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

August 5, 2020 updated by: SEVAL TAMER, Hacettepe University

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Seval Tamer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Seval Tamer, Mcs, Hacettepe University Physiotherapy and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

October 12, 2019

Study Completion (Actual)

December 24, 2019

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-17109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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