Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ELDOA method
Post-facilitation stretching
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Text Neck Syndrome
Eligibility Criteria
Inclusion Criteria:
• Neck pain without unilateral UE symptoms
- Age 18-35 years
- Subjects using Phone since past 1 year
- Neck disability index (NDI) score >10 points
- Participants able to understand and fill the questionnaire in English
Exclusion Criteria:
• Subjects having any congenital cervical condition
- Subjects having traumatic cervical condition such as whiplash injury within the past 6 weeks
- History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
- Subjects with cervical radiculopathy
Sites / Locations
- Safi Hospital Faisalabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ELDOA method
Post-facilitation stretching
Arm Description
Twenty (20) patients will be treated with ELDOA method
Twenty (20) patients will be treated with Post-facilitation stretching technique.
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale (NPRS)
will be used for pain measurement. It is a uni-dimensional 11 point scale (0-10) with measure of pain intensity.
Neck disability index (NDI)
) will be used to assess neck disability. It consists of 10 sections and each section carries 5 marks. 0 indicate no activity limitation and 5 indicates complete activity limitation.
Smartphone addiction scale (SAS)
will be used to assess smartphone addiction. It is self-reporting scale consist of 6 factors and 33 items. Score ranges from 33 to 198 and higher the score greater the degree of addiction.
Secondary Outcome Measures
Full Information
NCT ID
NCT05048992
First Posted
September 13, 2021
Last Updated
April 21, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05048992
Brief Title
Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
Official Title
Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
Yes
5. Study Description
Brief Summary
In this modern era, Text Neck is a new term used to describe neck pain and associated damage caused by continuous flexed posture due to excessive use of smartphones for a long time. The term text neck was first introduced by Dr. Dean L. Fishman, who is US based chiropractor. Text neck can also be described as overuse syndrome caused by repetitive stress on neck due to prolonged flexion. There is coordinated work between cervical spine and surrounding structure such as muscles, ligament, nerves and bones. In addition, any nerve compression at cervical spine leads to radiating pain in neck, shoulder and arm. Previous literature reported use of cell phone is very common in population of 18 to 44 years of age. Seventy nine percent (79%) population have smartphone with them all the time. Technology has become essential part of modern lifestyle. Sustained flexed posture forces the head to exert weight on neck of varying degrees. Weight of neutral head is 10 to 12 pounds and increases 6 times 1 inch forward movement of head. Children are at higher risk because of their large head size. This study will be a Randomized clinical trial with objective to reduce neck pain and disability in patients with text neck syndrome. Two groups will be designed, in one group ElDOA (n=20) and in other group post facilitation technique (n=20) will be applied. Patients will be recruited into two groups by consecutive sampling by non-replacement lottery method with equal no. of chits. Patients will be assessed by Numeric pain rating scale (NPRS), Neck disability index (NDI), smartphone addiction scale before and after treatment. Both groups will receive heating pad as common treatment first after that group A will be treated with ELDOA and group B will be treated with Post-facilitation. Session of 6 weeks with 3 days per week will be conducted. After that post treatment assessment will be done.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Text Neck Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELDOA method
Arm Type
Active Comparator
Arm Description
Twenty (20) patients will be treated with ELDOA method
Arm Title
Post-facilitation stretching
Arm Type
Active Comparator
Arm Description
Twenty (20) patients will be treated with Post-facilitation stretching technique.
Intervention Type
Other
Intervention Name(s)
ELDOA method
Intervention Description
group A will receive
Intervention Type
Other
Intervention Name(s)
Post-facilitation stretching
Intervention Description
Group B will receive
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
will be used for pain measurement. It is a uni-dimensional 11 point scale (0-10) with measure of pain intensity.
Time Frame
6 weeks
Title
Neck disability index (NDI)
Description
) will be used to assess neck disability. It consists of 10 sections and each section carries 5 marks. 0 indicate no activity limitation and 5 indicates complete activity limitation.
Time Frame
6 weeks
Title
Smartphone addiction scale (SAS)
Description
will be used to assess smartphone addiction. It is self-reporting scale consist of 6 factors and 33 items. Score ranges from 33 to 198 and higher the score greater the degree of addiction.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Neck pain without unilateral UE symptoms
Age 18-35 years
Subjects using Phone since past 1 year
Neck disability index (NDI) score >10 points
Participants able to understand and fill the questionnaire in English
Exclusion Criteria:
• Subjects having any congenital cervical condition
Subjects having traumatic cervical condition such as whiplash injury within the past 6 weeks
History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
Subjects with cervical radiculopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Safi Hospital Faisalabad
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Lee JI, Song HS. The correlation analysis between hours of smartphone use and neck pain in the Gachon university students. Journal of Acupuncture Research. 2014;31(2):99-109.
Results Reference
background
Citation
Neupane S, Ali U, Mathew A. Text neck syndrome-systematic review. Imperial Journal of Interdisciplinary Research. 2017;3(7):141-8
Results Reference
background
Citation
Vate-U-Lan P. Text neck epidemic: a growing problem for smart phone users in Thailand. International Journal of the Computer, the Internet and Management. 2015;23(3):551-6.
Results Reference
background
Learn more about this trial
Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
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