An interventional study of cervical and thoracic in Neck Pain, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
Neck pain which is common musculoskeletal system problem in all populations, negatively affects functional status and quality of life. Muscle spasms, postural problems in cervical and thoracic regions and impairment on respiratory parameters (respiratory functions and respiratory muscle strength) is seen with neck pain. Manual therapy and exercise are widely preferred in the treatment of neck pain for improve pain, posture, muscle strength, range of motion, functional status and quality of life.
There are some studies showing that manual therapy improves respiratory parameters in pulmonary diseases but studies are lacking for neck pain. Our aim is to indicate that effects of manual therapy, manual therapy for different regions (cervical and/or thoracal region) and exercises for pain, posture, quality of life and also respiratory parameters in patients with chronic neck pain.
Manual therapy and exercises are evidence-based methods for improving pain, muscle strength, range of motion, function and quality of life in individuals with neck pain. These physiotherapy approaches have been shown to improve respiratory functions in patients with neck pain and also in pulmonary diseases such as cystic fibrosis and chronic obstructive pulmonary diseases.
Studies show that to improve respiratory parameters in patients for chronic neck pain, mobilization of thoracic region and exercises for endurance of deep neck muscles are beneficial. Despite the proposal given in this study, there are few studies evaluating the relationship between respiratory functions and the strength of respiratory muscles in patients with neck pain in detail, and also the effectiveness of different physiotherapy-rehabilitation methods on respiratory functions on neck pain. In a single study on this subject, thoracic region manual therapy, stretching exercise program and both of these applications were applied for the subjects. At the end of the treatment, respiratory functions developed in all three groups; but both applications group have been shown to more effective than thoracic manual therapy group for increasing respiratory functions.Exercises and manual therapy for cervical and/or thoracic region frequently used for chronic neck pain but there are no studies that compare manual therapy for different region on respiratory parameters. Therefore, our aim is to determine the effects of exercises with manual therapy methods for cervical and/or thoracic region in chronic neck pain patients on pain, posture, quality of life, as well as on respiratory parameters.
Exclusion Criteria:
cervical spinal mobilizations, exercises, 2 session for 6 weeks
Other: cervical · Other: exercises
cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks
Other: cervical · Other: thoracic · Other: exercises
exercises, 2 session for 6 weeks
Other: exercises
cervical spine manual therapy
Also known as: cervical spine mobilization
thoracic spine manual therapy
Also known as: thoracic spine mobilizations
exercises for pain
respiratory function(forced vital capacity,peak expiratory flow,maximum voluntary ventilation,forced expiratory flow at 1sn)
respiratory function will be measured with spirometer (%)high degrees represent better outcome, low degrees represent worse outcome)
Time frame: change from baseline respiratory parameters at six weeks
respiratory muscle strength
inspiratory muscle strength and expiratuary muscle strength will be measured with digital mouth pressure measuring device (%).
Time frame: change from baseline respiratory muscle strength at six weeks
pain position
pain level at rest, activity and night with visual analog scale (min 0cm-max10cm, better outcome 0 worst outcome 10)
Time frame: change from baseline pain at six weeks
posture
forward head posture(high degrees represent worse outcome, low degrees represent better outcome), thoracic posture (high degrees represent worse outcome, low degrees represent better outcome)
Time frame: change from baseline posture at six weeks
range of motion
neck range of motion(high degrees represent better outcome, low degrees represent worse outcome
Time frame: change from baseline range of motion at six weeks
neck functional status
neck disability index (total score min 0- max 50 point, high degrees represent worse outcome, low degrees represent better outcome and 0-4 point= no disability, 5-14 minimal disability, 15-24 moderate disability, 25-34 severe disability, 35-50 total functional disability)
Time frame: change from baseline functional status at six weeks
quality of life status
Short form of quality of life scale(SF-36)(total score 100 point min 0-max 100 point, high degrees represent better outcome, low degrees represent worse outcome
Time frame: change from baseline quality of life at six weeks
anxiety level
back anxiety scale(min 0-max 63 point, high degrees represent worse outcome, low degrees represent better outcome, total score 0-17 point shows minimal anxiety, 18-24 shows moderate anxiety, 30-63 shows severe anxiety status)
Time frame: change from baseline anxiety level at six weeks
depression level
back depression scale(min 0-max 63 point,high degrees represent worse outcome, low degrees represent better outcome, total score 0-9 shows minimal depression, 10-16 shows mild depression, 17-29 shows moderate depression, 30-63 shows severe depression status
Time frame: change from baseline depression level at six weeks
physical activity level
international physical activity score ( the metabolic equivalent (MET) value will be calculated and recorded by asking the time and frequency spent on sitting, walking, moderately severe activities and violent activities. The total physical activity value will be determined using the formula calculated by the patient's body weight, total score \< 600 MET-dk/week shows physically inactivity, 600-3000 MET-dk/week shows minimal active and \> 3000 MET-dk/week shows active
Time frame: change from baseline physical activity level at six weeks
kinesiophobia
tampa kinesiophobia scale (total score min 17-max 68 point, high degrees represent worse outcome, low degrees represent better outcome)
Time frame: change from baseline kinesiophobia at six weeks
neck muscle endurance
The measurements were performed from a crook lying position with a pressure biofeedback device (Stabilizer, Chattanooga, USA), which was placed behind participants' neck. The device was initially inflated to a baseline pressure of 20 mmHg. The participants had to successively perform 3 10-s holds of a head nodding action at each of the 5 pressure levels (22 mmHg, 24 mmHg, 26 mmHg, 28 mmHg and 30 mmHg). Participants' deep neck flexors were considered fatigued when pressure decrease at the pressure sensor, apparent activation of the superficial neck flexors or a jerky action during holding of the pressure level were observed.
Time frame: change from muscle endurance baseline at six weeks
neck and upper limb strengths test
neck and upper limb strengths test measured with dynamometer (high degrees represent better outcome, low degrees represent worse outcome)
Time frame: change from baseline strength at six weeks
pressure pain
pressure pain tolerance with algometer (kg/cm2high degrees represent better outcome, low degrees represent worse outcome
Time frame: change from baseline strength at six weeks
Thoracal expansion
the difference between the values obtained during deep inspiration and expiration will be determined by tape (cm),high degrees represent better outcome, low degrees represent worse outcome
Time frame: change from baseline expansion strength at six weeks
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Sap, Icf
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Hacettepe University