Chronic Low-back PainNCT06110026
Bronkow Program and Lumbar Stabilization Exercises in Chronic Non Specific Low Back Pain
A study testing Brunkow Exercise Program and Lumbar Stabilization Exercises in people with Chronic Low-back Pain and Non Specific Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the effects of brunkow exercise program and lumbar stabilization exercises on pain, range of motion and disability in patients with chronic non- specific low back pain Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Chronic Low-back Pain, Non Specific Low Back Pain
- What is being tested?
- Brunkow Exercise Program and Lumbar Stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 8 May 2023to 8 Jan 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 45 years
- Both male and female
- Low back pain > 6 months
- NPRS>3
- The symptoms of pain are lessened or disappeared after bed rest, while pain symptoms are aggravated after bending over, sitting for a long time, or standing for a long time.
Who cannot join
- Pelvic bone fracture
- Pregnancy
- Pelvic implants
- Lumbosacral disc herniation
- Sacroiliac joint inflammation
- Lumbar spine fracture
Show all 9Show fewer
- Inflammatory bowel disease
- Malignancy
- Ankylosing spondylitis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
Humera Mubashar, MSPT, 03084157979, humeramubashar2@riphah.edu.pk
Kiran Liaquat, MS-OMPT
About this study
Official title: Comparative Effects of Brunkow Program and Lumbar Stabilization Exercises on Pain, Range of Motion and Disability in Chronic Nonspecific Low Back Pain
The aim of this study is to compare the effects of brunkow exercise program and lumbar stabilization exercises on pain, range of motion and disability in patients with chronic non- specific low back pain
Read the detailed description
The majority of research studies have primarily focused on lumbar stabilization exercises used as a standard treatment with mobilization. To the best of our knowledge it has shown that lumbar stabilization exercises alone are less efficient than lumbar stabilization exercises in strengthening muscular strength and decreasing pain in female patients with persistent low back pain than lumbar stabilization exercises combined with pain neuroscience education. However, more extensive research on a range of educational and activity programs was required. Stabilization exercises with other modalities, manual techniques, mobilizations, or exercise therapy have been practiced in the treatment of chronic non specific low back pain were found effective individually, but there was a lack of comprehensive studies including randomized clinical trials directly comparing the brunkow exercises program with stabilization exercises in patients with chronic non- specific low back pain.
This study investigates and adds up an effective and evolutionary treatment protocol in the world of physical therapy for the management of chronic non-specific low back pain rather than other conventional therapy providing to the patients with chronic low back pain now a days.
- Conditions
- Chronic Low-back Pain, Non Specific Low Back Pain
- Being tested
- Brunkow Exercise Program, Lumbar Stabilization Exercises
- Keywords
- Brunkow exercise, Disability, non-specific low back pain, pain, range of motion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brunkow Exercise ProgramOther
The brunkow exercise program will be comprised of four exercise programs. Each exercise will be performed with two sets of 15 reps, 10 sec per rep 40 min per day, thrice per week for a total of four weeks.
Lumbar Stabilization ExercisesOther
The lumbar stabilization exercises will be comprised of four exercise programs. Each exercise will be performed with two sets of 15 reps, 10 sec per rep 40 min per day, thrice per week for a total of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Brunkow exercise program | Experimental | Brunkow program includes Push up and stabilization against the wrists and heels,brunkow- from plank to a standing position ,plank from lying on the stomach to a sitting in a tilted position, Turning from the back to the position on all four Receives: Other: Brunkow Exercise Program |
| Lumbar stabilization exercises | Experimental | lumbar stabilization exercises protocol includes Diaphragmatic breathing and abdominal bracing, bridging, side plank on knees, bird dog Receives: Other: Lumbar Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS-11)
It is is an eleven-point scale in which the end points are the extremes of no pain at all (score of 0) and the worst pain the patient has ever experienced (score of 10). NRS-11 pain severity score of "4" is frequently given special significance in this regard, suggesting it as a potential threshold value for pain severity in clinical practice. (28).
This scale has high reliability (0.95-0.96) and validity (0.86-0.96).
