PainNCT03374059
Exercise and Life Modification for Text-Neck
A study testing Exercise program and Life modification in people with Pain and Exercise, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck". Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Exercise program and Life modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2016to 1 Sep 2017
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who were aged between 18 and 30, using technological devices as tablets and smartphones for more than 5 hours and having neck pain for more than 3 months were included in our study.
Who cannot join
- The exclusion criteria included those:
- who had any diagnosed pathology for neck region diagnosed by MR or BT,
- who had any shoulder pathology,
- with any neck or shoulder surgery,
- had whiplash syndrome,
- had fibromyalgia, Myofasial Pain Syndrome or vascular pathology and
- women who are breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise and Life Modification Approaches for Text-Neck
Objectives: The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".
Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.
Read the detailed description
Objectives: Smartphones or tablets have made an important place in our lives. However long-term use of technological tools causes postural disorders and neck pain called "text neck". The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".
Methods: Eighty-five participants with "text-neck" were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). First group received a home exercise program treatment for 4 weeks. Second group received life modification suggestions additional to home exercise treatment program. Control group did not receive any treatments. Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.
- Being tested
- Exercise program, Life modification
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Life modificationOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise group received a home exercise program treatment for 4 weeks including isometric exercises for neck muscles and postural correction exercises for neck region. Receives: Other: Exercise program |
| Exercise and Life modification | Experimental | This group received life modification suggestions additional to home exercise treatment program for 4 weeks. Receives: Other: Exercise program; Other: Life modification |
| Control Group | No intervention | Control group did not receive any treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity
Measured: 4 weeks
Secondary outcomes (1)
Neck disability index
Function
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374059
- Sponsor's protocol ID
- KA 16/376
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Life Modification Approaches for Text-Neck
- ClinicalTrials.gov ID
- NCT03374059
- Acronym / sponsor ID
- KA 16/376
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 15 Dec 2017 (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.
Objectives: The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".
Methods: Eighty-five participants were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.
Detailed description
Objectives: Smartphones or tablets have made an important place in our lives. However long-term use of technological tools causes postural disorders and neck pain called "text neck". The purpose of the study was to investigate the effects of exercise and life modification on pain and disability in "text neck".
Methods: Eighty-five participants with "text-neck" were randomly divided into three groups: Exercise (n=29), Exercise+Life modification (n=28), and Control Group (n = 28). First group received a home exercise program treatment for 4 weeks. Second group received life modification suggestions additional to home exercise treatment program. Control group did not receive any treatments. Pain intensity during rest, activity, and at night was evaluated with Visual Analogue Scale (VAS) and functional assessment was done by using Neck Disability Index at the beginning and at the end of 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise programExercise group received a home exercise program treatment for 4 weeks including isometric exercises for neck muscles and postural correction exercises for neck region. |
| Exercise and Life modification | Experimental | Other: Exercise program, Other: Life modificationThis group received life modification suggestions additional to home exercise treatment program for 4 weeks. |
| Control Group | No intervention | –Control group did not receive any treatments |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants who were aged between 18 and 30, using technological devices as tablets and smartphones for more than 5 hours and having neck pain for more than 3 months were included in our study.
Key exclusion criteria (7 listed)
- The exclusion criteria included those:
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 |
|---|---|---|
| Exercise program | Other | Exercise, Exercise and Life modification |
| Life modification | Other | Exercise and Life modification |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
Pain intensity
1 secondary outcome
Neck disability index
Time frame: 4 weeks
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 15 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program and Life modification in people with Pain and Exercise, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 15 Dec 2017. 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 Turkey (Türkiye). 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?
Visual Analogue Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2017.