Back PainGPRNCT04555668
Effect of Global Postural Reeducation (GPR) Program With Hamstring Stretch for Patients With Low Back Pain
A study testing Global Postural Reeducation Program and Hamstring Stretch Program in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Back Pain
- What is being tested?
- Global Postural Reeducation Program and Hamstring Stretch Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2020to 1 Sep 2020
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females
- 18-35 years
- Low back pain > 3 month
- no exercise for last 6 months
Who cannot join
- Any diagnosed pathology (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis)
- Any lower limb abnormality
- Congenital deformities
- Central or peripheral neurologic signs
- Systemic illness (tumor and rheumatologic diseases),
- Psychiatric and mental deficits
- Diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping hand institute of rehabilitation sciences
Mānsehra, Khyber Pakhtunkhwa
About this study
Official title: Effect of Global Postural Reeducation Program With Hamstring Stretch for Patients With Low Back Pain
The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.
Read the detailed description
Low back pain (LBP) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. LBP is a complicated condition which affects the physiological and psychosocial aspects of the patient. The muscles of the low back provide the strength and mobility for all activities of daily living. The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.
- Conditions
- Back Pain
- Being tested
- Global Postural Reeducation Program, Hamstring Stretch Program
- Keywords
- Low Back Pain, Oswestry Disability Index, Numeric Pain Rating Scale, Stretch
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Postural Reeducation ProgramOther
Global Postural Reeducation Program with hamstring stretch The lying posture with flexion of the legs aimed to stretch the posterior chain (upper trapezius, levator scapulae, sub occipital, erector spinae, gluteus maximus, ischio-tibial, triceps surae, and foot intrinsic muscles). The initial position will lying with the hip flexed and progression consisted of increasing hip flexion, knee extension, and dorsiflexion of the ankle All above exercises will be given and to be held for 15 minutes each. 40 min/session, 3 times/week for 6 weeks
Hamstring Stretch ProgramOther
Hamstring Stretch Program 3 times for 30 seconds hold, subjects rested for 15 seconds between stretches. Knee -flexor eccentric training to prevent hamstring muscle strain 10-15 rep 40 min/session, 3 times/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Global Postural Reeducation Program | Experimental | Global Postural Reeducation Program with hamstring stretch Receives: Other: Global Postural Reeducation Program |
| Hamstring Stretch Program | Active comparator | Hamstring Stretch Program and Knee -flexor eccentric training Receives: Other: Hamstring Stretch Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5.
0% to 20%: minimal disability 81%-100% exaggerating symptoms.
Measured: 6th week
Numeric Pain Rating Scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pai
Measured: 6th week
Goniometry
A goniometer is an instrument which measures the available range of motion at a joint.
A large Universal Goniometer having 12-inch arms and full-circle plastic body will be used for measuring Assisted Range of Motion (AROM) for hamstring length, it is a useful measurement tool that can be used to do the Active knee extension test. An active knee-extension test has been shown to be a reliable method of assessing hamstring tightness and has good intra-tester reliability [intraclass correlation coefficient (ICC): 0.97-0.98]
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start15 Jan 2020
- Primary completion15 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Back 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazish Rafique, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555668
- Sponsor's protocol ID
- REC/00238 Maliha Iftikhar
- Acronym
- GPR
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuenca-Martinez F, Cortes-Amador S, Espi-Lopez GV. Effectiveness of classic physical therapy proposals for chronic non-specific low back pain: a literature review. Phys Ther Res. 2018 Mar 20;21(1):16-22. doi: 10.1298/ptr.E9937. eCollection 2018.
PubMed 30050749da Silva DA, de Carvalho MEIM, de Andrade Mesquita LS. Effects of a protocol with manual therapy and postural techniques for non-specific low back pain. Manual Therapy, Posturology & Rehabilitation Journal. 2019;17:0-.
Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
PubMed 19103627Parreira P, Maher CG, Steffens D, Hancock MJ, Ferreira ML. Risk factors for low back pain and sciatica: an umbrella review. Spine J. 2018 Sep;18(9):1715-1721. doi: 10.1016/j.spinee.2018.05.018. Epub 2018 May 21.
