Low Back PainNCT06049277
Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain
A study testing Mulligan techniques with manual traction and McKenzie extension exercises with manual traction in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project will be a Randomized clinical trial conducted to determine effects of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mulligan techniques with manual traction and McKenzie extension exercises with manual traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2023to 15 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 28-50 years
- Patients of both gender
- Clinically diagnosed patient with Lumbar radiculopathy
Who cannot join
- Subject with chronic radicular low back pain with the history of spinal surgery
- Patients who have recently received corticosteroids
- Diagnosed cases of osteoporosis
- History of recent Fracture
- Lumber instability
- Trauma
- Inflammatory disorders
- Acute disc bulge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mulligan Technique Versus McKenzie Extension Exercise With Manual Traction in Patients With Chronic Unilateral Radicular Low Back Pain
This project will be a Randomized clinical trial conducted to determine effects of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain. Sample will be collected through non-probability convenient sampling, following eligibility criteria from Rehab Care and Jinnah Hospital Lahore. Eligibility criteria will be both gender and age range 28-50 years, clinically diagnosed patient with Lumbar radiculopathy after exclusion of the patients with Fracture, Trauma, Inflammatory disorder, acute disc bulge, Lumbar instability. Participants will be randomly allocated in two groups via sealed envelope method, baseline assessment will be done, Group A participants will be given baseline treatment along with Mulligan techniques, Group B participants will be given baseline treatment along with McKenzie protocol. Pre and post intervention assessment will be done via, Numeric pain rating scale(NPRS), Oswestry Disability Scale (ODI) and lumber Range of Motion, 2 sessions per week will be given for 4 weeks, data will be analyzed by using SPSS version 29.
Read the detailed description
Chronic mechanical low back pain is common among different age groups and genders. Different manual therapy techniques combined with exercise therapy and electrotherapy modalities play an important role in its management. Our objective was to compare the effects of McKenzie extension exercises program versus Mulligan Techniques for chronic unilateral radicular low back pain. The primary objective of my study is to evaluate the outcome of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain in terms of pain reduction and ROM.
A randomized control trial will be conducted at Rehab Care and Jinnah Hospital Lahore, from 1st June - 31st January 2024. Both genders and age range 28-50 years clinically diagnosed patient with Lumbar radiculopathy will be included. The patients with Fracture, Trauma, Inflammatory disorder, acute disc bulge, Lumbar instability will be excluded. Subjects will be divided into two equal groups through a computer-generated random number. Sixteen patients in group A will be treated with Mulligan techniques and Sixteen patients in group B with McKenzie for four weeks at two session per week and single session per day. Visual Analogue Scale, Oswestry Disability Scale and lumbar Range of Motion will be used as an assessment tool and were measured at baseline and at the completion 4 weeks intervention. The data will be entered and analyzed with SPSS to draw the statistical and clinical significance of both interventions. Results will be presented as mean and standard deviation for numerical variables like Visual Analogue Scale, Oswestry Disability Scale and lumber Range of Motion. Analysis will be done by statistical package for social sciences SPSS 29
- Conditions
- Low Back Pain
- Being tested
- Mulligan techniques with manual traction, McKenzie extension exercises with manual traction
- Keywords
- Low Back Pain, Range of Motion, Manual Therapy, Pain, Mobilization
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan techniques with manual tractionOther
group A will be treated with Mulligan techniques with manual traction.16 patients in group A will be treated with Mulligan Techniques SNAGS in sitting, standing and prone position by applying Antero cranial glide in the direction of treatment plane over the spinous or transverse process and Spinal mobilization with leg movement at 6 to 8 repetitions per sessions and spinal mobilization with leg movement will be performed in side lying, patient facing the physiotherapist while the leg movement may assisted by another person (Physiotherapist/assistant). Sustained transverse glide is given on the desired spinous process with 10 repetitions of offending movement in first session while 10 reps in each of 3 sets in further sessions.
McKenzie extension exercises with manual tractionOther
group B will be treated McKenzie extension exercises with manual traction.16 patients in group B will be treated with McKenzie active EEP in prone position with repeated movements along with standard protocols. McKenzie Extension Exercises performed actively in prone position. Extension exercises performed in three stages, initially patient instructed to be just lift the neck and look on front at the eye level, then progressed next and weight bearing on the elbow by lifting up the shoulder and then moved on third and final steps in which complete trunk extension is performed and weight bearing is on the hands.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan techniques with manual traction | Experimental | Mulligan techniques with manual traction Receives: Other: Mulligan techniques with manual traction |
| McKenzie extension exercises with manual traction | Active comparator | McKenzie extension exercises with manual traction Receives: Other: McKenzie extension exercises with manual traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Measured: 4th Week
Oswestry Disability Scale (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.
Measured: 4th Week
Range of Motion
Assessment of range of motion (ROM) of the lumbar spine is an important part lumbar spine examination. Range of motion will be measured with inclinometer. Aberrant spinal motion is associated with faulty spinal mechanics. Motion of the lumbar spine will be assessed in all planes including flexion, extension, side bending, and rotation. Variables affect lumbar range of motion
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 posted22 Sep 2023
- Study start25 Sep 2023
- Primary completion10 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, Principal investigator, Riphah International University, Lahore, PakistanMaira Saeed, Principal investigator, Riphah International University, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049277
- Sponsor's protocol ID
- REC/RCR&AHS/23/0133 Maira
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buran Cirak Y, Yurdaisik I, Elbasi ND, Tutuneken YE, Koce K, Cinar B. Effect of Sustained Natural Apophyseal Glides on Stiffness of Lumbar Stabilizer Muscles in Patients With Nonspecific Low Back Pain: Randomized Controlled Trial. J Manipulative Physiol Ther. 2021 Jul-Aug;44(6):445-454. doi: 10.1016/j.jmpt.2021.06.005. Epub 2021 Aug 26.
