Upper Cross SyndromeNCT06104761
The Effect of Instrument- Assisted Soft Tissue Mobilization on Upper Crossed Syndrome
A study testing Release group and strength exercises and stretching for upper crossed syndrome in people with Upper Cross Syndrome, run by Cairo University.
Trial summary
This study will be a randomized controlled trial conducted to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in upper crossed syndrome patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Upper Cross Syndrome
- What is being tested?
- Release group and strength exercises and stretching for upper crossed syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Feb 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-Age ranged from 18 to 45 years . 2- All participants had intensity of neck pain on VAS (4-8) (moderate cases) . 3 - All participants had mechanical neck pain and FHP (craniovertebral angle CVA < 49) CVA of < 49) ..
- 4- All participants had kyphosis angle ≥45°.
Who cannot join
- 1- Malignancy. 2- Fractures of the cervical spine. 3- Cervical radiculopathy or myelopathy. 4- Vascular syndromes such as vertebrobasilar insufficiency. 5- Rheumatoid arthritis. 6- Neck or upper back surgery. 7- Taking anticoagulants. 8- Local infection.
Trial locations and contacts
No sites are listed yet.
About this study
This study will be a randomized controlled trial conducted to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in upper crossed syndrome patients. A sample size of 52 will be randomly allocated to two group ,(26 participants in each group), by using computer-generated random number list Control group will recieve conventional physical therapy in form of stretching and strengthening and experimental group will recieve firstly myofascial release with IASTM then applying the same conventional physical therapy of control group . Both groups will recieve 3 sessions per week for 4 weeks .
Read the detailed description
Upper crossed syndrome is characterized by the altered activation of specific muscles and postural deviations of the head, neck, and shoulders. Alterations in muscle activation include tightness of suboccipital and short erector spinae muscles of the neck, levator scapulae (LS), and upper trapezius (UT) muscles on the dorsal side crossed by tightness of pectoralis major (PM) and minor, sternocleidomastoid (SCM), and scalene muscles on the ventral side, and weakness of deep neck flexors (DNF) on the ventral side crossed by weakness of rhomboids, serratus anterior (SA), and middle and lower trapezius (LT) muscles on the dorsal side .
Because of UCS described as muscle imbalance pattern which located within the cervical and thoracic spine region. These imbalances have been shown to produce elevation and forward movement of the shoulders, winging of the scapula, and a forward extension of the head. These changes lead to overstress of the cervical cranial junction and shoulders, which can cause neck and/or jaw pain, headaches, and shoulder problems .
In this syndrome, the increased activity of accessory muscles of respiration disturbs the breathing, and the temporomandibular joint (TMJ) may develop osteoarthritis, resulting in chronic neck pain .
For the available literature, with the lack of evidence supporting about the effects of using myofascial release with IASTM on UCS patients. So the aim of this study was to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in UCS patients.
- Conditions
- Upper Cross Syndrome
- Being tested
- Release group, strength exercises and stretching for upper crossed syndrome
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release groupOther
i will make release for these muscles ( upper trapizius , levator scapulae , strenomastoid ) in addition to sub occipital fascia , then I will apply conventional physical therapy in form of stretching exercises (Trapezius (upper fibers) muscle , Levator scapulae muscle , Pectoralis major and Sternocleidomastoid muscles) and strengthening exercises for these muscles (Deep neck flexors, Trapezius (middle and lower fibers), Rhomboids and Serratus anterior muscles).
strength exercises and stretching for upper crossed syndromeOther
I will apply conventional physical therapy in form of stretching exercises (Trapezius (upper fibers) muscle , Levator scapulae muscle , Pectoralis major and Sternocleidomastoid muscles) and strengthening exercises for these muscles (Deep neck flexors, Trapezius (middle and lower fibers), Rhomboids and Serratus anterior muscles).
| Study group | Role | What they receive |
|---|---|---|
| Release Group | Experimental | Release of tight muscles in upper crossed syndrome Receives: Other: Release group; Other: strength exercises and stretching for upper crossed syndrome |
| Control group | Other | strength exercises and stretching for upper crossed syndrome Receives: Other: strength exercises and stretching for upper crossed syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical range of motion
The ROM of the cervical spine was measured using CROM device and CROM measurements had established validity which contains sagittal plane inclinometer, frontal plane inclinometer and transverse plane inclinometer Total active cervical flexion range in upright sitting , Total active cervical rotation ROM (right and left) in upright sitting , Total active cervical extension in upright sitting., Total active side pending ROM (right and left) in upright sitting .
