Chronic Low-back PainNCT06240949
Comparison of Positional Release and Manual Pressure Technique in Chronic Low Back Pain
A study testing Positional Release Technique and Manual Pressure Technique in people with Chronic Low-back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effect of positional release technique and manual pressure technique of hip flexors on pain, range of motion, lumbosacral angle and disability in patients with chronic low back pain Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Positional Release Technique and Manual Pressure Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2023to 5 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
- No healthy volunteers
- Adult
Who may be able to join
- Males and females
- age group 25 to 40yrs
- Atraumatic chronic low back pain more than 3 months
- Patients with Anterior pelvic tilt
- Patients with lumbosacral angle > than 50 degrees
Who cannot join
- Pregnancy
- history of vertebral fracture
- History of any spinal surgery
- Disc disease
- Osteoporosis
- Bone disease
- Patient unable to give consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
DHQ and tertiary hospitals
Khanewal
Faiza Altaf
About this study
Official title: Comparative Effects of Positional Release and Manual Pressure Techniques of Tight Hip Flexors on Pain, Range of Motion, Lumbosacral Angle, and Disability in Patients With Chronic Low Back Pain
The purpose of the study is to compare the effect of positional release technique and manual pressure technique of hip flexors on pain, range of motion, lumbosacral angle and disability in patients with chronic low back pain
Read the detailed description
This will be Randomized clinical trial. Individuals who met inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups. Pre intervention assessment is made for both groups. Then intervention will apply to both groups. Group A will receive positional release technique and Group B will be treated by manual pressure technique and pain, range of motion, lumbosacral angle and functional disability will be measured before and after the treatment using NPRS, Inclinometer and ODI. Estimated time of treatment protocol will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting. Subjects will be evaluated at baseline and 4th week assessment will be the final.
- Conditions
- Chronic Low-back Pain
- Being tested
- Positional Release Technique, Manual Pressure Technique
- Keywords
- Low back pain, Chronic low back pain, Hip flexors, positional release technique, Manual Pressure Technique
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional Release TechniqueDevice
Positional Release Technique will be applied on iliopsoas muscle. Treatment time will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting.
Manual Pressure TechniqueDevice
Manual Pressure Technique will be applied on iliopsoas muscle. Treatment time will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Positional release technique | Experimental | Positional release technique will be applied on iliopsoas muscle. Receives: Device: Positional Release Technique |
| Manual pressure technique | Experimental | Manual pressure technique will be applied on iliopsoas muscle. Receives: Device: Manual Pressure Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip flexors tightness
Hip flexors tightness will be assessed using an inclinometer to measure the range of motion (ROM) for active hip extension and Lumbosacral angle
Measured: 4th week
Pain Intensity
Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS)
Measured: 4th week
Functional disability
Functional disability will be assessed by Oswestry disability questionnaire.
Measured: 4th week
Anterior pelvic tilt
Anterior pelvic tilt will be measured using an inclinometer
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Nov 2023
- Primary completion5 Feb 2024 (estimated)
- Study completion5 Feb 2024 (estimated)
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 Chronic Low-back PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, phD, Principal investigator, Riphah International University, LahoreFaiza Alzaf, Principal investigator, Riphah International University, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240949
- Sponsor's protocol ID
- REC/RCR & AHs/23/0168
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juker D, McGill S, Kropf P, Steffen T. Quantitative intramuscular myoelectric activity of lumbar portions of psoas and the abdominal wall during a wide variety of tasks. Med Sci Sports Exerc. 1998 Feb;30(2):301-10. doi: 10.1097/00005768-199802000-00020.
PubMed 9502361Avrahami D, Potvin JR. The clinical and biomechanical effects of fascial-muscular lengthening therapy on tight hip flexor patients with and without low back pain. J Can Chiropr Assoc. 2014 Dec;58(4):444-55.
PubMed 25550670Aslan H, Buddhadev HH, Suprak DN, San Juan JG. ACUTE EFFECTS OF TWO HIP FLEXOR STRETCHING TECHNIQUES ON KNEE JOINT POSITION SENSE AND BALANCE. Int J Sports Phys Ther. 2018 Aug;13(5):846-859.
