Upper Crossed SyndromeNCT05665296
Effect of Cervicothoracic Mobilization on Upper Crossed Syndrome
A study testing cervicothoracic mobilization and CCE in people with Upper Crossed Syndrome, run by Cairo University.
Trial summary
PURPOSE: To investigate the effect of cervicothoracic mobilization on Craniovertebral angle (CVA), sagittal shoulder angle (SSA), kyphotic angle and pain intensity level in upper crossed syndrome. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Upper Crossed Syndrome
- What is being tested?
- cervicothoracic mobilization and CCE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Sep 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-50 years .
- Participants will included if their CVA less than 48° ( SSA less than 52°) , as above these values are considered normal and thoracic kyphosis (with flexicurve angle more than 45 degrees) .
- Subjects who have weakness in deep neck flexors, serratus anterior, middle and lower trapezius and rhomboid muscles and tightness in upper trapezius, levator scapulae, scalene, posterior neck and suboccipital muscles, pectoralis major and minor and sternocleidomastoid muscles.
- Subject complaining of this symptom for more than 3mothes.
- Marking pain intensity score visual analog scale (VAS) ≥3 in neck and shoulder
Who cannot join
- History of surgery or joint diseases of the spine or shoulder.
- Osteoporosis, or fracture ,cervical instability or any sign those with other contraindications against joint mobilization.
- Individuals with any cervical condition e.g. radiculopathy, cervical rib, whiplash injury and individuals with any neurological/ condition .
- History of congenital spinal deformity (congenital scoliosis) .
- Any malignancy related to soft tissue and joints .
- Subjects taking analgesics and/or muscle relaxants.
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- pregnancy.
- Being in weight out of the normal range (18 ≥ BMI ≥ 25).
- Cognitive impairment and inability to understand the scale.
Trial locations and contacts
No sites are listed yet.
About this study
PURPOSE: To investigate the effect of cervicothoracic mobilization on Craniovertebral angle (CVA), sagittal shoulder angle (SSA), kyphotic angle and pain intensity level in upper crossed syndrome.
Read the detailed description
Upper crossed syndrome and its associated neck pain is considered to be the fourth most frequent cause of disability with an annual 30% increase in the rate of prevalence. According to the report on Global burden of diseases (GBD) 2010, neck pain is ranked 21st in terms overall burden of diseases. Musculoskeletal pain in the neck and upper limbs is common; population studies suggest that 6-48% of adults have pain in one of these areas .
Recently, joint mobilization has proven to be effective, and it is now frequently used in clinics .Cervical mobilization combined with thoracic mobilization is recommended as a clinical intervention for neck pain patients with forward head posture ( FHP) rather than cervical mobilization alone. This study has two groups; one will receive cervicothoracic Mobilization + conventional treatment and the second will receive conventional treatment for eight weeks.
- Conditions
- Upper Crossed Syndrome
- Being tested
- cervicothoracic mobilization, CCE
- Keywords
- Forward head posture, Rounded Shoulders, Thoracic kyphosis, UCS, Mobilization
- 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.
cervicothoracic mobilizationOther
Each participant in study group will receive cervicothoracic mobilization (central PA and transverse Grade III or grade IV) with comprehensive corrective exercise. The duration will eight weeks three sessions per week.
CCEOther
Each participant will receive comprehensive corrective exercise include three phases: Initial phase -Improvement phase and Maintenance phase.
The initial phase exercises progress in frequency and intensity during this phase, as long as participants are able to demonstrate good quality movement. The initial phase duration is 2 weeks and the exercises will be performed for seven sets of 10-s hold .
Improvement phase exercises are progressed by considering individual characteristics of each participant and by observing the overload principle and the progression in the number of repetitions of each set during the 4 weeks of the improvement phase. The exercises will be performed from five sets of ten repetitions to six sets of 15 repetitions .
Maintenance phase exercises:The exercises are the same as in the improvement phase without any progression in intensity and frequency. The maintenance phase duration is 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| cervicothoracic mobilization | Experimental | This group will receive cervicothoracic mobilization with comprehensive corrective exercise Receives: Other: cervicothoracic mobilization; Other: CCE |
| control group: comprehensive corrective exercise (CCE). | Active comparator | This group will receive traditional treatment comprehensive corrective exercise (CCE). Receives: Other: CCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Craniovertebral angle (CVA) .
Craniovertebral angle (CVA) will be measured using Computerized photogrammetry is utilized markers, Digital camera and Kinovea software.
Measured: before treatment,and after eight weeks of treatment.
change in Sagittal shoulder angle (SSA).
Sagittal shoulder angle (SSA) will be measured using Computerized photogrammetry is utilized markers, Digital camera and Kinovea software.
Measured: before treatment,and after eight weeks of treatment.
change in thoracic kyphosis angle.
thoracic kyphosis angle will be measured using the flexicurve ruler
Measured: before treatment,and after eight weeks of treatment.
change in pain level
pain severity will be measured using visual analogue scale Each participant will be asked to put a mark on a 10-cm horizontal line that is marked with 'zero' at one end to indicate no pain and marked with'10' at the other end to indicate maximum pain.
Measured: before treatment,and after eight weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study startApr 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Crossed 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohamed Atta El-Kaffas, Cairo University
- Investigators
- Abeer Yamany, professor, Study chair, Professor of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665296
- Sponsor's protocol ID
- P.T.REC/012/003840
- Status last verified
- Apr 2023
- First submitted
- 16 Dec 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seidi F, Bayattork M, Minoonejad H, Andersen LL, Page P. Comprehensive corrective exercise program improves alignment, muscle activation and movement pattern of men with upper crossed syndrome: randomized controlled trial. Sci Rep. 2020 Nov 26;10(1):20688. doi: 10.1038/s41598-020-77571-4.
