Neck PainNCT05636462
Global Postural Re-education Program on Neck Pain in Breast Feeding Females.
A study testing Global postural re-education program and Conventional Physical Therapy in people with Neck Pain and Disability Physical, run by Riphah International University at 1 site in Pakistan.
Trial summary
The significance of this study is that it will add to the growing body of knowledge that if these techniques yield outcomes in treatment of neck pain in breast feeding mothers. This study will add the beneficial effects to treat the neck pain in breast feeding females. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Neck Pain, Disability Physical, Breast Feeding
- What is being tested?
- Global postural re-education program and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2022to 15 Mar 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-35 Years
- Mothers who have pain score of 4 in NPRS
- Mothers who breast feed their babies
- Post-partum period
Who cannot join
- Neck pain due to any other comorbidity e.g. Previous history of trauma or fracture, disc prolapse, facet joint stenosis
- Previously kyhoscoliotic mothers
- Females who have C-section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Global Postural Re-education Program on Neck Pain and Disability in Breast Feeding Females.
The significance of this study is that it will add to the growing body of knowledge that if these techniques yield outcomes in treatment of neck pain in breast feeding mothers. This study will add the beneficial effects to treat the neck pain in breast feeding females.
Read the detailed description
Nonspecific neck pain is an increasingly frequent musculoskeletal condition affecting 22% to 70% of the population that is more prevalent in women than in men. Some patients will not experience complete resolution of pain and disability which can become a more complex chronic pain syndrome.(2) When symptoms persist for more than 12 weeks, the condition acquires the value of chronicity and is denominated chronic nonspecific neck pain. This is associated with high costs for public health, and is becoming a socio-health problem.
The mechanisms underlying recurrence or persistence of neck pain may be associated with biomechanical, functional, proprioceptive, and postural changes. However, the multidimensional nature of neck pain can involve not only the sensory-motor component, but also psychosocial components, such as anxiety, depression, and fear and catastrophic thoughts in response to pain (kinesiophobia and pain catastrophizing).
In 2018, a study is conducted on the effect of global postural reeducation in patients with chronic nonspecific neck pain and their study suggested that global postural reeducation shows promising results for the improvement of neck pain and disability in patients with chronic neck pain.
In 2016, a randomized controlled trial is conducted on Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain The result of the study showed that global postural reeducation , when provided in the absence of other intervention, can significantly decrease pain Pain intensity , disability and increases cervical range of motion.
In 2015, a research is conducted to find out the effects in short and long term of global postural reeducation (GPR) on chronic low back pain the result showed that global postural reeducation is effective in the treatment of low back pain and function this study, suggests that postural reeducation was highly effective in managing pain and function due to low back.
Although quite a number of researches have been done regarding more effective treatment of neck pain, there are actually no research in effect of postural re-education is seen in breast feeding females.
- Conditions
- Neck Pain, Disability Physical, Breast Feeding
- Being tested
- Global postural re-education program, Conventional Physical Therapy
- Medical subject headings
- Neck Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global postural re-education programOther
Different postures of global re-education programs are used and stretch is applied in these postures.
3 sessions per week are given and each session time is 40 minutes. Treatment is given for 4 weeks.
Conventional Physical TherapyOther
Isometrics and stretching is used as conventional treatment. 3 sessions per week are given and each session time is 40 minutes. Treatment is given for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Global postural re-education | Experimental | It consists of 27 patients who will receive conventional exercises and global postural re-education which will be divided in three components First in lying posture to stretch anterior muscles of neck for 15 min, second component in supine position and stretching posterior muscles for 15 min and final component is in standing position under a load of gravity for 5 min for 3 days a week . Receives: Other: Global postural re-education program |
| Conventional Physical therapy | Active comparator | It consists of 27 patients who will receive conventional therapy including stretching and strengthening exercises of neck for 3 days a week. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni dimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. Validity 0.86 to 0.95
Measured: 4th day
Neck Disability Index
The most used neck disability questionnaires are the Neck Pain and Disability scale (NPAD) and the Neck Disability Index (NDI) The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability,reliability between 0,50 and 0,98
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start5 Jan 2022
- Primary completion25 Jan 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeela Arif, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636462
- Sponsor's protocol ID
- Feryal Arshad
- Status last verified
- Jun 2023
- First submitted
- 24 Nov 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
PubMed 34682453Somarajan S, Hingarajia D. Effect of Global Postural Re-Education and Static Stretching on Pain and Disability in Women with Chronic Non-Specific Neck Pain-A Comparative Study. Indian Journal of Public Health Research & Development. 2021;12
Cavalcanti IF, Antonino GB, Monte-Silva KKD, Guerino MR, Ferreira APL, das Gracas Rodrigues de Araujo M. Global Postural Re-education in non-specific neck and low back pain treatment: A pilot study. J Back Musculoskelet Rehabil. 2020;33(5):823-828. doi: 10.3233/BMR-181371.
