UPPER CROSS SYNDROMENCT06303102
Effects of Segmental and Pursed Lip Breathing Exercises on Upper Cross Syndrome
A study testing Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise and Manual PT/Conventional PT Treatment in people with UPPER CROSS SYNDROME, run by Riphah International University at 1 site in Pakistan.
Trial summary
Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- UPPER CROSS SYNDROME
- What is being tested?
- Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise and Manual PT/Conventional PT Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 23 May 2023to 15 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both Gender >25-40 years
- Diagnosed with Upper Cross Syndrome, having neck pain intensity more than 5 on numeric pain rating scale and having pain from more than 3 months
- Positive Janda cervical flexion Test
Who cannot join
- Patient with other musculoskeletal disorder e.g cervicogenic headache excluded
- Neck pain with whiplash or headache disorder were not included
- Patients had any history of previous head and neck surgery excluded
- Any history of Infection in the cervical spine were not included
- Trigger points of trapezius were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Segmental and Pursed Lip Breathing Exercises on Neck Pain, Functional Disability and Quality of Life in Upper Cross Syndrome
Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. Neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. The aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome.
Current study will be randomized controlled trial conducted at Ismail Medicare Jhang, 40 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) while Group B (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. Outcome measures are Pain Numeric Scale, Quality of life (SF 36) and Functional disability (neck disability index). These tools will measure neck function and neck pain intensity. Treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. Data will be analyzed by SPSS version 25. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis.
Key Words: Breathing Exercises, Cervical Pain, Disability, Upper Cross
- Conditions
- UPPER CROSS SYNDROME
- Being tested
- Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise, Manual PT/Conventional PT Treatment
- Keywords
- Breathing Exercises, Cervical Pain, Disability, Upper Cross Syndrome
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing ExerciseOther
20 patients will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) along with segmental and pursed lip breathing exercises.
Manual PT/Conventional PT TreatmentOther
20 patients will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental Group A (Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise) Receives: Other: Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise |
| Controlled | Other | Group B (Manual PT/Conventional PT Treatment) Receives: Other: Manual PT/Conventional PT Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
An outcome measure used to gauge adult pain intensity is the Numeric Pain Rating Scale (NPRS). "No pain" is represented by a score of '0' on the11-point numeric scale, while "pain as bad as you can imagine" or "worst pain imaginable" are represented by a score of '10'. An 11-point numerical scale goes from '0', which indicates no discomfort, to 10 symbolizing the most excruciating agony conceivable. Pre-post readings will be taken
Measured: 4 Weeks
Quality of Life (SF-36 questionnaire)
The Short Form Survey (SF-36) is a tool used to measure various aspects of quality of life, such as body pain, physical well-being or functionality. Restrictions on role performance brought on by issues with one's physical, mental, or social well-being as well as one's general sense of health. Pre-post readings will be taken.
Measured: 4 Weeks
Neck Disability Index (NDI)
The Oswestry Low Back Pain Disability Index was modified to create the Neck Disability Index (NDI). The purpose of this questionnaire is to gather information on how your neck pain has impacted your day-to-day functioning. The NDI is now a commonly used tool to assess neck pain-related self-rated disability. All ten items have a score ranging from 0 to 5. The purpose of this questionnaire is to gather information on how your neck pain has impacted your day-to-day functioning. The NDI is now a commonly used tool to assess neck pain-related self-rated disability. All ten items have a score ranging from 0 to 5. Pre-post readings will be taken.
Measured: 4 Weeks
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 start23 May 2023
- Primary completion30 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UPPER CROSS SYNDROMEStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Muriam Ghani, MSCPPT, Principal investigator, Ripha International University-LHR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303102
- Sponsor's protocol ID
- REC/RCR&AHS/23/0356
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baradaran Mahdavi S, Riahi R, Vahdatpour B, Kelishadi R. Association between sedentary behavior and low back pain; A systematic review and meta-analysis. Health Promot Perspect. 2021 Dec 19;11(4):393-410. doi: 10.34172/hpp.2021.50. eCollection 2021.
PubMed 35079583Csepregi E, Gyurcsik Z, Veres-Balajti I, Nagy AC, Szekanecz Z, Szanto S. Effects of Classical Breathing Exercises on Posture, Spinal and Chest Mobility among Female University Students Compared to Currently Popular Training Programs. Int J Environ Res Public Health. 2022 Mar 21;19(6):3728. doi: 10.3390/ijerph19063728.
PubMed 35329415de-la-Iglesia L, Bravo C, Rubi-Carnacea F. Upper crossed syndrome in secondary school students: A mixed-method study. J Taibah Univ Med Sci. 2023 Jan 24;18(4):894-907. doi: 10.1016/j.jtumed.2023.01.008. eCollection 2023 Aug.
PubMed 36852233Ghan GM, Babu VS. Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial. J Man Manip Ther. 2021 Jun;29(3):147-157. doi: 10.1080/10669817.2020.1834321. Epub 2020 Oct 22.
PubMed 33090945Arshadi R, Ghasemi GA, Samadi H. Effects of an 8-week selective corrective exercises program on electromyography activity of scapular and neck muscles in persons with upper crossed syndrome: Randomized controlled trial. Phys Ther Sport. 2019 May;37:113-119. doi: 10.1016/j.ptsp.2019.03.008. Epub 2019 Mar 21.
PubMed 30928841Mujawar JC, Sagar JH. Prevalence of Upper Cross Syndrome in Laundry Workers. Indian J Occup Environ Med. 2019 Jan-Apr;23(1):54-56. doi: 10.4103/ijoem.IJOEM_169_18.
