Neck PainNCT05730868
Effect of Exercise Among Turtle Neck Syndrome in Pakistani Patients
A study testing myofascial release, muscle energy technique and MFR & MET in people with Neck Pain, run by University of Karachi at 1 site in Pakistan.
Trial summary
Turtle neck also known as Text neck or anterior head syndrome is an overuse syndrome which occurs due to repetitive stress to neck, either by hanging it down or forward using phone or electronic devices. Typical signs and symptoms include pain and stiffness in the neck, shoulder pain and increase curvature of spine. 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?
- myofascial release, muscle energy technique and MFR & MET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 30 Jun 2023
- 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
- both males and females will be included
- patients having non specific neck pain
- usage of mobile more than six hours
- patients willing to participate
Who cannot join
- pregnant females
- patients having cervical disc bulge or herniation disoriented patients
- patients not willing to participate
- patients having any deformity
Trial locations and contacts
1 site in 1 country.
About this study
Turtle neck also known as Text neck or anterior head syndrome is an overuse syndrome which occurs due to repetitive stress to neck, either by hanging it down or forward using phone or electronic devices. Typical signs and symptoms include pain and stiffness in the neck, shoulder pain and increase curvature of spine. It is becoming a global burden as people of almost all ages are getting affected.
The objective of the study is to find out theEffect of Exercise among Turtle Neck Syndrome in Pakistani Population. A total of 100 participants will be included in the study having both males and females. The pain pattern will be assessed by Visual Analog Scale and Posture Grid Assessment tool will be used to assess posture before and after the treatment session.
The study will be divided into three main sections or groups. One group will be treated by myofascial release only while other group will be treated by muscle energy technique for the management of turtle neck syndrome. Third group will receive both MFP and MET exercise. People having neck pain and those who will be willing to participate will be included in the study.
Read the detailed description
The participants will be divided into four groups namely group A, B, C and D. Initially all the participants will be assessed by posture grid assessment tool to check their postural deviations. People meeting the inclusion criteria will be recruited. Group A will receive Muscle Energy Technique (MET) exercise, Group B will receive Myofascial release (MFP) therapy, Group C will receive both MFP and MET and group D will receive conventional treatment. Pre and post Visual analog scale (VAS) will be used to check pain scale and posture grid assessment tool to check postural angles .Pre-assessment will be done on day one and post at the last day of session. The total duration of treatment will be four weeks.
Consent will be taken from the patients. Only those patients meeting the inclusion criteria and screening questions will included in the study and those who will be willing to participate.
- Conditions
- Neck Pain
- Being tested
- myofascial release, muscle energy technique, MFR & MET, conventional therapy
- Keywords
- text neck syndrome, neck pain, Turtle neck syndrome, tissue hardness, pain pressure threshold
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial releaseProcedure or surgery
Soft tissue release will be performed on the trapezius, sub occipital and sternocleidomastoid muscles. The visual analog scale will be used to check pain intensity. Algometer will be used to check the pain pressure threshold and tissue hardness. neck disability index will be used to check neck disability
muscle energy techniqueProcedure or surgery
Muscle energy Technique will be performed on the trapezius, sub occipital and sternocleidomastoid muscles. The visual analog scale will be used to check pain intensity. Algometer will be used to check the pain pressure threshold and tissue hardness. neck disability index will be used to check neck disability
MFR & METProcedure or surgery
combination of myofascial release and muscle energy technique will be performed on the trapezius, suboccipital and sternocleidomastoid muscles. The visual analog scale will be used to check pain intensity. Algometer will be used to check the pain pressure threshold and tissue hardness. neck disability index will be used to check neck disability
conventional therapyProcedure or surgery
traditional physical therapy devices are used to relieve pain and spam. this will include a hot pack, ultrasound, and TENS (Transcutaneous electrical nerve stimulation)
| Study group | Role | What they receive |
|---|---|---|
| group 1 myofascial release | Experimental | soft tissue release technique to release tension from muscles which relieves pain and increase range of motion Receives: Procedure: myofascial release |
| group 2 muscle energy technique | Experimental | soft tissue release technique to release tension from muscles which relieves pain and increase range of motion Receives: Procedure: muscle energy technique |
| group 3 MFR & MET | Experimental | combination of two soft tissue release techniques to release tension from muscles which relieves pain and increase range of motion Receives: Procedure: MFR & MET |
| group 4 conventional therapy | Experimental | combination of traditional techniques to relieve pain and spasm Receives: Procedure: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
For pain intensity visual analog scale will be used. a patient oriented scale ranging from 0-10. 0 means no pain, 1-3 means mild pain, 4-6 means moderate pain and 7-10 means severe pain.
Measured: 2 years
Neck disability Index
to check disability, Neck disability Index will be used. It's a ten section questionnaire. Each item has scoring of 0-5. For each section the total possible score is 5.
Points are summed to a total score. 0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
Measured: 2 years
The tissue hardness assessed by Algometer measured in Newtons
For tissue hardness, Algometer will be used. It's a device that calculates the hardness when given pressure against the stimuli. The value is measured in Newtons.
Measured: 2 years
Pain pressure threshold assessed by Algometer measured in Newtons
For Pain pressure threshold, Algometer will be used. It's a device that calculates the pain pressure threshold when given pressure against the stimuli. The value is measured in Newtons.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck 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 control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Tul Kubra, PT, University of Karachi
- Investigators
- Khadija Tul Kubra, M.phil, Principal investigator, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730868
- Sponsor's protocol ID
- KTKYasin
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no their is no plan to share IPD
Publications
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
PubMed 25603749Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.
