- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447977
The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain
The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain Individuals
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Seval Tamer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cervical group
cervical spinal mobilizations, exercises, 2 session for 6 weeks
|
cervical spine manual therapy
Other Names:
exercises for pain
|
Experimental: thoracic group
cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks
|
cervical spine manual therapy
Other Names:
exercises for pain
thoracic spine manual therapy
Other Names:
|
Experimental: exercise group
exercises, 2 session for 6 weeks
|
exercises for pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
change from baseline respiratory parameters at six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
change from baseline pain at six weeks
|
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)
|
change from baseline posture at six weeks
|
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
|
change from baseline range of motion at six weeks
|
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)
|
change from baseline functional status at six weeks
|
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
|
change from baseline quality of life at six weeks
|
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)
|
change from baseline anxiety level at six weeks
|
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
|
change from baseline depression level at six weeks
|
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
|
change from baseline physical activity level at six weeks
|
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)
|
change from baseline kinesiophobia at six weeks
|
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.
|
change from muscle endurance baseline at six weeks
|
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)
|
change from baseline strength at six weeks
|
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
|
change from baseline strength at six weeks
|
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 (%).
|
change from baseline respiratory muscle strength at six weeks
|
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
|
change from baseline expansion strength at six weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seval Tamer, Mcs, Hacettepe University Physiotherapy and Rehabilitation
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-17109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
-
Dow University of Health SciencesCompletedMechanical Neck PainPakistan
-
Linnaeus UniversityHalmstad UniversityCompleted
-
Loma Linda UniversityCompletedNeck Pain, PosteriorUnited States
Clinical Trials on cervical
-
Shanghai University of Traditional Chinese MedicineTianjin University of Traditional Chinese MedicineUnknown
-
Cairo UniversityCompleted
-
Ochsner Health SystemNorthwell HealthTerminatedInduction of LaborUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
University of AmericasCompletedBruxism | Muscle DisorderChile
-
Universidad Rey Juan CarlosCompleted
-
Loma Linda UniversityCompleted
-
Orthofix Inc.TerminatedCervical Degenerative Disc DiseaseUnited States
-
Medtronic Spinal and BiologicsCompletedRadiculopathy | Myelopathy | Cervical Degenerative Disc DiseaseUnited States
-
University Hospital, BonnUnknownCervical Disc DisordersGermany