PubMed 33244045
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervicothoracic Mobilization on Upper Crossed Syndrome
- ClinicalTrials.gov ID
- NCT05665296
- Acronym / sponsor ID
- P.T.REC/012/003840
- Conditions
- Upper Crossed Syndrome
- Keywords
- Forward head posture, Rounded Shoulders, Thoracic kyphosis, UCS, Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Dec 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.
PURPOSE: To investigate the effect of cervicothoracic mobilization on Craniovertebral angle (CVA), sagittal shoulder angle (SSA), kyphotic angle and pain intensity level in upper crossed syndrome.
Detailed description
Upper crossed syndrome and its associated neck pain is considered to be the fourth most frequent cause of disability with an annual 30% increase in the rate of prevalence. According to the report on Global burden of diseases (GBD) 2010, neck pain is ranked 21st in terms overall burden of diseases. Musculoskeletal pain in the neck and upper limbs is common; population studies suggest that 6-48% of adults have pain in one of these areas .
Recently, joint mobilization has proven to be effective, and it is now frequently used in clinics .Cervical mobilization combined with thoracic mobilization is recommended as a clinical intervention for neck pain patients with forward head posture ( FHP) rather than cervical mobilization alone. This study has two groups; one will receive cervicothoracic Mobilization + conventional treatment and the second will receive conventional treatment for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervicothoracic mobilization | Experimental | Other: cervicothoracic mobilization, Other: CCEThis group will receive cervicothoracic mobilization with comprehensive corrective exercise |
| control group: comprehensive corrective exercise (CCE). | Active comparator | Other: CCEThis group will receive traditional treatment comprehensive corrective exercise (CCE). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20-50 years .
- Participants will included if their CVA less than 48° ( SSA less than 52°) , as above these values are considered normal and thoracic kyphosis (with flexicurve angle more than 45 degrees) .
- Subjects who have weakness in deep neck flexors, serratus anterior, middle and lower trapezius and rhomboid muscles and tightness in upper trapezius, levator scapulae, scalene, posterior neck and suboccipital muscles, pectoralis major and minor and sternocleidomastoid muscles.
- Subject complaining of this symptom for more than 3mothes.
- Marking pain intensity score visual analog scale (VAS) ≥3 in neck and shoulder
Key exclusion criteria (9 listed)
- History of surgery or joint diseases of the spine or shoulder.
- Osteoporosis, or fracture ,cervical instability or any sign those with other contraindications against joint mobilization.
- Individuals with any cervical condition e.g. radiculopathy, cervical rib, whiplash injury and individuals with any neurological/ condition .
- History of congenital spinal deformity (congenital scoliosis) .
- Any malignancy related to soft tissue and joints .
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 |
|---|---|---|
| cervicothoracic mobilizationEach participant in study group will receive cervicothoracic mobilization (central PA and transverse Grade III or grade IV) with comprehensive corrective exercise. The duration will eight weeks three sessions per week. | Other | cervicothoracic mobilization |
| CCEEach participant will receive comprehensive corrective exercise include three phases: Initial phase -Improvement phase and Maintenance phase. The initial phase exercises progress in frequency and intensity during this phase, as long as participants are able to demonstrate good quality movement. The initial phase duration is 2 weeks and the exercises will be performed for seven sets of 10-s hold . Improvement phase exercises are progressed by considering individual characteristics of each participant and by observing the overload principle and the progression in the number of repetitions of each set during the 4 weeks of the improvement phase. The exercises will be performed from five sets of ten repetitions to six sets of 15 repetitions . Maintenance phase exercises:The exercises are the same as in the improvement phase without any progression in intensity and frequency. The maintenance phase duration is 2 weeks | Other | cervicothoracic mobilization, control group: comprehensive corrective exercise (CCE). |
Primary outcome
change in Craniovertebral angle (CVA) .
Time frame: before treatment,and after eight weeks of treatment.
Craniovertebral angle (CVA) will be measured using Computerized photogrammetry is utilized markers, Digital camera and Kinovea software.
change in Sagittal shoulder angle (SSA).
Time frame: before treatment,and after eight weeks of treatment.
Sagittal shoulder angle (SSA) will be measured using Computerized photogrammetry is utilized markers, Digital camera and Kinovea software.
change in thoracic kyphosis angle.
Time frame: before treatment,and after eight weeks of treatment.
thoracic kyphosis angle will be measured using the flexicurve ruler
change in pain level
Time frame: before treatment,and after eight weeks of treatment.
pain severity will be measured using visual analogue scale Each participant will be asked to put a mark on a 10-cm horizontal line that is marked with 'zero' at one end to indicate no pain and marked with'10' at the other end to indicate maximum pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 33244045Seidi F, Bayattork M, Minoonejad H, Andersen LL, Page P. Comprehensive corrective exercise program improves alignment, muscle activation and movement pattern of men with upper crossed syndrome: randomized controlled trial. Sci Rep. 2020 Nov 26;10(1):20688. doi: 10.1038/s41598-020-77571-4.
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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.
Abeer Yamany, professor study chair
Professor of physical therapy, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing cervicothoracic mobilization and CCE in people with Upper Crossed 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 5 inclusion and 9 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 11 Apr 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 Reem M El-kaffas, ass lecturer (01124434473, reem_elqaffas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Craniovertebral angle (CVA) . (time frame: before treatment,and after eight weeks of treatment.). 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 NCT05665296, which also lists 1 linked publication.
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 11 Apr 2023.