Neck Muscle IssueNCT06306807
Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Text Neck Syndrome
A study testing Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications and PNF exercise program in people with Neck Muscle Issue, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Muscle Issue
- What is being tested?
- Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications and PNF exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2023to 15 Mar 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 1 year of using a smartphone
- using smartphones>4 hours per day, having recurrent neck pain which is increased by sustained posture and feeling of stiffness on turning the head and neck after long usages
- be able to read written and understand spoken language and willing to participate were included.
Who cannot join
- Subjects with spinal infections or inflammatory disorders
- a history of neck surgery, trauma, torticollis, scoliosis, malignancies, pregnancy, diagnosed disc prolapse, stenosis, herniation, spondylolisthesis, osteoporosis
- currently continuing or participating in a regular exercise program
- unable to perform tests or exercises because of diagnosed comorbidities or presently undergoing medication or physical therapy treatments
Trial locations and contacts
1 site in 1 country.
About this study
Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment.
Read the detailed description
Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment. Our study is planned as a randomized controlled, prospective, single-blind case-control study. Demographic and clinical information of all participants to be included in the study will be recorded with the "Demographic and Clinical Information Form". Neck pain will be assessed by visual analog scale (VAS), cervical joint normal range of motion will be assessed by cervical flexion, cervical extension, cervical lateral flexion and cervical rotation normal range of motion measurements, neck muscle endurance will be assessed by neck flexor and extensor muscle endurance tests, posture will be assessed by New York Posture Evaluation Scale and functionality will be assessed by Neck Disability Index.
- Conditions
- Neck Muscle Issue
- Being tested
- Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications, PNF exercise program
- Keywords
- Text Neck Syndrome, Neck Pain, Range of Motion, Posture, Disability
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modificationsOther
Active cervical range of motion exercise program consists of the general range of movement for flexors, extensors, both sides flexors, and rotator neck muscles. Participants were instructed to perform exercises in a sitting position, but they were allowed to perform exercises in supine and prone lying if they had problems with sitting position. Strengthening exercises were planned for weak, lengthened, inhibited muscles e.g. Longus colli, and longus capitis. Chin tucks, chin tucks against gravity, and chin nod exercises were selected. Ergonomic modifications while using a smartphone were taught such as taking breaks and changing positions frequently while using a smartphone, avoiding cradling the phone between your ear and shoulder, choosing a smartphone that fits your hands properly, holding the smartphone near chest level rather than waist level, and using features including predictive text or auto-complete tools
PNF exercise programOther
The contract-relax technique for the neck extension pattern and the replication technique for the scapular posterior elevation pattern were used.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group underwent the exercise program including active cervical range of motion, strengthening, and posture correction exercises for 6 weeks, 3 days a week, once a day for 10 repetitions. Active cervical range of motion exercise program consists of the general range of movement for flexors, extensors, both sides flexors, and rotator neck muscles. Strengthening exercises were planned for weak, lengthened, inhibited muscles. Ergonomic modifications while using a smartphone were taught. Additionally, participants in the experimental group were included in a PNF exercise program to be applied by a physiotherapist 3 days a week for 6 weeks. The contract-relax technique for the neck extension pattern and the replication technique for the scapular posterior elevation pattern were used. Receives: Other: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications; Other: PNF exercise program |
| Control Group | Active comparator | Participants in the experimental group underwent the exercise program including active cervical range of motion, strengthening, and posture correction exercises for 6 weeks, 3 days a week, once a day for 10 repetitions. Active cervical range of motion exercise program consists of the general range of movement for flexors, extensors, both sides flexors, and rotator neck muscles. Strengthening exercises were planned for weak, lengthened, inhibited muscles. Ergonomic modifications while using a smartphone were taught. Receives: Other: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The neck pain score was measured using the visual analog scale. The VAS is a subjective scoring method for recording the degree of present pain from 0 (no pain) to 10 (the most severe pain ever experienced) on a 10-cm scale. The minimum clinical important difference (MCID) for VAS is 1.4 cm (on a 10 cm scale)
Measured: 6 weeks
Cervical range of motion
Active cervical range of motion was measured in all directions with a plastic universal goniometer. Participants were instructed to sit upright while securing their thoracic area to a chair to assess their cervical range of motion. They were then directed to perform a series of standard movements: flexion, extension, left-right lateral flexion, and left-right rotation. Three consecutive measurements were obtained and the average value was recorded as degree. Before measurements, all participants were encouraged to perform each neck movement to the end range to familiarize themselves with the testing method and to reduce the creep.
