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

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ClinicalTrials.gov Identifier: NCT03447977
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
SEVAL TAMER, Hacettepe University

Brief 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.


Condition or disease Intervention/treatment Phase
Neck Pain Other: cervical Other: thoracic Other: exercises Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain Individuals
Estimated Study Start Date : March 11, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cervical group
cervical spinal mobilizations, exercises, 2 session for 6 weeks
Other: cervical
cervical spine manual therapy
Other Name: cervical spine mobilization

Other: exercises
exercises for pain

Experimental: thoracic group
cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks
Other: cervical
cervical spine manual therapy
Other Name: cervical spine mobilization

Other: thoracic
thoracic spine manual therapy
Other Name: thoracic spine mobilizations

Other: exercises
exercises for pain

Experimental: exercise group
exercises, 2 session for 6 weeks
Other: exercises
exercises for pain




Primary Outcome Measures :
  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)


Secondary Outcome Measures :
  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. respiratory muscle strenght [ 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 (%).

  14. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447977


Contacts
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Contact: Seval Tamer, Mcs 095068654268 sevaltamer@hotmail.com

Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Seval Tamer, Mcs Hacettepe University Physiotherapy and Rehabilitation

Publications of Results:
Other Publications:
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Responsible Party: SEVAL TAMER, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03447977     History of Changes
Other Study ID Numbers: KA-17109
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 8 months after publication
Access Criteria: requestors will be required to sign a data access agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SEVAL TAMER, Hacettepe University:
neck pain
manual therapy
respiratory function

Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms