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Effect of manual therapy and therapeutic exercises on pain, respiratory function in individuals with forward head posture: a randomized clinical trial

Status Approved

First Submitted Date

2017/04/05
Registered Date

2017/04/19
Last Updated Date

2017/04/17

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002315
Unique Protocol ID	2-1040781-AB-N-01-2016084HR
Public/Brief Title	Effectiveness of manual therapy versus deep cervical flexors exercise in individuals with forward head posture
Scientific Title	Effect of manual therapy and therapeutic exercises on pain, respiratory function in individuals with forward head posture: a randomized clinical trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2-1040781-AB-N-01-2016084HR
Approval Date	2016-11-21
Institutional Review Board Name	Sahmyook University Bioethics Committee
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	CHO JU CHUL
Title	chief
Telephone	+82-42-600-6708
Affiliation	Sahmyook University
Address	815, Hwarang-ro, Nowon-gu, Seoul, Korea
Contact Person for Public Queries
Name	CHO JU CHUL
Title	chief
Telephone	+82-42-600-6708
Affiliation	Sahmyook University
Address	815, Hwarang-ro, Nowon-gu, Seoul, Korea
Contact Person for Updating Information
Name	CHO JU CHUL
Title	chief
Telephone	+82-42-600-6708
Affiliation	Sahmyook University
Address	815, Hwarang-ro, Nowon-gu, Seoul, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2016-11-21 Actual
Target Number of Participant	30
Primary Completion Date	2016-11-30 , Actual
Study Completion Date	2016-12-04 , Actual
Name of Study	Sahmyook University
Recruitment Status	Completed
Date of First Enrollment	2016-11-21 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Sahmyook University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Sahmyook University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	1. Purpose of Research- Although there is a continuing literature on the reduction of neck pain and respiratory function due to forward head posture, the therapeutic basis of pain relief and respiratory function is still insufficient in posture correction through manual therapy and therapeutic exercise commonly used in clinical practice. 2. Background- In previous studies, stretching of the muscles and deep neck flexor exercise were applied as a treatment for the forward head posture. Recent literature review of acute and chronic neck disease has highlighted the importance of intervention, active exercise, and physical therapy combined with manual therapy and active exercise. 3. Hypothesis-Manual therapy is more effective in improving pain and respiration than deep neck flexor exercise in patients with forward head posture. 4. Clinical research plan-The period of this study is a total of 6 weeks, the evaluation before and after treatment was conducted after applying 10 times interventions for 4 weeks and follow-up revaluation was conducted after 2 weeks. Mobilization Group (n=15) performed upper cervical and upper thoracic segmental mobilization, Exercise Group (n=16) performed Cranio-cervical flexion exercise.

Study Summary Information

Lay Summary

1. Purpose of Research- Although there is a continuing literature on the reduction of neck pain and respiratory function due to forward head posture, the therapeutic basis of pain relief and respiratory function is still insufficient in posture correction through manual therapy and therapeutic exercise commonly used in clinical practice.
2. Background- In previous studies, stretching of the muscles and deep neck flexor exercise were applied as a treatment for the  forward head posture. Recent literature review of acute and chronic neck disease has highlighted the importance of intervention, active exercise, and physical therapy combined with manual therapy and active exercise.
3. Hypothesis-Manual therapy is more effective in improving pain and respiration than deep neck flexor exercise in patients with forward head posture.
4. Clinical research plan-The period of this study is a total of 6 weeks, the evaluation before and after treatment was conducted after applying 10 times interventions for 4 weeks and follow-up revaluation was conducted after 2 weeks. Mobilization Group (n=15) performed upper cervical and upper thoracic segmental mobilization, Exercise Group (n=16) performed Cranio-cervical flexion exercise.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase3
Intervention Model	Factorial
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	The period of this study is a total of 6 weeks, the evaluation before and after treatment was conducted after applying 10 times interventions for 4 weeks and follow-up revaluation was conducted after 2 weeks. Mobilization Group(experimental group) (n=15) performed upper cervical and upper thoracic segmental mobilization, Exercise Group (comparison group) (n=16) performed Cranio-cervical flexion exercise(deep neck flexor exercise).Following the baseline examination, the 32 participants were randomly assigned to the cervical spine group or thoracic spine group by selecting one of two cards from a box. The participants were not informed of the research hypothesis(Hypothesis that combination upper thoracic mobilization and mobility exercise will help to improve the correct posture), and the evaluator was blinded to the participants’ treatment group assignments. Every participant was instructed not to discuss treatment-related information with the other participants.
Number of Arms	2
Arm 1	Arm Label Mobilization Group
	Target Number of Participant 15
	Arm Type Experimental
	Arm Description The period of this study is a total of 6 weeks, the evaluation before and after treatment was conducted after applying 10 times interventions for 4 weeks and follow-up revaluation was conducted after 2 weeks. Mobilization Group (n=15) performed upper cervical and upper thoracic segmental mobilization.
Arm 2	Arm Label Exercise Group
	Target Number of Participant 15
	Arm Type Experimental
	Arm Description The period of this study is a total of 6 weeks, the evaluation before and after treatment was conducted after applying 10 times interventions for 4 weeks and follow-up revaluation was conducted after 2 weeks. Exercise Group (n=16) performed Cranio-cervical flexion exercise(deep neck flexor exercise).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M54.22)Cervicalgia, cervical region
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~29Year
	Description To be eligible for inclusion, patients had to present with a primary complaint of neck pain the age from 20 to 29, those who indicate the Forward head posture symptom, and to have a Numeric pain rating scale score of at least 20%.
Exclusion Criteria	Patients were excluded if they exhibited any red flags (eg, tumor, fracture, cancer), a diagnosis of cervical spinal stenosis, a history of whiplash injury within the past 3months, prior surgery to the cervical or thoracic spine, presented with positive neurologic signs consistent with nerve root compression.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	respiratory function
Timepoint	baseline, 4-week, 6-week
Secondary Outcome(s) 1
Outcome	Numeric Pain Rating Scale
Timepoint	baseline, 4-week, 6-week
Secondary Outcome(s) 2
Outcome	craniovertebral angle
Timepoint	baseline, 4-week, 6-week
Secondary Outcome(s) 3
Outcome	Global rating of change scale
Timepoint	baseline, 4-week, 6-week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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