Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy
Primary Purpose
Chronic Pain, Neck Pain, Shoulder Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gong's Mobilization
Gradually Graded Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Gong's Mobilization, Gradually graded exercise therapy
Eligibility Criteria
Inclusion Criteria:• Subjects with an age range of 15 to 65 years having Chronic neck pain for more than 3 months and subjects having a baseline NDI score of atleast 20% (10 points).
-
Exclusion Criteria:
• Cervical stenosis
- History of traumatic Injury
- Previous surgery related to cervical spine
- Hypermobility
- Cancer
- Inflammatory rheumatologic diseases
- Severe psychological disorders
- Being pregnant and
- Intervention including exercise or physical therapy in the last 3 months.
Sites / Locations
- Riphah International University
- Riphah IU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gong's Mobilization
Gradually Graded Exercise Therapy
Arm Description
Subjects received gong's mobilization three times in a week for 4 weeks.
Subjects received gradually graded exercise therapy three times in a week for 4 weeks.
Outcomes
Primary Outcome Measures
Change in Pain Intensity by 'Numeric Pain Rating Scale'
Change in pain from baseline was measured at 12th session. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by subject himself, under the supervision of researcher.
Change in Neck disability Index 'NDI' score
Change in Neck disability Index score 'NDI' from baseline was measured at 12th session. This questionnaire or tool has been designed to give us information as to how neck pain of the subject has affected his/her ability to manage in everyday life.
Secondary Outcome Measures
Change in Cervical Range of Motion (ROM) measured by Universal Goniometer.
Change in Cervical Range of motion (ROM) from baseline was measured at 12th session.
Change in Craniovertebral angle CVA measured from a digitized, lateral-view photograph of each subject.
Change in Craniovertebral angle (CVA) from baseline was measured at 12th session. Craniovertebral angle (CVA) is a factor that significantly influences pain in those individuals with a forward head posture (FHP). Craniovertebral angle (CVA) (the angle between the horizontal line passing through C7 and a line extending from the tragus of the ear to C7).
Full Information
NCT ID
NCT04872335
First Posted
March 26, 2021
Last Updated
July 8, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04872335
Brief Title
Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy
Official Title
Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy for Chronic Neck Pain Among the Electronic Gadgets Users.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riphah International 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
This project was a Randomized clinical trial conducted to find out the Comparative Effects of Gong's Mobilization with Gradually Graded Exercise Therapy for Chronic Neck Pain among the users of Electronic Gadgets so that we can have best treatment option for patients.
Detailed Description
The study design was a Randomized Clinical Trial. For the study data was collected from sports and spine professionals. Sample size was calculated with the help of Epitool calculator. The study will be completed in 6 months duration. Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS) for pain intensity and Universal Goniometers for measuring (ROMs) and Forward head posture (FHP) were assessed before and 4 weeks after the treatment through the craniovertebral angle (CVA) measured from a digitized, lateral-view photograph of each subject. All the subjects were selected using Non Probability convenient sampling technique. The Subjects were randomly assigned to one of the following two groups: Gong's Mobilization (Group 1) or Gradually Graded Exercise Therapy (Group 2).This study was conducted in accordance with the rules of the Declaration of Helsinki. Written Informed consent were taken from all the subjects before participating in this trial. SPSS 25 was used for data entry and analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Neck Pain, Shoulder Syndrome
Keywords
Gong's Mobilization, Gradually graded exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gong's Mobilization
Arm Type
Experimental
Arm Description
Subjects received gong's mobilization three times in a week for 4 weeks.
Arm Title
Gradually Graded Exercise Therapy
Arm Type
Experimental
Arm Description
Subjects received gradually graded exercise therapy three times in a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Gong's Mobilization
Intervention Description
Group A received Gong's mobilization and common treatnent (TENs,Hot pack and cervical stretches). Gong's mobilization which is concurrent application of Apophyseal joint gliding and end range passive physiological movements while the subject's cervical postures are passively Neutral in order to induce Normal Cervical Extension. The Subjects in Group A were treated three times in a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Gradually Graded Exercise Therapy
Intervention Description
The Subjects in Group B were received Exercise Therapy and common treatment (TENs, Hot pack and cervical stretches) three times in a week continue for 4 weeks . Each exercise session will take 30 min. It will be consisted of 5 min warm-up exercises, 20 min stabilization exercises, 5 min cool-down, and stretching exercises including neck and shoulder girdle muscles.
The aim of Exercise program was to create a neutral spine and activate deep muscles of the cervical spine. The patients were educated to maintain neutral spine during the exercises and throughout the day as much as possible.
Scapulothoracic stabilization exercises were included_ specific exercises for the muscles affecting scapular orientation related to neck pain. The subjects were educated to maintain the positions and contractions during the exercises including scapular retraction, eccentric scapular retraction, and combined scapular retraction with shoulder lateral rotation, forward punch, and dynamic hug.
Primary Outcome Measure Information:
Title
Change in Pain Intensity by 'Numeric Pain Rating Scale'
Description
Change in pain from baseline was measured at 12th session. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by subject himself, under the supervision of researcher.
Time Frame
Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Title
Change in Neck disability Index 'NDI' score
Description
Change in Neck disability Index score 'NDI' from baseline was measured at 12th session. This questionnaire or tool has been designed to give us information as to how neck pain of the subject has affected his/her ability to manage in everyday life.
Time Frame
Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Secondary Outcome Measure Information:
Title
Change in Cervical Range of Motion (ROM) measured by Universal Goniometer.
Description
Change in Cervical Range of motion (ROM) from baseline was measured at 12th session.
Time Frame
Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Title
Change in Craniovertebral angle CVA measured from a digitized, lateral-view photograph of each subject.
Description
Change in Craniovertebral angle (CVA) from baseline was measured at 12th session. Craniovertebral angle (CVA) is a factor that significantly influences pain in those individuals with a forward head posture (FHP). Craniovertebral angle (CVA) (the angle between the horizontal line passing through C7 and a line extending from the tragus of the ear to C7).
Time Frame
Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:• Subjects with an age range of 15 to 65 years having Chronic neck pain for more than 3 months and subjects having a baseline NDI score of atleast 20% (10 points).
-
Exclusion Criteria:
• Cervical stenosis
History of traumatic Injury
Previous surgery related to cervical spine
Hypermobility
Cancer
Inflammatory rheumatologic diseases
Severe psychological disorders
Being pregnant and
Intervention including exercise or physical therapy in the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
Riphah IU
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26211422
Citation
Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
Results Reference
background
PubMed Identifier
26157273
Citation
Gong W. The effects of cervical joint manipulation, based on passive motion analysis, on cervical lordosis, forward head posture, and cervical ROM in university students with abnormal posture of the cervical spine. J Phys Ther Sci. 2015 May;27(5):1609-11. doi: 10.1589/jpts.27.1609. Epub 2015 May 26.
Results Reference
background
PubMed Identifier
23085116
Citation
McLean SM, Klaber Moffett JA, Sharp DM, Gardiner E. A randomised controlled trial comparing graded exercise treatment and usual physiotherapy for patients with non-specific neck pain (the GET UP neck pain trial). Man Ther. 2013 Jun;18(3):199-205. doi: 10.1016/j.math.2012.09.005. Epub 2012 Oct 22.
Results Reference
background
PubMed Identifier
30584494
Citation
Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.
Results Reference
background
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Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy
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