Measured: 4 weeks
Modified oswestry disability index
The ODI is a disease-specific disability measure is used to establish a level of disability, stage a patient's acuity status and monitor change over time. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum). This tool is considered as a gold standard for back pain functional. Test-retest reliability has been shown to be high. Values range from r= 0.83 to 0.99 and vary according to the time interval between measurements. ODI = (Sum of items scored/Sum of sections answered) X 100
Measured: 4 weeks
Inclinometer
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry.1 Inclinometers are typically found in clinics and are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87- 0.95. Range of motion is the measurement of movement around a specific joint or body part.
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 posted31 Oct 2023
- Study start8 May 2023
- Primary completion23 Dec 2023 (estimated)
- Study completion8 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-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, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110026
- Sponsor's protocol ID
- REC/RCR&AHS/23/0146
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orrock PJ, Myers SP. Osteopathic intervention in chronic non-specific low back pain: a systematic review. BMC Musculoskelet Disord. 2013 Apr 9;14:129. doi: 10.1186/1471-2474-14-129.
PubMed 23570655Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
PubMed 19502217Garcia JB, Hernandez-Castro JJ, Nunez RG, Pazos MA, Aguirre JO, Jreige A, Delgado W, Serpentegui M, Berenguel M, Cantemir C. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014 Sep-Oct;17(5):379-91.
PubMed 25247896Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.
PubMed 26000680Forster M, Mahn F, Gockel U, Brosz M, Freynhagen R, Tolle TR, Baron R. Axial low back pain: one painful area--many perceptions and mechanisms. PLoS One. 2013 Jul 2;8(7):e68273. doi: 10.1371/journal.pone.0068273. Print 2013.
PubMed 23844179Violante FS, Mattioli S, Bonfiglioli R. Low-back pain. Handb Clin Neurol. 2015;131:397-410. doi: 10.1016/B978-0-444-62627-1.00020-2.
PubMed 26563799Waseem M, Karimi H, Gilani SA, Hassan D. Treatment of disability associated with chronic non-specific low back pain using core stabilization exercises in Pakistani population. J Back Musculoskelet Rehabil. 2019;32(1):149-154. doi: 10.3233/BMR-171114.
PubMed 30248035Faas A. Exercises: which ones are worth trying, for which patients, and when? Spine (Phila Pa 1976). 1996 Dec 15;21(24):2874-8; discussion 2878-9. doi: 10.1097/00007632-199612150-00016.
PubMed 9112711Mujic Skikic E, Trebinjac S, Sakota S, Avdic D. The effects of McKenzie and Brunkow exercise program on spinal mobility comparative study. Bosn J Basic Med Sci. 2004 Feb;4(1):62-8. doi: 10.17305/bjbms.2004.3466.
PubMed 15628984Yeom S, Jeong H, Lee H, Jeon K. Effects of Lumbar Stabilization Exercises on Isokinetic Strength and Muscle Tension in Sedentary Men. Bioengineering (Basel). 2023 Mar 8;10(3):342. doi: 10.3390/bioengineering10030342.
PubMed 36978733Skikic EM, Trebinjac S, Sakota S, Avdic D, Delic A. Brunkow exercises and low back pain. Bosn J Basic Med Sci. 2004 Oct;4(4):37-41. doi: 10.17305/bjbms.2004.3359.
PubMed 15628994Lee HS, Kim DJ, Oh Y, Min K, Ryu JS. The effect of individualized gradable stabilization exercises in patients with chronic low back pain: Case-control study. J Back Musculoskelet Rehabil. 2016 Jun 17;29(3):603-10. doi: 10.3233/BMR-160724.
PubMed 27341643Kim CR, Park DK, Lee ST, Ryu JS. Electromyographic Changes in Trunk Muscles During Graded Lumbar Stabilization Exercises. PM R. 2016 Oct;8(10):979-989. doi: 10.1016/j.pmrj.2016.05.017. Epub 2016 Jun 16.