Measured: 6 weeks
Neck flexor-extensor muscle endurance test
The neck flexor muscle endurance test was performed in the supine and crook lying position. The participant lifted the head and neck until the head was approximately 2.5 cm off the plinth. The "hold your head up" command was given. The test was stopped if the participant's head touched the investigator's hand for over one second. Holding time was recorded in seconds with a stopwatch. The neck extensor muscle endurance test was performed in the prone position. The participant was asked to retract the chin and hold the head steady horizontally. The test was stopped if the subject could not maintain the head in a horizontal position. The endurance time was measured in seconds by stopwatch
Measured: 6 weeks
Posture
The evaluation of posture involved using the New York Posture Rating Chart (NYPR), a cost-effective, easily applicable method commonly employed for subjective postural assessment in clinical settings. This chart allows for the assessment of 13 body areas, based on the idea that posture reflects the body's alignment and its various segments.
Measured: 6 weeks
Disability
The assessment of disability relied on the Neck Disability Index (NDI), comprising a self-reported scale of 10 items. Each item addresses various complaints related to neck pain, primarily focusing on limitations in activities of daily living. Each item is represented by six different statements, graded on a scale from 0 to 5, where 0 denotes no disability and 5 signifies the most severe disability.
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 posted12 Mar 2024
- Study start31 Dec 2023
- Primary completion14 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Muscle IssueStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Kaya, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306807
- Sponsor's protocol ID
- AtlasUmkaya02
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Text Neck Syndrome
- ClinicalTrials.gov ID
- NCT06306807
- Acronym / sponsor ID
- AtlasUmkaya02
- Conditions
- Neck Muscle Issue
- Keywords
- Text Neck Syndrome, Neck Pain, Range of Motion, Posture, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 12 Mar 2024 (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.
Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment.
Detailed description
Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment. Our study is planned as a randomized controlled, prospective, single-blind case-control study. Demographic and clinical information of all participants to be included in the study will be recorded with the "Demographic and Clinical Information Form". Neck pain will be assessed by visual analog scale (VAS), cervical joint normal range of motion will be assessed by cervical flexion, cervical extension, cervical lateral flexion and cervical rotation normal range of motion measurements, neck muscle endurance will be assessed by neck flexor and extensor muscle endurance tests, posture will be assessed by New York Posture Evaluation Scale and functionality will be assessed by Neck Disability Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications, Other: PNF exercise programParticipants in the experimental group underwent the exercise program including active cervical range of motion, strengthening, and posture correction exercises for 6 weeks, 3 days a week, once a day for 10 repetitions. Active cervical range of motion exercise program consists of the general range of movement for flexors, extensors, both sides flexors, and rotator neck muscles. Strengthening exercises were planned for weak, lengthened, inhibited muscles. Ergonomic modifications while using a smartphone were taught. Additionally, participants in the experimental group were included in a PNF exercise program to be applied by a physiotherapist 3 days a week for 6 weeks. The contract-relax technique for the neck extension pattern and the replication technique for the scapular posterior elevation pattern were used. |
| Control Group | Active comparator | Other: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modificationsParticipants in the experimental group underwent the exercise program including active cervical range of motion, strengthening, and posture correction exercises for 6 weeks, 3 days a week, once a day for 10 repetitions. Active cervical range of motion exercise program consists of the general range of movement for flexors, extensors, both sides flexors, and rotator neck muscles. Strengthening exercises were planned for weak, lengthened, inhibited muscles. Ergonomic modifications while using a smartphone were taught. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 1 year of using a smartphone
- using smartphones>4 hours per day, having recurrent neck pain which is increased by sustained posture and feeling of stiffness on turning the head and neck after long usages
- be able to read written and understand spoken language and willing to participate were included.