PubMed 30276017Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
PubMed 21665125Naik Prashant P, Anand H, Khatri Subhash M. Comparison of muscle energy technique and positional release therapy in acute low back pain-RCT. Physiotherapy and Occupational Therapy. 2010;32
Deyo RA, Von Korff M, Duhrkoop D. Opioids for low back pain. BMJ. 2015 Jan 5;350:g6380. doi: 10.1136/bmj.g6380.
PubMed 25561513Gonzalez-Galvez N, Gea-Garcia GM, Marcos-Pardo PJ. Effects of exercise programs on kyphosis and lordosis angle: A systematic review and meta-analysis. PLoS One. 2019 Apr 29;14(4):e0216180. doi: 10.1371/journal.pone.0216180. eCollection 2019.
PubMed 31034509Santaguida PL, McGill SM. The psoas major muscle: a three-dimensional geometric study. J Biomech. 1995 Mar;28(3):339-45. doi: 10.1016/0021-9290(94)00064-b.
PubMed 7730392Licciardone JC, Kearns CM, Crow WT. Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Aug;19(4):324-30. doi: 10.1016/j.math.2014.03.004. Epub 2014 Mar 18.
PubMed 24704126Chaitow L. Positional Release Techniques E-Book: Elsevier health sciences; 2007
Ibraheem EEMAE. Conventional therapy versus positional release technique in the treatment of chronic low back dysfunction. Int J Physiother Res. 2017;5(5):2325-31
Hanson P, Magnusson SP, Simonsen EB. Differences in sacral angulation and lumbosacral curvature in black and white young men and women. Acta Anat (Basel). 1998;162(4):226-31. doi: 10.1159/000046437.
PubMed 9831771Mosner EA, Bryan JM, Stull MA, Shippee R. A comparison of actual and apparent lumbar lordosis in black and white adult females. Spine (Phila Pa 1976). 1989 Mar;14(3):310-4. doi: 10.1097/00007632-198903000-00011.
PubMed 2711246Naik MS, Shah DN. Prevalence of tightness in hip joint muscles in middle aged women engaging in prolonged desk job: Descriptive study. Age. 2022;43:6.077908
AWATEF ML, ALI FAM, SHIMAA T, MAGDA GS. Effect of lumbar hyperlordosis correction on craniovertebral angle in low back pain patients. The Medical Journal of Cairo University. 2020;88(December):2051-7.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Positional Release and Manual Pressure Techniques of Tight Hip Flexors on Pain, Range of Motion, Lumbosacral Angle, and Disability in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06240949
- Acronym / sponsor ID
- REC/RCR & AHs/23/0168
- Conditions
- Chronic Low-back Pain
- Keywords
- Low back pain, Chronic low back pain, Hip flexors, positional release technique, Manual Pressure Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 5 Feb 2024 (estimated)
- Study completion
- 5 Feb 2024 (estimated)
- First posted
- 5 Feb 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.
The purpose of the study is to compare the effect of positional release technique and manual pressure technique of hip flexors on pain, range of motion, lumbosacral angle and disability in patients with chronic low back pain
Detailed description
This will be Randomized clinical trial. Individuals who met inclusion criteria will be included in this study. All participants will go through randomization and divided into two groups. Pre intervention assessment is made for both groups. Then intervention will apply to both groups. Group A will receive positional release technique and Group B will be treated by manual pressure technique and pain, range of motion, lumbosacral angle and functional disability will be measured before and after the treatment using NPRS, Inclinometer and ODI. Estimated time of treatment protocol will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting. Subjects will be evaluated at baseline and 4th week assessment will be the final.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positional release technique | Experimental | Device: Positional Release TechniquePositional release technique will be applied on iliopsoas muscle. |
| Manual pressure technique | Experimental | Device: Manual Pressure TechniqueManual pressure technique will be applied on iliopsoas muscle. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females
- age group 25 to 40yrs
- Atraumatic chronic low back pain more than 3 months
- Patients with Anterior pelvic tilt
- Patients with lumbosacral angle > than 50 degrees
Key exclusion criteria (7 listed)
- Pregnancy
- history of vertebral fracture
- History of any spinal surgery
- Disc disease
- Osteoporosis
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 |
|---|---|---|
| Positional Release TechniquePositional Release Technique will be applied on iliopsoas muscle. Treatment time will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting. | Device | Positional release technique |
| Manual Pressure TechniqueManual Pressure Technique will be applied on iliopsoas muscle. Treatment time will be 30 minutes per session, 4 times/week for 4 weeks in the hospital setting. | Device | Manual pressure technique |
Primary outcome
Hip flexors tightness
Time frame: 4th week
Hip flexors tightness will be assessed using an inclinometer to measure the range of motion (ROM) for active hip extension and Lumbosacral angle
Pain Intensity
Time frame: 4th week
Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS)
Functional disability
Time frame: 4th week
Functional disability will be assessed by Oswestry disability questionnaire.