PubMed 27317910Lee K. Motion Analysis of Core Stabilization Exercise in Women: Kinematics and Electromyographic Analysis. Sports (Basel). 2023 Mar 10;11(3):66. doi: 10.3390/sports11030066.
PubMed 36976952Kim KS, An J, Kim JO, Lee MY, Lee BH. Effects of Pain Neuroscience Education Combined with Lumbar Stabilization Exercise on Strength and Pain in Patients with Chronic Low Back Pain: Randomized Controlled Trial. J Pers Med. 2022 Feb 17;12(2):303. doi: 10.3390/jpm12020303.
PubMed 35207790
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Brunkow Program and Lumbar Stabilization Exercises on Pain, Range of Motion and Disability in Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT06110026
- Acronym / sponsor ID
- REC/RCR&AHS/23/0146
- Conditions
- Chronic Low-back Pain, Non Specific Low Back Pain
- Keywords
- Brunkow exercise, Disability, non-specific low back pain, pain, range of motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 8 Jan 2024 (estimated)
- First posted
- 31 Oct 2023 (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 aim of this study is to compare the effects of brunkow exercise program and lumbar stabilization exercises on pain, range of motion and disability in patients with chronic non- specific low back pain
Detailed description
The majority of research studies have primarily focused on lumbar stabilization exercises used as a standard treatment with mobilization. To the best of our knowledge it has shown that lumbar stabilization exercises alone are less efficient than lumbar stabilization exercises in strengthening muscular strength and decreasing pain in female patients with persistent low back pain than lumbar stabilization exercises combined with pain neuroscience education. However, more extensive research on a range of educational and activity programs was required. Stabilization exercises with other modalities, manual techniques, mobilizations, or exercise therapy have been practiced in the treatment of chronic non specific low back pain were found effective individually, but there was a lack of comprehensive studies including randomized clinical trials directly comparing the brunkow exercises program with stabilization exercises in patients with chronic non- specific low back pain.
This study investigates and adds up an effective and evolutionary treatment protocol in the world of physical therapy for the management of chronic non-specific low back pain rather than other conventional therapy providing to the patients with chronic low back pain now a days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brunkow exercise program | Experimental | Other: Brunkow Exercise ProgramBrunkow program includes Push up and stabilization against the wrists and heels,brunkow- from plank to a standing position ,plank from lying on the stomach to a sitting in a tilted position, Turning from the back to the position on all four |
| Lumbar stabilization exercises | Experimental | Other: Lumbar Stabilization Exerciseslumbar stabilization exercises protocol includes Diaphragmatic breathing and abdominal bracing, bridging, side plank on knees, bird dog |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20 to 45 years
- Both male and female
- Low back pain > 6 months
- NPRS>3
- The symptoms of pain are lessened or disappeared after bed rest, while pain symptoms are aggravated after bending over, sitting for a long time, or standing for a long time.
Key exclusion criteria (9 listed)
- Pelvic bone fracture
- Pregnancy
- Pelvic implants
- Lumbosacral disc herniation
- Sacroiliac joint inflammation
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 |
|---|---|---|
| Brunkow Exercise ProgramThe brunkow exercise program will be comprised of four exercise programs. Each exercise will be performed with two sets of 15 reps, 10 sec per rep 40 min per day, thrice per week for a total of four weeks. | Other | Brunkow exercise program |
| Lumbar Stabilization ExercisesThe lumbar stabilization exercises will be comprised of four exercise programs. Each exercise will be performed with two sets of 15 reps, 10 sec per rep 40 min per day, thrice per week for a total of four weeks. | Other | Lumbar stabilization exercises |
Primary outcome
Numeric rating scale (NRS-11)
Time frame: 4 weeks
It is is an eleven-point scale in which the end points are the extremes of no pain at all (score of 0) and the worst pain the patient has ever experienced (score of 10). NRS-11 pain severity score of "4" is frequently given special significance in this regard, suggesting it as a potential threshold value for pain severity in clinical practice. (28). This scale has high reliability (0.95-0.96) and validity (0.86-0.96).
