Upper Cross SyndromeNCT06302972
Effects of IASTM Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome.
A study testing Traditional treatment and IASTM and CCEP in people with Upper Cross Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Upper Cross Syndrome
- What is being tested?
- Traditional treatment and IASTM and CCEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2023to 30 Jun 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years.
- Diagnosed patients with the upper crossed syndrome who have chronic neck
- pain for more than 3 months.
- Having neck pain scoring more than 3 on the Numeric Pain Scale were included
- in this study.
- Any abnormality in the position and rhythm of the scapula, as measured by the Scapular dyskinesis test, having postural changes such as excessive thoracic kyphosis (≥42°), forward head (≥44°) or round shoulder (≥49°) as measured by Flexicurve and photogrammetry.
- Both male and female population will be included
Who cannot join
- The subjects with any previous surgery, any type of Infection Hypersensitive skin Diabetes Mellitus type II Having Traumatic Injury Psychological disorder Manual Therapy contraindication like osteoporosis, infection, Disc- Herniation acute Inflammation, burn scars, closed /non-complicated fractures and open wound.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Maroof international Hospital and Railway Hospital
Islamabad, Federal, 44000
About this study
Official title: Effects of Instrument Assisted Soft Tissue Mobilization Technique Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome.
This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results.
Read the detailed description
The upper cross syndrome involves stiffness of levator scapulae, pectoralis major and upper trapezius muscles and serratus anterior, deep neck flexors, rhomboids, middle and lower trapezius and scalene muscles weakness. Numerous bodily abnormalities such as headache, early deterioration of cervical spine and loss of cervical spine curve can be brought on by this syndrome. This syndrome can also result in thoracic spine abnormality and impaired glenohumeral joint biomechanics. Upper cross syndrome develops abnormality in head, neck and shoulder and develops in upper 1⁄4 of the trunk. The underlying causative agents of Upper cross syndrome are long surgeries, weakness, female gender, disability and poor posture. It was a randomized, controlled trial, conducted among patient with upper cross syndrome with Sample size was 44 by using G- Power software. Group A will be given IASTM with Graston's tool and comprehensive corrective exercise program and Group B will receive only comprehensive corrective exercise program. The protocol will consist of 12 sessions in total with 3 sessions a week 45 minutes / session for both groups. Assessment will be at baseline then after 2 weeks after that 2 weeks home plan for exercises and then after 4 weeks assessment will be done. Only pain will be assessed on alternative days
- Conditions
- Upper Cross Syndrome
- Being tested
- Traditional treatment, IASTM and CCEP
- Keywords
- Forward head angle, Pain, ROM, Rounded Shoulder
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional treatmentOther
Hot Pack will be applied at the beginning of the session for 10 minutes. Wall corner stretching exercises, neck isometric exercises and neck stretching exercises will be performed Cold pack will be applied at the end of the session for a few minutes.
IASTM and CCEPOther
Instrument Assisted Soft Mobilization Technique (IASTM); For pectoralis major:
Subjects will be asked to lay supine with their thorax front side exposed. In abduction, restriction or adhesions will be located using scanning and gel will be applied. IASTM also address soft tissue restrictions and pain in levator scapulae, suboccipital muscles and sternocleidomastoid muscle.
The Comprehensive Corrective Exercise Program (CCEP) will be designed in three phases, including initial, improvement, and maintenance.. The exercises in appropriate muscles in correct alignment during the movement pattern, the protocol focused on improving sustained postures.
Exercises in initial phase protocol from 10 s hold x7 to 15 s hold x 10 from roller Exercises in improvement phase protocol from 10 repetition x 5 to 15 repetition x 6 from dumbbell , thera band, swiss ball and balance board
| Study group | Role | What they receive |
|---|---|---|
| IASTM and CCEP | Experimental | Instrument Assisted Soft Mobilization Technique; For pectoralis major:
Subjects will be asked to lay supine with their thorax front side exposed. In abduction, restriction or adhesions will be located using scanning and gel will be applied. IASTM also address soft tissue restrictions and pain in levator scapulae, suboccipital muscles and sternocleidomastoid muscle.