PubMed 29792997Bento TPF, Genebra CVDS, Maciel NM, Cornelio GP, Simeao SFAP, Vitta A. Low back pain and some associated factors: is there any difference between genders? Braz J Phys Ther. 2020 Jan-Feb;24(1):79-87. doi: 10.1016/j.bjpt.2019.01.012. Epub 2019 Feb 13.
PubMed 30782429Abu-Naser SS, ALDAHDOOH R. Lower back pain expert system diagnosis and treatment. 2016.
Krismer M, van Tulder M; Low Back Pain Group of the Bone and Joint Health Strategies for Europe Project. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007 Feb;21(1):77-91. doi: 10.1016/j.berh.2006.08.004.
PubMed 17350545Abdullah IB, Al-Mutairi MM, Alghubayan MA, Alamir AA, Bu-Jubarah AY, Almajed N, et al. Literature Review on Prevalence, Risk Factors and, Evaluation of Acute Lower Back Pain. International Journal of Pharmaceutical Research & Allied Sciences. 2020;9(1).
Manchikanti L. Epidemiology of low back pain. Pain Physician. 2000 Apr;3(2):167-92.
PubMed 16906196Brighton SW. The management of acute low back pain in adults: a guide for the primary care physician, Part II. South African Family Practice. 2013;55(1):26-32.
Paolucci T, Attanasi C, Cecchini W, Marazzi A, Capobianco SV, Santilli V. Chronic low back pain and postural rehabilitation exercise: a literature review. J Pain Res. 2018 Dec 20;12:95-107. doi: 10.2147/JPR.S171729. eCollection 2019.
PubMed 30588084van Tulder MW, Malmivaara A, Esmail R, Koes BW. Exercise therapy for low back pain. Cochrane Database Syst Rev. 2000;(2):CD000335. doi: 10.1002/14651858.CD000335.
PubMed 10796344Bonetti F, Curti S, Mattioli S, Mugnai R, Vanti C, Violante FS, Pillastrini P. Effectiveness of a 'Global Postural Reeducation' program for persistent low back pain: a non-randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 16;11:285. doi: 10.1186/1471-2474-11-285.
PubMed 21162726Guastala FAM, Guerini MH, Klein PF, Leite VC, Cappellazzo R, Facci LM. Effect of global postural re-education and isostretching in patients with nonspecific chronic low back pain: a randomized clinical trial. Fisioterapia em Movimento. 2016;29(3):515-25.
Mistry GS, Vyas NJ, Sheth MS. Comparison of hamstrings flexibility in subjects with chronic low back pain versus normal individuals. J Clin Exp Res. 2014;2(1):85-8.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Global Postural Reeducation Program With Hamstring Stretch for Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04555668
- Acronym / sponsor ID
- GPR / REC/00238 Maliha Iftikhar
- Conditions
- Back Pain
- Keywords
- Low Back Pain, Oswestry Disability Index, Numeric Pain Rating Scale, Stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 21 Sep 2020 (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 purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.
Detailed description
Low back pain (LBP) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. LBP is a complicated condition which affects the physiological and psychosocial aspects of the patient. The muscles of the low back provide the strength and mobility for all activities of daily living. The purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Global Postural Reeducation Program | Experimental | Other: Global Postural Reeducation ProgramGlobal Postural Reeducation Program with hamstring stretch |
| Hamstring Stretch Program | Active comparator | Other: Hamstring Stretch ProgramHamstring Stretch Program and Knee -flexor eccentric training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females
- 18-35 years
- Low back pain > 3 month
- no exercise for last 6 months
Key exclusion criteria (7 listed)
- Any diagnosed pathology (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis)
- Any lower limb abnormality
- Congenital deformities
- Central or peripheral neurologic signs
- Systemic illness (tumor and rheumatologic diseases),
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 Reeducation ProgramGlobal Postural Reeducation Program with hamstring stretch The lying posture with flexion of the legs aimed to stretch the posterior chain (upper trapezius, levator scapulae, sub occipital, erector spinae, gluteus maximus, ischio-tibial, triceps surae, and foot intrinsic muscles). The initial position will lying with the hip flexed and progression consisted of increasing hip flexion, knee extension, and dorsiflexion of the ankle All above exercises will be given and to be held for 15 minutes each. 40 min/session, 3 times/week for 6 weeks | Other | Global Postural Reeducation Program |
| Hamstring Stretch ProgramHamstring Stretch Program 3 times for 30 seconds hold, subjects rested for 15 seconds between stretches. Knee -flexor eccentric training to prevent hamstring muscle strain 10-15 rep 40 min/session, 3 times/week for 6 weeks | Other | Hamstring Stretch Program |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 6th week
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. 0% to 20%: minimal disability 81%-100% exaggerating symptoms.
