- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665296
Effect of Cervicothoracic Mobilization on Upper Crossed Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reem M El-kaffas, ass lecturer
- Phone Number: 01124434473
- Email: reem_elqaffas@yahoo.com
Study Contact Backup
- Name: Abeer Yamany, professor
- Phone Number: 01006899872
- Email: abeer.yamany@pt.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- pregnancy.
- Being in weight out of the normal range (18 ≥ BMI ≥ 25).
- Cognitive impairment and inability to understand the scale.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cervicothoracic mobilization
This group will receive cervicothoracic mobilization with comprehensive corrective exercise
|
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.
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 |
Active Comparator: control group: comprehensive corrective exercise (CCE).
This group will receive traditional treatment comprehensive corrective exercise (CCE).
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
before treatment,and after eight weeks of treatment.
|
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.
|
before treatment,and after eight weeks of treatment.
|
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
|
before treatment,and after eight weeks of treatment.
|
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.
|
before treatment,and after eight weeks of treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Abeer Yamany, professor, Professor of physical therapy, Cairo University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003840
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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