Neck Pain Clinical Trial
Official title:
The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain Individuals
NCT number | NCT03447977 |
Other study ID # | KA-17109 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 24, 2019 |
Verified date | June 2018 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 24, 2019 |
Est. primary completion date | October 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Individuals who have pain for at least 3 month with mechanical neck pain - Individuals voluntarily participating to the study Exclusion Criteria: - Individuals who have undergone cervical, spinal, thoracic or abdominal region surgeries, - Individuals whose pain is not due to mechanical reasons (patients whose disc pathology is not determined after the doctor's examination, patients without any neurological deficits or without motor loss included to study) - Positive cervical region instability and positive vertebral artery test - Individuals who have suffered whiplash injuries, osteoporosis or rheumatoid disease (such as rheumatoid arthritis, systemic lupus erythematosus, sjögren..) - Individuals who use cigarette - Individuals with bronchial asthma, chronic bronchitis, emphysema, bronchiectasis and malignancy) - Those whose body mass index is greater than 40 will not be taken into research. |
Country | Name | City | State |
---|---|---|---|
Turkey | Seval Tamer | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Hwangbo PN, Hwangbo G, Park J, Lee S. The Effect of Thoracic Joint Mobilization and Self-stretching Exercise on Pulmonary Functions of Patients with Chronic Neck Pain. J Phys Ther Sci. 2014 Nov;26(11):1783-6. doi: 10.1589/jpts.26.1783. Epub 2014 Nov 13. — View Citation
Kapreli E, Vourazanis E, Strimpakos N. Neck pain causes respiratory dysfunction. Med Hypotheses. 2008;70(5):1009-13. Epub 2007 Oct 23. — View Citation
Wirth B, Amstalden M, Perk M, Boutellier U, Humphreys BK. Respiratory dysfunction in patients with chronic neck pain - influence of thoracic spine and chest mobility. Man Ther. 2014 Oct;19(5):440-4. doi: 10.1016/j.math.2014.04.011. Epub 2014 Apr 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | change from baseline respiratory parameters at six weeks | |
Secondary | pain position | pain level at rest, activity and night with visual analog scale (min 0cm-max10cm, better outcome 0 worst outcome 10) | change from baseline pain at six weeks | |
Secondary | 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) | change from baseline posture at six weeks | |
Secondary | range of motion | neck range of motion(high degrees represent better outcome, low degrees represent worse outcome | change from baseline range of motion at six weeks | |
Secondary | 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) | change from baseline functional status at six weeks | |
Secondary | 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 | change from baseline quality of life at six weeks | |
Secondary | 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) | change from baseline anxiety level at six weeks | |
Secondary | 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 | change from baseline depression level at six weeks | |
Secondary | 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 | change from baseline physical activity level at six weeks | |
Secondary | kinesiophobia | tampa kinesiophobia scale (total score min 17-max 68 point, high degrees represent worse outcome, low degrees represent better outcome) | change from baseline kinesiophobia at six weeks | |
Secondary | 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. | change from muscle endurance baseline at six weeks | |
Secondary | 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) | change from baseline strength at six weeks | |
Secondary | pressure pain | pressure pain tolerance with algometer (kg/cm2high degrees represent better outcome, low degrees represent worse outcome | change from baseline strength at six weeks | |
Secondary | respiratory muscle strenght | inspiratory muscle strength and expiratuary muscle strength will be measured with digital mouth pressure measuring device (%). | change from baseline respiratory muscle strength at six weeks | |
Secondary | 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 | change from baseline expansion strength at six weeks |
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