Key exclusion criteria (4 listed)
- Subjects with spinal infections or inflammatory disorders
- a history of neck surgery, trauma, torticollis, scoliosis, malignancies, pregnancy, diagnosed disc prolapse, stenosis, herniation, spondylolisthesis, osteoporosis
- currently continuing or participating in a regular exercise program
- unable to perform tests or exercises because of diagnosed comorbidities or presently undergoing medication or physical therapy treatments
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 including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modificationsActive cervical range of motion exercise program consists of the general range of movement for flexors, extensors, both sides flexors, and rotator neck muscles. Participants were instructed to perform exercises in a sitting position, but they were allowed to perform exercises in supine and prone lying if they had problems with sitting position. Strengthening exercises were planned for weak, lengthened, inhibited muscles e.g. Longus colli, and longus capitis. Chin tucks, chin tucks against gravity, and chin nod exercises were selected. Ergonomic modifications while using a smartphone were taught such as taking breaks and changing positions frequently while using a smartphone, avoiding cradling the phone between your ear and shoulder, choosing a smartphone that fits your hands properly, holding the smartphone near chest level rather than waist level, and using features including predictive text or auto-complete tools | Other | Control Group, Experimental Group |
| PNF exercise programThe contract-relax technique for the neck extension pattern and the replication technique for the scapular posterior elevation pattern were used. | Other | Experimental Group |
Primary outcome
Pain intensity
Time frame: 6 weeks
The neck pain score was measured using the visual analog scale. The VAS is a subjective scoring method for recording the degree of present pain from 0 (no pain) to 10 (the most severe pain ever experienced) on a 10-cm scale. The minimum clinical important difference (MCID) for VAS is 1.4 cm (on a 10 cm scale)
Cervical range of motion
Time frame: 6 weeks
Active cervical range of motion was measured in all directions with a plastic universal goniometer. Participants were instructed to sit upright while securing their thoracic area to a chair to assess their cervical range of motion. They were then directed to perform a series of standard movements: flexion, extension, left-right lateral flexion, and left-right rotation. Three consecutive measurements were obtained and the average value was recorded as degree. Before measurements, all participants were encouraged to perform each neck movement to the end range to familiarize themselves with the testing method and to reduce the creep.
Neck flexor-extensor muscle endurance test
Time frame: 6 weeks
The neck flexor muscle endurance test was performed in the supine and crook lying position. The participant lifted the head and neck until the head was approximately 2.5 cm off the plinth. The "hold your head up" command was given. The test was stopped if the participant's head touched the investigator's hand for over one second. Holding time was recorded in seconds with a stopwatch. The neck extensor muscle endurance test was performed in the prone position. The participant was asked to retract the chin and hold the head steady horizontally. The test was stopped if the subject could not maintain the head in a horizontal position. The endurance time was measured in seconds by stopwatch
Posture
Time frame: 6 weeks
The evaluation of posture involved using the New York Posture Rating Chart (NYPR), a cost-effective, easily applicable method commonly employed for subjective postural assessment in clinical settings. This chart allows for the assessment of 13 body areas, based on the idea that posture reflects the body's alignment and its various segments.
Disability
Time frame: 6 weeks
The assessment of disability relied on the Neck Disability Index (NDI), comprising a self-reported scale of 10 items. Each item addresses various complaints related to neck pain, primarily focusing on limitations in activities of daily living. Each item is represented by six different statements, graded on a scale from 0 to 5, where 0 denotes no disability and 5 signifies the most severe disability.
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 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Neck Muscle Issue
Recruiting
Analyzing Positional Release Therapy and Dry Needling
Neck Muscle Issue
RecruitingPhase 4
BoTox Into the Sternocleidomastoid Muscles (SCM)
Neck Muscle Issue
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 including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications and PNF exercise program in people with Neck Muscle Issue, run by Atlas 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 3 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 15 Mar 2024. 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?
Pain intensity (time frame: 6 weeks). The study lists 5 primary outcomes in all. 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 Mar 2024.