NCT03447977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2019

Completed
Last Updated

May 29, 2025

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

December 22, 2017

Last Update Submit

May 22, 2025

Conditions

Keywords

neck painmanual therapyrespiratory function

Outcome Measures

Primary Outcomes (2)

  • 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)

    change from baseline respiratory parameters at six weeks

  • respiratory muscle strength

    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

Secondary Outcomes (13)

  • pain position

    change from baseline pain at six weeks

  • posture

    change from baseline posture at six weeks

  • range of motion

    change from baseline range of motion at six weeks

  • neck functional status

    change from baseline functional status at six weeks

  • quality of life status

    change from baseline quality of life at six weeks

  • +8 more secondary outcomes

Study Arms (3)

cervical group

EXPERIMENTAL

cervical spinal mobilizations, exercises, 2 session for 6 weeks

Other: cervicalOther: exercises

thoracic group

EXPERIMENTAL

cervical and thoracic spinal mobilizations, exercises, 2 session for 6 weeks

Other: cervicalOther: thoracicOther: exercises

exercise group

EXPERIMENTAL

exercises, 2 session for 6 weeks

Other: exercises

Interventions

cervical spine manual therapy

Also known as: cervical spine mobilization
cervical groupthoracic group

thoracic spine manual therapy

Also known as: thoracic spine mobilizations
thoracic group

exercises for pain

cervical groupexercise groupthoracic group

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who have pain for at least 3 month with mechanical neck pain
  • Individuals voluntarily participating to the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seval Tamer

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 25435700BACKGROUND
  • 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.

    PMID: 24835338BACKGROUND
  • 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.

    PMID: 17959320BACKGROUND

MeSH Terms

Conditions

Neck PainRespiratory Aspiration

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seval Tamer, Mcs

    Hacettepe University Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2017

First Posted

February 27, 2018

Study Start

June 1, 2018

Primary Completion

October 12, 2019

Study Completion

December 24, 2019

Last Updated

May 29, 2025

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
8 months after publication
Access Criteria
requestors will be required to sign a data access agreement

Locations