Neck PainNCT05048992
Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
A study testing ELDOA method and Post-facilitation stretching in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- ELDOA method and Post-facilitation stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neck Pain
- Being tested
- ELDOA method, Post-facilitation stretching
- Keywords
- Text Neck Syndrome
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELDOA methodOther
group A will receive
Post-facilitation stretchingOther
Group B will receive
| Study group | Role | What they receive |
|---|---|---|
| ELDOA method | Active comparator | Twenty (20) patients will be treated with ELDOA method Receives: Other: ELDOA method |
| Post-facilitation stretching | Active comparator | Twenty (20) patients will be treated with Post-facilitation stretching technique. Receives: Other: Post-facilitation stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start30 Oct 2021
- Primary completion15 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048992
- Sponsor's protocol ID
- RCE/Lhr/0116 Maryam
- Status last verified
- Apr 2022
- First submitted
- 13 Sep 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Neupane S, Ali U, Mathew A. Text neck syndrome-systematic review. Imperial Journal of Interdisciplinary Research. 2017;3(7):141-8
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
- ClinicalTrials.gov ID
- NCT05048992
- Acronym / sponsor ID
- RCE/Lhr/0116 Maryam
- Conditions
- Neck Pain
- Keywords
- Text Neck Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELDOA method | Active comparator | Other: ELDOA methodTwenty (20) patients will be treated with ELDOA method |
| Post-facilitation stretching | Active comparator | Other: Post-facilitation stretchingTwenty (20) patients will be treated with Post-facilitation stretching technique. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Neck pain without unilateral UE symptoms
Key exclusion criteria (4 listed)
- • Subjects having any congenital cervical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELDOA methodgroup A will receive | Other | ELDOA method |
| Post-facilitation stretchingGroup B will receive | Other | Post-facilitation stretching |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6 weeks
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)
Time frame: 6 weeks
) 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)
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- BackgroundLee 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.
- BackgroundNeupane S, Ali U, Mathew A. Text neck syndrome-systematic review. Imperial Journal of Interdisciplinary Research. 2017;3(7):141-8
- BackgroundVate-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Salman Bashir, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELDOA method and Post-facilitation stretching in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048992, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.