The CCEP will be designed in three phases, including initial, improvement, and maintenance.. The exercises in appropriate muscles in correct alignment during the movement pattern, the protocol focused on improving sustained postures.
Exercises in initial phase protocol from 10 s hold x7 to 15 s hold x 10 from roller Exercises in improvement phase protocol from 10 repetition x 5 to 15 repetition x 6 from dumbbell , thera band, swiss ball and balance board Receives: Other: IASTM and CCEP |
| Comprehensive Corrective Exercise Program.Type | Active comparator | The CCEP will be designed in three phases, including initial, improvement, and maintenance. Exercises are progressed in frequency and intensity during these phases, as long as the movements are performed in a good quality. The exercises in appropriate muscles in correct alignment during the movement pattern, the protocol focused on improving sustained postures. This goal was addressed in the improvement phase when necessary tissue adaptations occurred by increasing the load of exercises. In the maintenance phase, the participant continued to do the exercises and maintain the training adaptations for two weeks. The exercises will be the same as the improvement phase without any progression in intensity and frequency.
Exercises in initial phase protocol from 10 s hold x7 to 15 s hold x 10 from roller Exercises in improvement phase protocol from 10 repetition x 5 to 15 repetition x 6 from dumbbell , thera band, swiss ball and balance board Receives: Other: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion Cervical (Flexion)
Changes from baseline,2nd week, 4th week ROM range of motion of cervical flexion was taken
Measured: 4 week
ROM Cervical (Extension)
Changes from baseline,2nd week, 4th week ROM range of motion of cervical extension was taken
Measured: 4 Week
ROM Cervical (Left Lateral Flexion)
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Left Lateral Flexion was taken
Measured: 4 week
ROM Cervical( Right Lateral Flexion)
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Right Lateral flexion was taken with the help of bubble Inclinometer
Measured: 4 week
ROM Cervical ( Right Rotation)
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Right Rotation was taken
Measured: 4 week
ROM Cervical ( Left Rotation)
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Left Rotation was taken.
Measured: 4 week
Secondary outcomes (2)
Numeric Pain Rating Scale (NPRS)
NPRS is used for pain assessment. Pain assessment will be at baseline and in week one on alternative days and then after 2nd, 3rd and 4th weeks pain will be assessed on alternative days.
Measured: 4 week
Flexicurve Ruler and Photogrammetry for posture
Excessive thoracic kyphosis, forward head or round shoulder as measured by Flexicurve and photogrammetry. For posture correction assessment will be at baseline and then after 2 weeks and then after 4 weeks.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Cross 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
- Model description
- Participants were randomly assigned to the experimental group or control group after a baseline assessment with sealed enveloped method. Each participant took a envelope that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Ishtiaq, MSOMPT, Principal investigator, Riphah International university Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302972
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/01771
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dehdilani M, Gol MK, Hashemzadeh K. Effects of Stretching Exercises on Upper Crossed Syndrome in Women after a Coronary Artery Bypass Graft. Crescent Journal of Medical & Biological Sciences. 2019 Jul 1;6(3).
Mahmood T, Afzal MW, Waseem I, Arif MA, Mahmood W. Comparative Effectiveness of Routine Physical Therapy with and without Instrument Assisted Soft Tissue Mobilization for Improving Pain and Disability in Patients with Neck Pain Due to Upper Crossed Syndrome. Annals of Punjab Medical College (APMC). 2022 Mar 31;16(1):45-50.
Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.
PubMed 22034615Gull M, Akbar UU, Asim HM. FREQUENCY OF CHRONIC NECK PAIN IN UPPER CROSS SYNDROME IN FEMALE SCHOOL TEACHERS. Independent Journal of Allied Health Sciences. 2018;1(01):33-8.
Ali S, Ahmad S, Jalal Y, Shah B. Effectiveness of Stretching Exercises Versus Muscle Energy Techniques in the Management of Upper Cross Syndrome: JRCRS. 2017; 5 (1): 12-16. Journal Riphah College of Rehabilitation Sciences. 2017 Mar 10;5(1):12-6.
