• 1. background
CRIS Registration Number KCT0002307 
Unique Protocol ID 2-1040781-AB-N-01-2016083HR 
Public Title Thoracic Spine Nonthrust Mobilization and Mobility Exercise Versus Cervical Spine Nonthrust Mobilization and Stabilization Exercise in Patients With Forward Head Posture 
Scientific Title Thoracic Spine Nonthrust Mobilization and Mobility Exercise Versus Cervical Spine Nonthrust Mobilization and Stabilization Exercise in Patients 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
Approval Status Submitted approval 
Approval Number 2-1040781-AB-N-01-2016083HR 
Approval Date 2016-11-21 
Institutional Review Board
Name Sahmyook University Bioethics Committee 
Address  
Telephone  
Data Monitoring Committee No
  • 3. Contact Details
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. Study Status
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
Recruitment Status by Participating Study Site 1
Name of Study Site Sahmyook University 
Recruitment Status Completed  
Date of First Enrollment 2016-11-21 , Actual
  • 5. Source of Monetary / Material Support
Source of Monetary/Material Support 1
Organization Name Sahmyook University 
Organization Type  
Project ID  
  • 6. Sponsor Organization
Sponsor Organization 1
Organization Name Sahmyook University 
Organization Type University  
  • 7. Study Summary
Lay Summary 1. Purpose of Research-This study aimed to identify the effects of comparing pain and movement improvements as well as the correlation between the cervical and thoracic spine when patients with neck pain are treated with mobilization and therapeutic exercises. Although therapy in previous studies first focused on the cervical spine, this study aimed to identify the effect on pain and movement by comparing the thoracic (indirect) therapy and providing the basis of the therapeutic exercises for forward head posture.
2. background-. In patients with forward head posture, one of the most common posture-related disabilities, it is insufficient to identify the point at which the joint mobilization technique generally used in clinical practice recovers the thoracic mobility and then improves the cervical pain and the abnormal movement as well as confirm the therapeutic basis on the postural correction of the therapeutic exercise.
3. hypothesis-Upper thoracic joint mobilization and mobility exercise may be more effective for pain and function improvement than cervical joint mobilization and stabilization for forwardhead posture.
4. Clinical research plan-Recruit a forwardhead posture with neck pain.Experimental group 1 (cervical group) performed the upper cervical mobilization and cervical retraction exercise, and experimental group 2 (thoracic group) examined the effect of upper thoracic mobilization and upper thoracic extension exercise on pain and function improvement .  
  • 8. Study Design
Study Design
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase3 
Intervention Model Factorial
Blinding/Masking Single 
Blinding/Masking Subject 
Allocation RCT 
Intervention Type /Procedure/Surgery
Intervention Description The study period was 6 weeks long, and the pre- and post-treatment evaluation involved 10 interventions over 4 weeks and a follow-up re-evaluation was conducted after 2 weeks. Participants in experimental group 1 (cervical group) performed upper cervical segmental mobilization and cervical retraction exercises, while those in experimental group 2 (thoracic group) performed upper thoracic segmental mobilization and upper thoracic extension exercises.  
Number of Arms
Arm 1
Arm Label upper cervical segmental mobilization and cervical retraction exercisescervical group 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description The study period was 6 weeks long, and the pre- and post-treatment evaluation involved 10 interventions over 4 weeks and a follow-up re-evaluation was conducted after 2 weeks. Participants in experimental group 1 (cervical group) performed upper cervical segmental mobilization and cervical retraction exercises. 
Arm 2
Arm Label upper thoracic segmental mobilization and upper thoracic extension exercisesthoracic group  
Target Number of Participant 15 
Arm Type Experimental 
Arm Description The study period was 6 weeks long, and the pre- and post-treatment evaluation involved 10 interventions over 4 weeks and a follow-up re-evaluation was conducted after 2 weeks. Participants in experimental group 2 (thoracic group) performed upper thoracic segmental mobilization and upper thoracic extension exercises. 
  • 9. Subject Eligibility
Condition(s)/Problem(s) * Diseases of the musculo-skeletal system and connective tissue
 
Inclusion Criteria
Gender Both 
Age 20 Year ~ 29 Year 
Description To be eligible for inclusion, patients must present with a primary complaint of neck pain, be 20–29 years of age, report Forwardhead posture symptoms, and 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 3 months, prior surgery to the cervical or thoracic spine, or presented with positive neurologic signs consistent with nerve root compression.  
Healthy Volunteers No  
  • 10. Outcome Measure(s)
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1
Outcome craniovertebral angle  
Timepoint baseline, 4-week, 6-week 
Secondary Outcome(s) 1
Outcome Cervical range of motion  
Timepoint baseline, 4-week, 6-week 
Secondary Outcome(s) 2
Outcome Neck disability index  
Timepoint baseline, 4-week, 6-week 
Secondary Outcome(s) 3
Outcome Numeric pain rating scale  
Timepoint baseline, 4-week, 6-week 
Secondary Outcome(s) 4
Outcome Pressure pain threshold  
Timepoint baseline, 4-week, 6-week 
Secondary Outcome(s) 5
Outcome Global rating of change  
Timepoint baseline, 4-week, 6-week 
  • 11. Publication
Result Registerd  
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No