Neck SyndromeNCT05356676
Progressive Cervical Isometric Exercises Versus Scapular Stabilization Exercises in Text Neck Syndrome
A study testing Isometrics and Combination Therapy in people with Neck Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to investigate the effects of progressive cervical isometric exercises and scapular stabilization exercises on pain, ROM and disability in young adults with text neck syndrome. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Neck Syndrome
- What is being tested?
- Isometrics and Combination Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 15 Sep 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals using mobile phones for more than 6-8 hours.
- Participants both male and female of age between 18 to 28 years
- Participants with neck pain (>7 weeks)
- Participants with NDI score above 15/50 (10% or higher) or
- Participants with NPRS score above 3
Who cannot join
- Specific causes of neck pain (conditions with neurological involvement such as myelopathy with weakness, numbness and sensory loss, cervical disc prolapse, and cervical spinal stenosis)
- Previous neck and upper limb surgery.
- History of cervical trauma (whiplash disorder), fractures, dislocations.
- History of congenital torticollis, frequent migraine, carcinoma, acute pain and inflammation, torticollis, unstable/acute osteoarthritis, any recent fracture, vertigo, vertebrobasilar insufficiency, chronic heart disease, myocardial infarction or pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Services hospital
Lahore, Punjab Province, 38000
Nosheen Manzoor, 03236877879, Nosheenmanzoor_444@yahoo.com
Osama Ijaz, MS-OMPT
About this study
Official title: Effects of Progressive Cervical Isometric Exercises Versus Scapular Stabilization Exercises on Pain, Range of Motion and Disability in Young Adults With Text Neck Syndrome: A Randomised Controlled Trail
The aim of this study is to investigate the effects of progressive cervical isometric exercises and scapular stabilization exercises on pain, ROM and disability in young adults with text neck syndrome.
Read the detailed description
Text neck or Turtle neck posture is the latest term coined by Dr. Dean L. Fishman that demonstrates the repeated stress, injury, and pain in the neck due to having the head in a forward position by excessive use of cell phones or hand-held mobile devices for a prolonged time. The use of mobile devices is becoming a concern especially in children, recent numbers are very alarming and according to surveys 87% of teenagers in America and 79% of teenagers in the UK are mobile phone owners and are greatly affected by them, these numbers have skyrocketed by recent COVID-19 pandemic as the social distancing and closure of the school, colleges and offices have pushed us to work from home and it increases the prevalence of text neck syndrome. This study is unique in that as it investigate the effect of two different treatment plans for turtle neck syndrome.
- Conditions
- Neck Syndrome
- Being tested
- Isometrics, Combination Therapy
- Keywords
- progressive cervical neck isometrics, scapular stabilization exercises, pain, ROM, Text neck syndrome, turtle neck syndrome, disability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsometricsOther
Isometric neck extension -individuals will be taught to place their dominant hand posterior to their head at occiput. Then, they will be told to firmly push the head backwards against that hand, and hold for five seconds and repeat 5 times. • Participants will be asked to place the right hand flat on the same side of the head. Next.
they will be instructed to firmly push the head against right hand and hold for 5 seconds and repeat five times. Same exercise will be repeated with the left hand against the left side of the head as well.
- Participants will be taught to place their right hand on their right cheek. Then, they will be told to rum the face against the right hand and wait for 5 seconds and repeat five times. Same exercise was repeated with the left hand on the left cheek as well.
Combination TherapyOther
- In supine position, the patient will be instructed to take a deep breath in order to relax the body whilst holding his/her shoulders and neck in a comfortable posture.
- the patient will bend his/her knees and place their feet flat on the floor, and will hold the posture without any other neck movement. Then the patient will be asked to raise their dominant arm to 90° shoulder flexion along with full elbow extension and scapular protraction. This posture will be held for 10 seconds before returning to the prior position with 3 laps, 10 repetitions with a one-minute break between.
- in quadruped position, the patient will lift up their arms alternatively with shoulder abduction and 120 ° flexion. This posture will be held for 10 seconds before returning to the starting position for three laps, 10 repetitions with a 30-second break in between. Participants will be instructed to perform these for 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Isometrics | Experimental | They will be treated with progressive isometric exercises added to 60 min of combined therapy (excluding scapular stabilizing exercises) treatment session at alternative 3 days/week for 8weeks Receives: Other: Isometrics |
| Combination Therapy | Experimental | They will be treated with both isometric and scapular stabilizing exercises.and will get 60minutes of treatment sessions at alternative 3 days/week for 8weeks Receives: Other: Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NDI (Neck disability Index)
The Neck Disability Index (NDI) is modification of the Oswestry Low Back Pain Disability Index. It is Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation
Measured: 3 months
NPRS (Numeric Pain Rating Scale)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes
Measured: 3 months
Goniometer
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position
Measured: 3 months
Inclinometer
An inclinometer is a medical device used to measure the range of motion of the joint. They are mainly used to measure the passive range of motion and allow the medical practitioner to compare the patient's relaxed position to the ability to move
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Apr 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck SyndromeStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nosheen Manzoor, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356676
- Sponsor's protocol ID
- REC/Lhr/22/0112 Osama
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Cervical Isometric Exercises Versus Scapular Stabilization Exercises on Pain, Range of Motion and Disability in Young Adults With Text Neck Syndrome: A Randomised Controlled Trail
- ClinicalTrials.gov ID
- NCT05356676
- Acronym / sponsor ID
- REC/Lhr/22/0112 Osama
- Conditions
- Neck Syndrome
- Keywords
- progressive cervical neck isometrics, scapular stabilization exercises, pain, ROM, Text neck syndrome, turtle neck syndrome, disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 2 May 2022 (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.