PubMed 31929138
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Global Postural Re-education Program on Neck Pain and Disability in Breast Feeding Females.
- ClinicalTrials.gov ID
- NCT05636462
- Acronym / sponsor ID
- Feryal Arshad
- Conditions
- Neck Pain, Disability Physical, Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 5 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.
The significance of this study is that it will add to the growing body of knowledge that if these techniques yield outcomes in treatment of neck pain in breast feeding mothers. This study will add the beneficial effects to treat the neck pain in breast feeding females.
Detailed description
Nonspecific neck pain is an increasingly frequent musculoskeletal condition affecting 22% to 70% of the population that is more prevalent in women than in men. Some patients will not experience complete resolution of pain and disability which can become a more complex chronic pain syndrome.(2) When symptoms persist for more than 12 weeks, the condition acquires the value of chronicity and is denominated chronic nonspecific neck pain. This is associated with high costs for public health, and is becoming a socio-health problem.
The mechanisms underlying recurrence or persistence of neck pain may be associated with biomechanical, functional, proprioceptive, and postural changes. However, the multidimensional nature of neck pain can involve not only the sensory-motor component, but also psychosocial components, such as anxiety, depression, and fear and catastrophic thoughts in response to pain (kinesiophobia and pain catastrophizing).
In 2018, a study is conducted on the effect of global postural reeducation in patients with chronic nonspecific neck pain and their study suggested that global postural reeducation shows promising results for the improvement of neck pain and disability in patients with chronic neck pain.
In 2016, a randomized controlled trial is conducted on Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain The result of the study showed that global postural reeducation , when provided in the absence of other intervention, can significantly decrease pain Pain intensity , disability and increases cervical range of motion.
In 2015, a research is conducted to find out the effects in short and long term of global postural reeducation (GPR) on chronic low back pain the result showed that global postural reeducation is effective in the treatment of low back pain and function this study, suggests that postural reeducation was highly effective in managing pain and function due to low back.
Although quite a number of researches have been done regarding more effective treatment of neck pain, there are actually no research in effect of postural re-education is seen in breast feeding females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global postural re-education | Experimental | Other: Global postural re-education programIt consists of 27 patients who will receive conventional exercises and global postural re-education which will be divided in three components First in lying posture to stretch anterior muscles of neck for 15 min, second component in supine position and stretching posterior muscles for 15 min and final component is in standing position under a load of gravity for 5 min for 3 days a week . |
| Conventional Physical therapy | Active comparator | Other: Conventional Physical TherapyIt consists of 27 patients who will receive conventional therapy including stretching and strengthening exercises of neck for 3 days a week. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 25-35 Years
- Mothers who have pain score of 4 in NPRS
- Mothers who breast feed their babies
- Post-partum period
Key exclusion criteria (3 listed)
- Neck pain due to any other comorbidity e.g. Previous history of trauma or fracture, disc prolapse, facet joint stenosis
- Previously kyhoscoliotic mothers
- Females who have C-section
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 |
|---|---|---|
| Global postural re-education programDifferent postures of global re-education programs are used and stretch is applied in these postures. 3 sessions per week are given and each session time is 40 minutes. Treatment is given for 4 weeks. | Other | Global postural re-education |
| Conventional Physical TherapyIsometrics and stretching is used as conventional treatment. 3 sessions per week are given and each session time is 40 minutes. Treatment is given for 4 weeks. | Other | Conventional Physical therapy |
Primary outcome
Neck pain
Time frame: 4th day
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a uni dimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. Validity 0.86 to 0.95
Neck Disability Index
Time frame: 4th day
The most used neck disability questionnaires are the Neck Pain and Disability scale (NPAD) and the Neck Disability Index (NDI) The Neck Pain and Disability scale (NPAD) is a composite index including 20 items which measure the intensity of neck pain and related disability,reliability between 0,50 and 0,98
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 15 Jun 2023.
- Background: PubMed 34682453Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
- BackgroundSomarajan S, Hingarajia D. Effect of Global Postural Re-Education and Static Stretching on Pain and Disability in Women with Chronic Non-Specific Neck Pain-A Comparative Study. Indian Journal of Public Health Research & Development. 2021;12
- Background: PubMed 31929138Cavalcanti IF, Antonino GB, Monte-Silva KKD, Guerino MR, Ferreira APL, das Gracas Rodrigues de Araujo M. Global Postural Re-education in non-specific neck and low back pain treatment: A pilot study. J Back Musculoskelet Rehabil. 2020;33(5):823-828. doi: 10.3233/BMR-181371.
- 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.
Adeela Arif, Mphil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global postural re-education program and Conventional Physical Therapy in people with Neck Pain and Disability Physical, 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 4 inclusion and 3 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 15 Jun 2023. 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?
Neck pain (time frame: 4th day). The study lists 2 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 NCT05636462, which also lists 3 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 15 Jun 2023.