El-Hafez HM, Hamdy HA, Takla MK, Ahmed SEB, Genedy AF, Abd El-Azeim ASS. Instrument-assisted soft tissue mobilisation versus stripping massage for upper trapezius myofascial trigger points. J Taibah Univ Med Sci. 2020 Mar 6;15(2):87-93. doi: 10.1016/j.jtumed.2020.01.006. eCollection 2020 Apr.
PubMed 32368203Seidi 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument Assisted Soft Tissue Mobilization Technique Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome.
- ClinicalTrials.gov ID
- NCT06302972
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/01771
- Conditions
- Upper Cross Syndrome
- Keywords
- Forward head angle, Pain, ROM, Rounded Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (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 see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results.
Detailed description
The upper cross syndrome involves stiffness of levator scapulae, pectoralis major and upper trapezius muscles and serratus anterior, deep neck flexors, rhomboids, middle and lower trapezius and scalene muscles weakness. Numerous bodily abnormalities such as headache, early deterioration of cervical spine and loss of cervical spine curve can be brought on by this syndrome. This syndrome can also result in thoracic spine abnormality and impaired glenohumeral joint biomechanics. Upper cross syndrome develops abnormality in head, neck and shoulder and develops in upper 1⁄4 of the trunk. The underlying causative agents of Upper cross syndrome are long surgeries, weakness, female gender, disability and poor posture. It was a randomized, controlled trial, conducted among patient with upper cross syndrome with Sample size was 44 by using G- Power software. Group A will be given IASTM with Graston's tool and comprehensive corrective exercise program and Group B will receive only comprehensive corrective exercise program. The protocol will consist of 12 sessions in total with 3 sessions a week 45 minutes / session for both groups. Assessment will be at baseline then after 2 weeks after that 2 weeks home plan for exercises and then after 4 weeks assessment will be done. Only pain will be assessed on alternative days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to the experimental group or control group after a baseline assessment with sealed enveloped method. Each participant took a envelope that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to.
| Arm | Type | Receives |
|---|---|---|
| IASTM and CCEP | Experimental | Other: IASTM and CCEPInstrument Assisted Soft Mobilization Technique; For pectoralis major: Subjects will be asked to lay supine with their thorax front side exposed. In abduction, restriction or adhesions will be located using scanning and gel will be applied. IASTM also address soft tissue restrictions and pain in levator scapulae, suboccipital muscles and sternocleidomastoid muscle. The CCEP will be designed in three phases, including initial, improvement, and maintenance.. The exercises in appropriate muscles in correct alignment during the movement pattern, the protocol focused on improving sustained postures. Exercises in initial phase protocol from 10 s hold x7 to 15 s hold x 10 from roller Exercises in improvement phase protocol from 10 repetition x 5 to 15 repetition x 6 from dumbbell , thera band, swiss ball and balance board |
| Comprehensive Corrective Exercise Program.Type | Active comparator | Other: Traditional treatmentThe CCEP will be designed in three phases, including initial, improvement, and maintenance. Exercises are progressed in frequency and intensity during these phases, as long as the movements are performed in a good quality. The exercises in appropriate muscles in correct alignment during the movement pattern, the protocol focused on improving sustained postures. This goal was addressed in the improvement phase when necessary tissue adaptations occurred by increasing the load of exercises. In the maintenance phase, the participant continued to do the exercises and maintain the training adaptations for two weeks. The exercises will be the same as the improvement phase without any progression in intensity and frequency. Exercises in initial phase protocol from 10 s hold x7 to 15 s hold x 10 from roller Exercises in improvement phase protocol from 10 repetition x 5 to 15 repetition x 6 from dumbbell , thera band, swiss ball and balance board |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-40 years.
- Diagnosed patients with the upper crossed syndrome who have chronic neck
- pain for more than 3 months.
- Having neck pain scoring more than 3 on the Numeric Pain Scale were included
- in this study.
Key exclusion criteria (1 listed)
- The subjects with any previous surgery, any type of Infection Hypersensitive skin Diabetes Mellitus type II Having Traumatic Injury Psychological disorder Manual Therapy contraindication like osteoporosis, infection, Disc- Herniation acute Inflammation, burn scars, closed /non-complicated fractures and open wound.