The aim of this study is to investigate the effects of progressive cervical isometric exercises and scapular stabilization exercises on pain, ROM and disability in young adults with text neck syndrome.
Detailed description
Text neck or Turtle neck posture is the latest term coined by Dr. Dean L. Fishman that demonstrates the repeated stress, injury, and pain in the neck due to having the head in a forward position by excessive use of cell phones or hand-held mobile devices for a prolonged time. The use of mobile devices is becoming a concern especially in children, recent numbers are very alarming and according to surveys 87% of teenagers in America and 79% of teenagers in the UK are mobile phone owners and are greatly affected by them, these numbers have skyrocketed by recent COVID-19 pandemic as the social distancing and closure of the school, colleges and offices have pushed us to work from home and it increases the prevalence of text neck syndrome. This study is unique in that as it investigate the effect of two different treatment plans for turtle neck syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometrics | Experimental | Other: IsometricsThey will be treated with progressive isometric exercises added to 60 min of combined therapy (excluding scapular stabilizing exercises) treatment session at alternative 3 days/week for 8weeks |
| Combination Therapy | Experimental | Other: Combination TherapyThey will be treated with both isometric and scapular stabilizing exercises.and will get 60minutes of treatment sessions at alternative 3 days/week for 8weeks |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals using mobile phones for more than 6-8 hours.
Key exclusion criteria (4 listed)
- Specific causes of neck pain (conditions with neurological involvement such as myelopathy with weakness, numbness and sensory loss, cervical disc prolapse, and cervical spinal stenosis)
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 |
|---|---|---|
| IsometricsIsometric neck extension -individuals will be taught to place their dominant hand posterior to their head at occiput. Then, they will be told to firmly push the head backwards against that hand, and hold for five seconds and repeat 5 times. • Participants will be asked to place the right hand flat on the same side of the head. Next. they will be instructed to firmly push the head against right hand and hold for 5 seconds and repeat five times. Same exercise will be repeated with the left hand against the left side of the head as well. • Participants will be taught to place their right hand on their right cheek. Then, they will be told to rum the face against the right hand and wait for 5 seconds and repeat five times. Same exercise was repeated with the left hand on the left cheek as well. | Other | Isometrics |
| Combination Therapy1. In supine position, the patient will be instructed to take a deep breath in order to relax the body whilst holding his/her shoulders and neck in a comfortable posture. 2. the patient will bend his/her knees and place their feet flat on the floor, and will hold the posture without any other neck movement. Then the patient will be asked to raise their dominant arm to 90° shoulder flexion along with full elbow extension and scapular protraction. This posture will be held for 10 seconds before returning to the prior position with 3 laps, 10 repetitions with a one-minute break between. 3. in quadruped position, the patient will lift up their arms alternatively with shoulder abduction and 120 ° flexion. This posture will be held for 10 seconds before returning to the starting position for three laps, 10 repetitions with a 30-second break in between. Participants will be instructed to perform these for 3 times a week for 4 weeks. | Other | Combination Therapy |
Primary outcome
NDI (Neck disability Index)
Time frame: 3 months
The Neck Disability Index (NDI) is modification of the Oswestry Low Back Pain Disability Index. It is Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation
NPRS (Numeric Pain Rating Scale)
Time frame: 3 months
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes
Goniometer
Time frame: 3 months
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position
Inclinometer
Time frame: 3 months
An inclinometer is a medical device used to measure the range of motion of the joint. They are mainly used to measure the passive range of motion and allow the medical practitioner to compare the patient's relaxed position to the ability to move
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- 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.
Nosheen Manzoor, MS-OMPT 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 Isometrics and Combination Therapy in people with Neck Syndrome, 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: status not confirmed, as of the sponsor's last update on 2 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nosheen Manzoor, MS-OMPT (03236877879, nosheen.manzoor@riphahfsd.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NDI (Neck disability Index) (time frame: 3 months). The study lists 4 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 2 May 2022.