Numeric Pain Rating Scale
Time frame: 6th week
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pai
Goniometry
Time frame: 6th week
A goniometer is an instrument which measures the available range of motion at a joint. A large Universal Goniometer having 12-inch arms and full-circle plastic body will be used for measuring Assisted Range of Motion (AROM) for hamstring length, it is a useful measurement tool that can be used to do the Active knee extension test. An active knee-extension test has been shown to be a reliable method of assessing hamstring tightness and has good intra-tester reliability [intraclass correlation coefficient (ICC): 0.97-0.98]
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 21 Sep 2020.
- Background: PubMed 30050749Cuenca-Martinez F, Cortes-Amador S, Espi-Lopez GV. Effectiveness of classic physical therapy proposals for chronic non-specific low back pain: a literature review. Phys Ther Res. 2018 Mar 20;21(1):16-22. doi: 10.1298/ptr.E9937. eCollection 2018.
- Backgroundda Silva DA, de Carvalho MEIM, de Andrade Mesquita LS. Effects of a protocol with manual therapy and postural techniques for non-specific low back pain. Manual Therapy, Posturology & Rehabilitation Journal. 2019;17:0-.
- Background: PubMed 19103627Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
- Background: PubMed 29792997Parreira P, Maher CG, Steffens D, Hancock MJ, Ferreira ML. Risk factors for low back pain and sciatica: an umbrella review. Spine J. 2018 Sep;18(9):1715-1721. doi: 10.1016/j.spinee.2018.05.018. Epub 2018 May 21.
- Background: PubMed 30782429Bento TPF, Genebra CVDS, Maciel NM, Cornelio GP, Simeao SFAP, Vitta A. Low back pain and some associated factors: is there any difference between genders? Braz J Phys Ther. 2020 Jan-Feb;24(1):79-87. doi: 10.1016/j.bjpt.2019.01.012. Epub 2019 Feb 13.
- BackgroundAbu-Naser SS, ALDAHDOOH R. Lower back pain expert system diagnosis and treatment. 2016.
- Background: PubMed 17350545Krismer M, van Tulder M; Low Back Pain Group of the Bone and Joint Health Strategies for Europe Project. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007 Feb;21(1):77-91. doi: 10.1016/j.berh.2006.08.004.
- BackgroundAbdullah IB, Al-Mutairi MM, Alghubayan MA, Alamir AA, Bu-Jubarah AY, Almajed N, et al. Literature Review on Prevalence, Risk Factors and, Evaluation of Acute Lower Back Pain. International Journal of Pharmaceutical Research & Allied Sciences. 2020;9(1).
- Background: PubMed 16906196Manchikanti L. Epidemiology of low back pain. Pain Physician. 2000 Apr;3(2):167-92.
- BackgroundBrighton SW. The management of acute low back pain in adults: a guide for the primary care physician, Part II. South African Family Practice. 2013;55(1):26-32.
- Background: PubMed 30588084Paolucci T, Attanasi C, Cecchini W, Marazzi A, Capobianco SV, Santilli V. Chronic low back pain and postural rehabilitation exercise: a literature review. J Pain Res. 2018 Dec 20;12:95-107. doi: 10.2147/JPR.S171729. eCollection 2019.
- Background: PubMed 10796344van Tulder MW, Malmivaara A, Esmail R, Koes BW. Exercise therapy for low back pain. Cochrane Database Syst Rev. 2000;(2):CD000335. doi: 10.1002/14651858.CD000335.
- 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.
Nazish Rafique, MSPT 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 Reeducation Program and Hamstring Stretch Program in people with Back Pain, 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 7 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 21 Sep 2020. 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?
Oswestry Disability Index (ODI) (time frame: 6th week). 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 NCT04555668, which also lists 15 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 21 Sep 2020; AzTrials last refreshed its copy on 28 Oct 2026.