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Completed

NCT Number: NCT03447977

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

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seval Tamer

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

cervical

Other

cervical spine manual therapy

Other names: cervical spine mobilization

thoracic

Other

thoracic spine manual therapy

Other names: thoracic spine mobilizations

Exercises

Other

exercises for pain

Primary outcomes

  1. respiratory function(forced vital capacity,peak expiratory flow,maximum voluntary ventilation,forced expiratory flow at 1sn)

    Time frame: change from baseline respiratory parameters at six weeks

    respiratory function will be measured with spirometer (%)high degrees represent better outcome, low degrees represent worse outcome)

  2. respiratory muscle strength

    Time frame: change from baseline respiratory muscle strength at six weeks

    inspiratory muscle strength and expiratuary muscle strength will be measured with digital mouth pressure measuring device (%).

Secondary outcomes

  1. pain position

    Time frame: change from baseline pain at six weeks

    pain level at rest, activity and night with visual analog scale (min 0cm-max10cm, better outcome 0 worst outcome 10)

  2. posture

    Time frame: change from baseline posture at six weeks

    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)

  3. range of motion

    Time frame: change from baseline range of motion at six weeks

    neck range of motion(high degrees represent better outcome, low degrees represent worse outcome

  4. neck functional status

    Time frame: change from baseline functional status at six weeks

    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)

  5. quality of life status

    Time frame: change from baseline quality of life at six weeks

    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

  6. anxiety level

    Time frame: change from baseline anxiety level at six weeks

    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)

  7. depression level

    Time frame: change from baseline depression level at six weeks

    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

  8. physical activity level

    Time frame: change from baseline physical activity level at six weeks

    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

  9. kinesiophobia

    Time frame: change from baseline kinesiophobia at six weeks

    tampa kinesiophobia scale (total score min 17-max 68 point, high degrees represent worse outcome, low degrees represent better outcome)

  10. neck muscle endurance

    Time frame: change from muscle endurance baseline at six weeks

    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.

  11. neck and upper limb strengths test

    Time frame: change from baseline strength at six weeks

    neck and upper limb strengths test measured with dynamometer (high degrees represent better outcome, low degrees represent worse outcome)

  12. pressure pain

    Time frame: change from baseline strength at six weeks

    pressure pain tolerance with algometer (kg/cm2high degrees represent better outcome, low degrees represent worse outcome

  13. Thoracal expansion

    Time frame: change from baseline expansion strength at six weeks

    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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2018
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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