Modified oswestry disability index
Time frame: 4 weeks
The ODI is a disease-specific disability measure is used to establish a level of disability, stage a patient's acuity status and monitor change over time. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum). This tool is considered as a gold standard for back pain functional. Test-retest reliability has been shown to be high. Values range from r= 0.83 to 0.99 and vary according to the time interval between measurements. ODI = (Sum of items scored/Sum of sections answered) X 100
Inclinometer
Time frame: 4 weeks
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry.1 Inclinometers are typically found in clinics and are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87- 0.95. Range of motion is the measurement of movement around a specific joint or body part.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 23570655Orrock PJ, Myers SP. Osteopathic intervention in chronic non-specific low back pain: a systematic review. BMC Musculoskelet Disord. 2013 Apr 9;14:129. doi: 10.1186/1471-2474-14-129.
- Background: PubMed 19502217Savigny P, Watson P, Underwood M; Guideline Development Group. Early management of persistent non-specific low back pain: summary of NICE guidance. BMJ. 2009 Jun 4;338:b1805. doi: 10.1136/bmj.b1805. No abstract available.
- Background: PubMed 25247896Garcia JB, Hernandez-Castro JJ, Nunez RG, Pazos MA, Aguirre JO, Jreige A, Delgado W, Serpentegui M, Berenguel M, Cantemir C. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014 Sep-Oct;17(5):379-91.
- Background: PubMed 26000680Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.
- Background: PubMed 23844179Forster M, Mahn F, Gockel U, Brosz M, Freynhagen R, Tolle TR, Baron R. Axial low back pain: one painful area--many perceptions and mechanisms. PLoS One. 2013 Jul 2;8(7):e68273. doi: 10.1371/journal.pone.0068273. Print 2013.
- Background: PubMed 26563799Violante FS, Mattioli S, Bonfiglioli R. Low-back pain. Handb Clin Neurol. 2015;131:397-410. doi: 10.1016/B978-0-444-62627-1.00020-2.
- Background: PubMed 30248035Waseem M, Karimi H, Gilani SA, Hassan D. Treatment of disability associated with chronic non-specific low back pain using core stabilization exercises in Pakistani population. J Back Musculoskelet Rehabil. 2019;32(1):149-154. doi: 10.3233/BMR-171114.
- Background: PubMed 9112711Faas A. Exercises: which ones are worth trying, for which patients, and when? Spine (Phila Pa 1976). 1996 Dec 15;21(24):2874-8; discussion 2878-9. doi: 10.1097/00007632-199612150-00016.
- Background: PubMed 15628984Mujic Skikic E, Trebinjac S, Sakota S, Avdic D. The effects of McKenzie and Brunkow exercise program on spinal mobility comparative study. Bosn J Basic Med Sci. 2004 Feb;4(1):62-8. doi: 10.17305/bjbms.2004.3466.
- Background: PubMed 36978733Yeom S, Jeong H, Lee H, Jeon K. Effects of Lumbar Stabilization Exercises on Isokinetic Strength and Muscle Tension in Sedentary Men. Bioengineering (Basel). 2023 Mar 8;10(3):342. doi: 10.3390/bioengineering10030342.
- Background: PubMed 15628994Skikic EM, Trebinjac S, Sakota S, Avdic D, Delic A. Brunkow exercises and low back pain. Bosn J Basic Med Sci. 2004 Oct;4(4):37-41. doi: 10.17305/bjbms.2004.3359.
- Background: PubMed 27341643Lee HS, Kim DJ, Oh Y, Min K, Ryu JS. The effect of individualized gradable stabilization exercises in patients with chronic low back pain: Case-control study. J Back Musculoskelet Rehabil. 2016 Jun 17;29(3):603-10. doi: 10.3233/BMR-160724.
- 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.
Humera Mubashar, 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 Brunkow Exercise Program and Lumbar Stabilization Exercises in people with Chronic Low-back Pain and Non Specific 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 9 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 31 Oct 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?
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?
Numeric rating scale (NRS-11) (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 NCT06110026, which also lists 30 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 31 Oct 2023.