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CompletedNCT03447977Updated May 29, 2025

The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain

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

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Neck Pain

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Keywords

  • neck pain
  • manual therapy
  • respiratory function
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Individuals who have pain for at least 3 month with mechanical neck pain
  • Individuals voluntarily participating to the study

Exclusion criteria

Exclusion Criteria:

  • Individuals who have undergone cervical, spinal, thoracic, or abdominal region surgeries or pathology; whiplash injury; neurological deficit; osteoporosis; rheumatological disease; pulmonary disease; pharmacological treatment; or malignancy; or have a body mass index (BMI) >40 or were smokers
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    cervical group

    cervical spinal mobilizations, exercises, 2 session for 6 weeks

    Other: cervical · Other: exercises

  • Experimental
    thoracic group

    cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks

    Other: cervical · Other: thoracic · Other: exercises

  • Experimental
    exercise group

    exercises, 2 session for 6 weeks

    Other: exercises

Interventions

  • Othercervical

    cervical spine manual therapy

    Also known as: cervical spine mobilization

  • Otherthoracic

    thoracic spine manual therapy

    Also known as: thoracic spine mobilizations

  • Otherexercises

    exercises for pain

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

06

Study locations

1 site
  • Seval Tamer
    Ankara, Turkey
07

References and documents

Publications

  • 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. PubMed 25435700 ↗
  • 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. PubMed 24835338 ↗
  • Kapreli E, Vourazanis E, Strimpakos N. Neck pain causes respiratory dysfunction. Med Hypotheses. 2008;70(5):1009-13. doi: 10.1016/j.mehy.2007.07.050. Epub 2007 Oct 23. PubMed 17959320 ↗

Individual participant data

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

08

Registry details

Key details

Study ID
NCT03447977
Lead sponsor
Hacettepe University
Responsible party
SEVAL TAMER (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Feb 27, 2018
Start date
Jun 1, 2018
Primary completion
Oct 12, 2019
Completion
Dec 24, 2019
Last update
May 29, 2025

Study contacts

Seval Tamer, Mcs
principal investigator · Hacettepe University Physiotherapy and Rehabilitation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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