Measured: up to 4 weeks
Chest Expansion
Tape measurement to measure chest expansion For the upper thoracic excursion, the tape measure placed at the level of the fifth thoracic spinous process and the third intercostal space at the midclavicular line For the lower thoracic excursion, the tape measure placed at the level of the 10th thoracic spinous process and the tip of the xiphoid process .
Measured: up to 4 weeks
Cranio verteberal angle
Digitized camera will be used it wiil be taken from lateral view photograph of the subject in his\her usual standing posture and taken again to minimize image distortion, and therapist placed a circular spirit level at the base of the camera to ensure that the camera is perpendicular to the horizontal level. Next, the tragus of the subject's ear will be marked and a plastic pointer will be attached to the skin overlying the C7 vertebra. Once the photograph is obtained, the therapist will use image to measure FHP, quantified by the cranio-vertbral angle (CVA) (the angle between the horizontal lines passing through C7and a line extending from the tragus of the ear to C7 notably). Lesser CVA indicates greater FHP
Measured: up to 4 weeks
Thoracic Kyphosis
Flexicurve ruler will be used to measure kyphosis The subject will be instructed to stand up straight and as tall as possible, and the flexicurve ruler will be aligned to the anterior-posterior curves of the spine from C7 to T12. The ruler will then placed flat on paper and its outline will be traced. A straight line was then drawn from the ruler position of C7 to T12 that corresponded to the length of thoracic kyphosis (l) and will be measured in cm. The height of the thoracic kyphosis (h) in cm will be determined by drawing a perpendicular line from the highest point in the thoracic curve to the point at which it will intersect the straight line drawn from C7 to T12. The index of kyphosis was calculated by applying the formula: (h/l ) x 100.
Measured: up to 4 weeks
pain Intenisty level
Numeric Pain Rating Scale (NPRS) will be used to measure pain intensity level To assess pain intensity it is the most widely used tool for estimating both severity of pain and to judge the extent of pain relief. Patient will asked to select a point on a line drawn between two ends to express how intense he/she perceives pain. It composed of 10 cm long, anchored by two verbal descriptors (i.e., "no pain" and "worst imaginable pain". Patients are asked to rate "current" pain intensity or pain intensity "in the last 24 hours"
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Cross SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Effect of instrument assisted sopf tissue mobilization on upper cross syndrome
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam omran Grase, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104761
- Sponsor's protocol ID
- IASTM
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instrument- Assisted Soft Tissue Mobilization on Upper Crossed Syndrome
- ClinicalTrials.gov ID
- NCT06104761
- Acronym / sponsor ID
- IASTM
- Conditions
- Upper Cross Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Oct 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.
This study will be a randomized controlled trial conducted to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in upper crossed syndrome patients. A sample size of 52 will be randomly allocated to two group ,(26 participants in each group), by using computer-generated random number list Control group will recieve conventional physical therapy in form of stretching and strengthening and experimental group will recieve firstly myofascial release with IASTM then applying the same conventional physical therapy of control group . Both groups will recieve 3 sessions per week for 4 weeks .
Detailed description
Upper crossed syndrome is characterized by the altered activation of specific muscles and postural deviations of the head, neck, and shoulders. Alterations in muscle activation include tightness of suboccipital and short erector spinae muscles of the neck, levator scapulae (LS), and upper trapezius (UT) muscles on the dorsal side crossed by tightness of pectoralis major (PM) and minor, sternocleidomastoid (SCM), and scalene muscles on the ventral side, and weakness of deep neck flexors (DNF) on the ventral side crossed by weakness of rhomboids, serratus anterior (SA), and middle and lower trapezius (LT) muscles on the dorsal side .
Because of UCS described as muscle imbalance pattern which located within the cervical and thoracic spine region. These imbalances have been shown to produce elevation and forward movement of the shoulders, winging of the scapula, and a forward extension of the head. These changes lead to overstress of the cervical cranial junction and shoulders, which can cause neck and/or jaw pain, headaches, and shoulder problems .
In this syndrome, the increased activity of accessory muscles of respiration disturbs the breathing, and the temporomandibular joint (TMJ) may develop osteoarthritis, resulting in chronic neck pain .
For the available literature, with the lack of evidence supporting about the effects of using myofascial release with IASTM on UCS patients. So the aim of this study was to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in UCS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Effect of instrument assisted sopf tissue mobilization on upper cross syndrome
| Arm | Type | Receives |
|---|---|---|
| Release Group | Experimental | Other: Release group, Other: strength exercises and stretching for upper crossed syndromeRelease of tight muscles in upper crossed syndrome |
| Control group | Other | Other: strength exercises and stretching for upper crossed syndromestrength exercises and stretching for upper crossed syndrome |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1-Age ranged from 18 to 45 years . 2- All participants had intensity of neck pain on VAS (4-8) (moderate cases) . 3 - All participants had mechanical neck pain and FHP (craniovertebral angle CVA < 49) CVA of < 49) ..