PubMed 30931028
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Among Turtle Neck Syndrome in Pakistani Patients
- ClinicalTrials.gov ID
- NCT05730868
- Acronym / sponsor ID
- KTKYasin
- Conditions
- Neck Pain
- Keywords
- text neck syndrome, neck pain, Turtle neck syndrome, tissue hardness, pain pressure threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Feb 2023 (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.
Turtle neck also known as Text neck or anterior head syndrome is an overuse syndrome which occurs due to repetitive stress to neck, either by hanging it down or forward using phone or electronic devices. Typical signs and symptoms include pain and stiffness in the neck, shoulder pain and increase curvature of spine. It is becoming a global burden as people of almost all ages are getting affected.
The objective of the study is to find out theEffect of Exercise among Turtle Neck Syndrome in Pakistani Population. A total of 100 participants will be included in the study having both males and females. The pain pattern will be assessed by Visual Analog Scale and Posture Grid Assessment tool will be used to assess posture before and after the treatment session.
The study will be divided into three main sections or groups. One group will be treated by myofascial release only while other group will be treated by muscle energy technique for the management of turtle neck syndrome. Third group will receive both MFP and MET exercise. People having neck pain and those who will be willing to participate will be included in the study.
Detailed description
The participants will be divided into four groups namely group A, B, C and D. Initially all the participants will be assessed by posture grid assessment tool to check their postural deviations. People meeting the inclusion criteria will be recruited. Group A will receive Muscle Energy Technique (MET) exercise, Group B will receive Myofascial release (MFP) therapy, Group C will receive both MFP and MET and group D will receive conventional treatment. Pre and post Visual analog scale (VAS) will be used to check pain scale and posture grid assessment tool to check postural angles .Pre-assessment will be done on day one and post at the last day of session. The total duration of treatment will be four weeks.
Consent will be taken from the patients. Only those patients meeting the inclusion criteria and screening questions will included in the study and those who will be willing to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| group 1 myofascial release | Experimental | Procedure: myofascial releasesoft tissue release technique to release tension from muscles which relieves pain and increase range of motion |
| group 2 muscle energy technique | Experimental | Procedure: muscle energy techniquesoft tissue release technique to release tension from muscles which relieves pain and increase range of motion |
| group 3 MFR & MET | Experimental | Procedure: MFR & METcombination of two soft tissue release techniques to release tension from muscles which relieves pain and increase range of motion |
| group 4 conventional therapy | Experimental | Procedure: conventional therapycombination of traditional techniques to relieve pain and spasm |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- both males and females will be included
- patients having non specific neck pain
- usage of mobile more than six hours
- patients willing to participate
Key exclusion criteria (4 listed)
- pregnant females
- patients having cervical disc bulge or herniation disoriented patients
- patients not willing to participate
- patients having any deformity
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 |
|---|---|---|
| myofascial releaseSoft tissue release will be performed on the trapezius, sub occipital and sternocleidomastoid muscles. The visual analog scale will be used to check pain intensity. Algometer will be used to check the pain pressure threshold and tissue hardness. neck disability index will be used to check neck disability | Procedure or surgery | group 1 myofascial release |
| muscle energy techniqueMuscle energy Technique will be performed on the trapezius, sub occipital and sternocleidomastoid muscles. The visual analog scale will be used to check pain intensity. Algometer will be used to check the pain pressure threshold and tissue hardness. neck disability index will be used to check neck disability | Procedure or surgery | group 2 muscle energy technique |
| MFR & METcombination of myofascial release and muscle energy technique will be performed on the trapezius, suboccipital and sternocleidomastoid muscles. The visual analog scale will be used to check pain intensity. Algometer will be used to check the pain pressure threshold and tissue hardness. neck disability index will be used to check neck disability | Procedure or surgery | group 3 MFR & MET |
| conventional therapytraditional physical therapy devices are used to relieve pain and spam. this will include a hot pack, ultrasound, and TENS (Transcutaneous electrical nerve stimulation) | Procedure or surgery | group 4 conventional therapy |
Primary outcome
visual analog scale
Time frame: 2 years
For pain intensity visual analog scale will be used. a patient oriented scale ranging from 0-10. 0 means no pain, 1-3 means mild pain, 4-6 means moderate pain and 7-10 means severe pain.
Neck disability Index
Time frame: 2 years
to check disability, Neck disability Index will be used. It's a ten section questionnaire. Each item has scoring of 0-5. For each section the total possible score is 5. Points are summed to a total score. 0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
The tissue hardness assessed by Algometer measured in Newtons
Time frame: 2 years
For tissue hardness, Algometer will be used. It's a device that calculates the hardness when given pressure against the stimuli. The value is measured in Newtons.
Pain pressure threshold assessed by Algometer measured in Newtons
Time frame: 2 years
For Pain pressure threshold, Algometer will be used. It's a device that calculates the pain pressure threshold when given pressure against the stimuli. The value is measured in Newtons.
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 30 Nov 2023.
- Background: PubMed 25603749Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
- Background: PubMed 30931028Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. no their is no plan to share IPD
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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.
Khadija Tul Kubra, M.phil principal investigator
University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial release, muscle energy technique and MFR & MET in people with Neck Pain, run by University of Karachi 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 4 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 30 Nov 2023. 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?
visual analog scale (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT05730868, which also lists 2 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 30 Nov 2023.