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 |
|---|---|---|
| Traditional treatmentHot Pack will be applied at the beginning of the session for 10 minutes. Wall corner stretching exercises, neck isometric exercises and neck stretching exercises will be performed Cold pack will be applied at the end of the session for a few minutes. | Other | Comprehensive Corrective Exercise Program.Type |
| IASTM and CCEPInstrument Assisted Soft Mobilization Technique (IASTM); For pectoralis major: Subjects will be asked to lay supine with their thorax front side exposed. In abduction, restriction or adhesions will be located using scanning and gel will be applied. IASTM also address soft tissue restrictions and pain in levator scapulae, suboccipital muscles and sternocleidomastoid muscle. The Comprehensive Corrective Exercise Program (CCEP) will be designed in three phases, including initial, improvement, and maintenance.. The exercises in appropriate muscles in correct alignment during the movement pattern, the protocol focused on improving sustained postures. Exercises in initial phase protocol from 10 s hold x7 to 15 s hold x 10 from roller Exercises in improvement phase protocol from 10 repetition x 5 to 15 repetition x 6 from dumbbell , thera band, swiss ball and balance board | Other | IASTM and CCEP |
Primary outcome
Range of motion Cervical (Flexion)
Time frame: 4 week
Changes from baseline,2nd week, 4th week ROM range of motion of cervical flexion was taken
ROM Cervical (Extension)
Time frame: 4 Week
Changes from baseline,2nd week, 4th week ROM range of motion of cervical extension was taken
ROM Cervical (Left Lateral Flexion)
Time frame: 4 week
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Left Lateral Flexion was taken
ROM Cervical( Right Lateral Flexion)
Time frame: 4 week
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Right Lateral flexion was taken with the help of bubble Inclinometer
ROM Cervical ( Right Rotation)
Time frame: 4 week
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Right Rotation was taken
ROM Cervical ( Left Rotation)
Time frame: 4 week
Changes from baseline,2nd week, 4th week ROM range of motion of Cervical Left Rotation was taken.
2 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: 4 week
Flexicurve Ruler and Photogrammetry for posture
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- BackgroundDehdilani M, Gol MK, Hashemzadeh K. Effects of Stretching Exercises on Upper Crossed Syndrome in Women after a Coronary Artery Bypass Graft. Crescent Journal of Medical & Biological Sciences. 2019 Jul 1;6(3).
- BackgroundMahmood T, Afzal MW, Waseem I, Arif MA, Mahmood W. Comparative Effectiveness of Routine Physical Therapy with and without Instrument Assisted Soft Tissue Mobilization for Improving Pain and Disability in Patients with Neck Pain Due to Upper Crossed Syndrome. Annals of Punjab Medical College (APMC). 2022 Mar 31;16(1):45-50.
- Background: PubMed 22034615Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.
- BackgroundGull M, Akbar UU, Asim HM. FREQUENCY OF CHRONIC NECK PAIN IN UPPER CROSS SYNDROME IN FEMALE SCHOOL TEACHERS. Independent Journal of Allied Health Sciences. 2018;1(01):33-8.
- BackgroundAli S, Ahmad S, Jalal Y, Shah B. Effectiveness of Stretching Exercises Versus Muscle Energy Techniques in the Management of Upper Cross Syndrome: JRCRS. 2017; 5 (1): 12-16. Journal Riphah College of Rehabilitation Sciences. 2017 Mar 10;5(1):12-6.
- Background: PubMed 32368203El-Hafez HM, Hamdy HA, Takla MK, Ahmed SEB, Genedy AF, Abd El-Azeim ASS. Instrument-assisted soft tissue mobilisation versus stripping massage for upper trapezius myofascial trigger points. J Taibah Univ Med Sci. 2020 Mar 6;15(2):87-93. doi: 10.1016/j.jtumed.2020.01.006. eCollection 2020 Apr.
- 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.
- 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.
Nadia Ishtiaq, MSOMPT principal investigator
Riphah International university Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional treatment and IASTM and CCEP in people with Upper Cross 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 7 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 19 Apr 2024. 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 Rida Alam, MSOMPT (03359635579, nadia.ishtiaq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion Cervical (Flexion) (time frame: 4 week). The study lists 6 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 NCT06302972, which also lists 7 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 19 Apr 2024.