- 4- All participants had kyphosis angle ≥45°.
Key exclusion criteria (1 listed)
- 1- Malignancy. 2- Fractures of the cervical spine. 3- Cervical radiculopathy or myelopathy. 4- Vascular syndromes such as vertebrobasilar insufficiency. 5- Rheumatoid arthritis. 6- Neck or upper back surgery. 7- Taking anticoagulants. 8- Local infection.
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 |
|---|---|---|
| Release groupi will make release for these muscles ( upper trapizius , levator scapulae , strenomastoid ) in addition to sub occipital fascia , then I will apply conventional physical therapy in form of stretching exercises (Trapezius (upper fibers) muscle , Levator scapulae muscle , Pectoralis major and Sternocleidomastoid muscles) and strengthening exercises for these muscles (Deep neck flexors, Trapezius (middle and lower fibers), Rhomboids and Serratus anterior muscles). | Other | Release Group |
| strength exercises and stretching for upper crossed syndromeI will apply conventional physical therapy in form of stretching exercises (Trapezius (upper fibers) muscle , Levator scapulae muscle , Pectoralis major and Sternocleidomastoid muscles) and strengthening exercises for these muscles (Deep neck flexors, Trapezius (middle and lower fibers), Rhomboids and Serratus anterior muscles). | Other | Control group, Release Group |
Primary outcome
Cervical range of motion
Time frame: up to 4 weeks
The ROM of the cervical spine was measured using CROM device and CROM measurements had established validity which contains sagittal plane inclinometer, frontal plane inclinometer and transverse plane inclinometer Total active cervical flexion range in upright sitting , Total active cervical rotation ROM (right and left) in upright sitting , Total active cervical extension in upright sitting., Total active side pending ROM (right and left) in upright sitting .
Chest Expansion
Time frame: up to 4 weeks
Tape measurement to measure chest expansion For the upper thoracic excursion, the tape measure placed at the level of the fifth thoracic spinous process and the third intercostal space at the midclavicular line For the lower thoracic excursion, the tape measure placed at the level of the 10th thoracic spinous process and the tip of the xiphoid process .
Cranio verteberal angle
Time frame: up to 4 weeks
Digitized camera will be used it wiil be taken from lateral view photograph of the subject in his\her usual standing posture and taken again to minimize image distortion, and therapist placed a circular spirit level at the base of the camera to ensure that the camera is perpendicular to the horizontal level. Next, the tragus of the subject's ear will be marked and a plastic pointer will be attached to the skin overlying the C7 vertebra. Once the photograph is obtained, the therapist will use image to measure FHP, quantified by the cranio-vertbral angle (CVA) (the angle between the horizontal lines passing through C7and a line extending from the tragus of the ear to C7 notably). Lesser CVA indicates greater FHP
Thoracic Kyphosis
Time frame: up to 4 weeks
Flexicurve ruler will be used to measure kyphosis The subject will be instructed to stand up straight and as tall as possible, and the flexicurve ruler will be aligned to the anterior-posterior curves of the spine from C7 to T12. The ruler will then placed flat on paper and its outline will be traced. A straight line was then drawn from the ruler position of C7 to T12 that corresponded to the length of thoracic kyphosis (l) and will be measured in cm. The height of the thoracic kyphosis (h) in cm will be determined by drawing a perpendicular line from the highest point in the thoracic curve to the point at which it will intersect the straight line drawn from C7 to T12. The index of kyphosis was calculated by applying the formula: (h/l ) x 100.
pain Intenisty level
Time frame: up to 4 weeks
Numeric Pain Rating Scale (NPRS) will be used to measure pain intensity level To assess pain intensity it is the most widely used tool for estimating both severity of pain and to judge the extent of pain relief. Patient will asked to select a point on a line drawn between two ends to express how intense he/she perceives pain. It composed of 10 cm long, anchored by two verbal descriptors (i.e., "no pain" and "worst imaginable pain". Patients are asked to rate "current" pain intensity or pain intensity "in the last 24 hours"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Release group and strength exercises and stretching for upper crossed syndrome in people with Upper Cross Syndrome, run by Cairo University.
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 2 inclusion and 1 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud Hamad (00201006283618, mahmodhamada795@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical range of motion (time frame: up to 4 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 27 Oct 2023.