Anterior pelvic tilt
Time frame: 4th week
Anterior pelvic tilt will be measured using an inclinometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 9502361Juker D, McGill S, Kropf P, Steffen T. Quantitative intramuscular myoelectric activity of lumbar portions of psoas and the abdominal wall during a wide variety of tasks. Med Sci Sports Exerc. 1998 Feb;30(2):301-10. doi: 10.1097/00005768-199802000-00020.
- Background: PubMed 25550670Avrahami D, Potvin JR. The clinical and biomechanical effects of fascial-muscular lengthening therapy on tight hip flexor patients with and without low back pain. J Can Chiropr Assoc. 2014 Dec;58(4):444-55.
- Background: PubMed 30276017Aslan H, Buddhadev HH, Suprak DN, San Juan JG. ACUTE EFFECTS OF TWO HIP FLEXOR STRETCHING TECHNIQUES ON KNEE JOINT POSITION SENSE AND BALANCE. Int J Sports Phys Ther. 2018 Aug;13(5):846-859.
- Background: PubMed 21665125Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
- BackgroundNaik Prashant P, Anand H, Khatri Subhash M. Comparison of muscle energy technique and positional release therapy in acute low back pain-RCT. Physiotherapy and Occupational Therapy. 2010;32
- Background: PubMed 25561513Deyo RA, Von Korff M, Duhrkoop D. Opioids for low back pain. BMJ. 2015 Jan 5;350:g6380. doi: 10.1136/bmj.g6380.
- Background: PubMed 31034509Gonzalez-Galvez N, Gea-Garcia GM, Marcos-Pardo PJ. Effects of exercise programs on kyphosis and lordosis angle: A systematic review and meta-analysis. PLoS One. 2019 Apr 29;14(4):e0216180. doi: 10.1371/journal.pone.0216180. eCollection 2019.
- Background: PubMed 7730392Santaguida PL, McGill SM. The psoas major muscle: a three-dimensional geometric study. J Biomech. 1995 Mar;28(3):339-45. doi: 10.1016/0021-9290(94)00064-b.
- Background: PubMed 24704126Licciardone JC, Kearns CM, Crow WT. Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Aug;19(4):324-30. doi: 10.1016/j.math.2014.03.004. Epub 2014 Mar 18.
- BackgroundChaitow L. Positional Release Techniques E-Book: Elsevier health sciences; 2007
- BackgroundIbraheem EEMAE. Conventional therapy versus positional release technique in the treatment of chronic low back dysfunction. Int J Physiother Res. 2017;5(5):2325-31
- Background: PubMed 9831771Hanson P, Magnusson SP, Simonsen EB. Differences in sacral angulation and lumbosacral curvature in black and white young men and women. Acta Anat (Basel). 1998;162(4):226-31. doi: 10.1159/000046437.
- 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.
Saba Rafique, phD principal investigator
Riphah International University, Lahore
Faiza Alzaf principal investigator
Riphah International University, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positional Release Technique and Manual Pressure Technique in people with Chronic Low-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 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 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 Imran Amjad, phD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip flexors tightness (time frame: 4th week). The study lists 4 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 NCT06240949, 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 5 Feb 2024.