PubMed 31040591
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Segmental and Pursed Lip Breathing Exercises on Neck Pain, Functional Disability and Quality of Life in Upper Cross Syndrome
- ClinicalTrials.gov ID
- NCT06303102
- Acronym / sponsor ID
- REC/RCR&AHS/23/0356
- Conditions
- UPPER CROSS SYNDROME
- Keywords
- Breathing Exercises, Cervical Pain, Disability, Upper Cross Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- 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.
Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. Neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. The aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome.
Current study will be randomized controlled trial conducted at Ismail Medicare Jhang, 40 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) while Group B (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. Outcome measures are Pain Numeric Scale, Quality of life (SF 36) and Functional disability (neck disability index). These tools will measure neck function and neck pain intensity. Treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. Data will be analyzed by SPSS version 25. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis.
Key Words: Breathing Exercises, Cervical Pain, Disability, Upper Cross
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing ExerciseExperimental Group A (Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise) |
| Controlled | Other | Other: Manual PT/Conventional PT TreatmentGroup B (Manual PT/Conventional PT Treatment) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both Gender >25-40 years
- Diagnosed with Upper Cross Syndrome, having neck pain intensity more than 5 on numeric pain rating scale and having pain from more than 3 months
- Positive Janda cervical flexion Test
Key exclusion criteria (5 listed)
- Patient with other musculoskeletal disorder e.g cervicogenic headache excluded
- Neck pain with whiplash or headache disorder were not included
- Patients had any history of previous head and neck surgery excluded
- Any history of Infection in the cervical spine were not included
- Trigger points of trapezius were excluded
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 |
|---|---|---|
| Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise20 patients will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) along with segmental and pursed lip breathing exercises. | Other | Experimental |
| Manual PT/Conventional PT Treatment20 patients will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises). | Other | Controlled |
Primary outcome
NPRS
Time frame: 4 Weeks
An outcome measure used to gauge adult pain intensity is the Numeric Pain Rating Scale (NPRS). "No pain" is represented by a score of '0' on the11-point numeric scale, while "pain as bad as you can imagine" or "worst pain imaginable" are represented by a score of '10'. An 11-point numerical scale goes from '0', which indicates no discomfort, to 10 symbolizing the most excruciating agony conceivable. Pre-post readings will be taken
Quality of Life (SF-36 questionnaire)
Time frame: 4 Weeks
The Short Form Survey (SF-36) is a tool used to measure various aspects of quality of life, such as body pain, physical well-being or functionality. Restrictions on role performance brought on by issues with one's physical, mental, or social well-being as well as one's general sense of health. Pre-post readings will be taken.
Neck Disability Index (NDI)
Time frame: 4 Weeks
The Oswestry Low Back Pain Disability Index was modified to create the Neck Disability Index (NDI). The purpose of this questionnaire is to gather information on how your neck pain has impacted your day-to-day functioning. The NDI is now a commonly used tool to assess neck pain-related self-rated disability. All ten items have a score ranging from 0 to 5. The purpose of this questionnaire is to gather information on how your neck pain has impacted your day-to-day functioning. The NDI is now a commonly used tool to assess neck pain-related self-rated disability. All ten items have a score ranging from 0 to 5. Pre-post readings will be taken.
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 12 Mar 2024.
- Background: PubMed 35079583Baradaran Mahdavi S, Riahi R, Vahdatpour B, Kelishadi R. Association between sedentary behavior and low back pain; A systematic review and meta-analysis. Health Promot Perspect. 2021 Dec 19;11(4):393-410. doi: 10.34172/hpp.2021.50. eCollection 2021.
- Background: PubMed 35329415Csepregi E, Gyurcsik Z, Veres-Balajti I, Nagy AC, Szekanecz Z, Szanto S. Effects of Classical Breathing Exercises on Posture, Spinal and Chest Mobility among Female University Students Compared to Currently Popular Training Programs. Int J Environ Res Public Health. 2022 Mar 21;19(6):3728. doi: 10.3390/ijerph19063728.
- Background: PubMed 36852233de-la-Iglesia L, Bravo C, Rubi-Carnacea F. Upper crossed syndrome in secondary school students: A mixed-method study. J Taibah Univ Med Sci. 2023 Jan 24;18(4):894-907. doi: 10.1016/j.jtumed.2023.01.008. eCollection 2023 Aug.
- Background: PubMed 33090945Ghan GM, Babu VS. Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial. J Man Manip Ther. 2021 Jun;29(3):147-157. doi: 10.1080/10669817.2020.1834321. Epub 2020 Oct 22.
- Background: PubMed 30928841Arshadi R, Ghasemi GA, Samadi H. Effects of an 8-week selective corrective exercises program on electromyography activity of scapular and neck muscles in persons with upper crossed syndrome: Randomized controlled trial. Phys Ther Sport. 2019 May;37:113-119. doi: 10.1016/j.ptsp.2019.03.008. Epub 2019 Mar 21.
- Background: PubMed 31040591Mujawar JC, Sagar JH. Prevalence of Upper Cross Syndrome in Laundry Workers. Indian J Occup Environ Med. 2019 Jan-Apr;23(1):54-56. doi: 10.4103/ijoem.IJOEM_169_18.
- 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.
Hafiza Muriam Ghani, MSCPPT principal investigator
Ripha International University-LHR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise and Manual PT/Conventional PT Treatment 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 3 inclusion and 5 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 12 Mar 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?
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?
NPRS (time frame: 4 Weeks). The study lists 3 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 NCT06303102, which also lists 6 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 12 Mar 2024.