe 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 interventionThe 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 interventionThe 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 interventionTraditional 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.
Treatment groups
Trial outcomes
Primary outcomes
Neck Disability
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.
Forced Expiratory Volume in 1 Second (FEV1)
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.
Forced Vital Capacity (FVC)
Forced vital capacity (FVC) will be assessed using a COSMED Pony FX spirometer according to ATS/ERS guidelines. FVC will be recorded in liters.
FEV1/FVC Ratio
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.
Sponsors and contacts
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Istanbul Topkapi University
Lead sponsor
Medipol University
Collaborator
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