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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
cervical
cervical spine manual therapy
thoracic
thoracic spine manual therapy
exercises
exercises for pain

Locations

Country Name City State
Turkey Seval Tamer Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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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