The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cervical
thoracic
exercises
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, manual therapy, respiratory function
Eligibility 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.
Sites / Locations
- Seval Tamer
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
cervical group
thoracic group
exercise group
Arm Description
cervical spinal mobilizations, exercises, 2 session for 6 weeks
cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks
exercises, 2 session for 6 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
pain position
pain level at rest, activity and night with visual analog scale (min 0cm-max10cm, better outcome 0 worst outcome 10)
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)
range of motion
neck range of motion(high degrees represent better outcome, low degrees represent worse outcome
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)
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
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)
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
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
kinesiophobia
tampa kinesiophobia scale (total score min 17-max 68 point, high degrees represent worse outcome, low degrees represent better outcome)
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.
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)
pressure pain
pressure pain tolerance with algometer (kg/cm2high degrees represent better outcome, low degrees represent worse outcome
respiratory muscle strenght
inspiratory muscle strength and expiratuary muscle strength will be measured with digital mouth pressure measuring device (%).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03447977
Brief Title
The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain
Official Title
The Effect of Manual Treatment on Respiratory Parameters, Pain, Posture and Quality of Life in Chronic Neck Pain Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 12, 2019 (Actual)
Study Completion Date
December 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, manual therapy, respiratory function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cervical group
Arm Type
Experimental
Arm Description
cervical spinal mobilizations, exercises, 2 session for 6 weeks
Arm Title
thoracic group
Arm Type
Experimental
Arm Description
cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks
Arm Title
exercise group
Arm Type
Experimental
Arm Description
exercises, 2 session for 6 weeks
Intervention Type
Other
Intervention Name(s)
cervical
Other Intervention Name(s)
cervical spine mobilization
Intervention Description
cervical spine manual therapy
Intervention Type
Other
Intervention Name(s)
thoracic
Other Intervention Name(s)
thoracic spine mobilizations
Intervention Description
thoracic spine manual therapy
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
exercises for pain
Primary Outcome Measure Information:
Title
respiratory function(forced vital capacity,peak expiratory flow,maximum voluntary ventilation,forced expiratory flow at 1sn)
Description
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
Secondary Outcome Measure Information:
Title
pain position
Description
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
Title
posture
Description
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
Title
range of motion
Description
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
Title
neck functional status
Description
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
Title
quality of life status
Description
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
Title
anxiety level
Description
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
Title
depression level
Description
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
Title
physical activity level
Description
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
Title
kinesiophobia
Description
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
Title
neck muscle endurance
Description
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
Title
neck and upper limb strengths test
Description
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
Title
pressure pain
Description
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
Title
respiratory muscle strenght
Description
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
Title
Thoracal expansion
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seval Tamer, Mcs
Organizational Affiliation
Hacettepe University Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seval Tamer
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
8 months after publication
IPD Sharing Access Criteria
requestors will be required to sign a data access agreement
Citations:
PubMed Identifier
24835338
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.
Results Reference
background
PubMed Identifier
17959320
Citation
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.
Results Reference
background
PubMed Identifier
25435700
Citation
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.
Results Reference
result
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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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