PubMed 34456042Tul Ain SQ, Shakil Ur Rehman S, Maryam M, Kiani SK. Effects of Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques on mechanical back pain: a randomized control trial. J Pak Med Assoc. 2019 Nov;69(11):1584-1587. doi: 10.5455/JPMA.274875..
PubMed 31740859Waqqar S, Shakil-Ur-Rehman S, Ahmad S. McKenzie treatment versus mulligan sustained natural apophyseal glides for chronic mechanical low back pain. Pak J Med Sci. 2016 Mar-Apr;32(2):476-9. doi: 10.12669/pjms.322.9127.
PubMed 27182265Cuesta-Vargas A, Farasyn A, Gabel CP, Luciano JV. The mechanical and inflammatory low back pain (MIL) index: development and validation. BMC Musculoskelet Disord. 2014 Jan 9;15:12. doi: 10.1186/1471-2474-15-12.
PubMed 24405779O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
PubMed 9431633Chitale N Jr, Patil DS, Phansopkar P, Joshi A. A Review on Treatment Approaches for Chronic Low Back Pain via Mulligans Movement With Mobilization and Physical Therapy. Cureus. 2022 Aug 18;14(8):e28127. doi: 10.7759/cureus.28127. eCollection 2022 Aug.
PubMed 36134056Salik S RS, Hayaat R, Manzoor S, Malik AU, Maqbool S. Comparison of Mulligan sustained natural apophyseal glides verses Mckenzie extension exercises on disability and functional outcomes in patients with acute nonspecific low back pain. PJMHS. 2022;16(10):1:5.
May S, Donelson R. Evidence-informed management of chronic low back pain with the McKenzie method. Spine J. 2008 Jan-Feb;8(1):134-41. doi: 10.1016/j.spinee.2007.10.017.
PubMed 18164461Almeida MO, Narciso Garcia A, Menezes Costa LC, van Tulder MW, Lin CC, Machado LA. The McKenzie method for (sub)acute non-specific low back pain. Cochrane Database Syst Rev. 2023 Apr 5;4(4):CD009711. doi: 10.1002/14651858.CD009711.pub2.
PubMed 37017272
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan Technique Versus McKenzie Extension Exercise With Manual Traction in Patients With Chronic Unilateral Radicular Low Back Pain
- ClinicalTrials.gov ID
- NCT06049277
- Acronym / sponsor ID
- REC/RCR&AHS/23/0133 Maira
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Range of Motion, Manual Therapy, Pain, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Sep 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.
This project will be a Randomized clinical trial conducted to determine effects of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain. Sample will be collected through non-probability convenient sampling, following eligibility criteria from Rehab Care and Jinnah Hospital Lahore. Eligibility criteria will be both gender and age range 28-50 years, clinically diagnosed patient with Lumbar radiculopathy after exclusion of the patients with Fracture, Trauma, Inflammatory disorder, acute disc bulge, Lumbar instability. Participants will be randomly allocated in two groups via sealed envelope method, baseline assessment will be done, Group A participants will be given baseline treatment along with Mulligan techniques, Group B participants will be given baseline treatment along with McKenzie protocol. Pre and post intervention assessment will be done via, Numeric pain rating scale(NPRS), Oswestry Disability Scale (ODI) and lumber Range of Motion, 2 sessions per week will be given for 4 weeks, data will be analyzed by using SPSS version 29.
Detailed description
Chronic mechanical low back pain is common among different age groups and genders. Different manual therapy techniques combined with exercise therapy and electrotherapy modalities play an important role in its management. Our objective was to compare the effects of McKenzie extension exercises program versus Mulligan Techniques for chronic unilateral radicular low back pain. The primary objective of my study is to evaluate the outcome of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain in terms of pain reduction and ROM.
A randomized control trial will be conducted at Rehab Care and Jinnah Hospital Lahore, from 1st June - 31st January 2024. Both genders and age range 28-50 years clinically diagnosed patient with Lumbar radiculopathy will be included. The patients with Fracture, Trauma, Inflammatory disorder, acute disc bulge, Lumbar instability will be excluded. Subjects will be divided into two equal groups through a computer-generated random number. Sixteen patients in group A will be treated with Mulligan techniques and Sixteen patients in group B with McKenzie for four weeks at two session per week and single session per day. Visual Analogue Scale, Oswestry Disability Scale and lumbar Range of Motion will be used as an assessment tool and were measured at baseline and at the completion 4 weeks intervention. The data will be entered and analyzed with SPSS to draw the statistical and clinical significance of both interventions. Results will be presented as mean and standard deviation for numerical variables like Visual Analogue Scale, Oswestry Disability Scale and lumber Range of Motion. Analysis will be done by statistical package for social sciences SPSS 29
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan techniques with manual traction | Experimental | Other: Mulligan techniques with manual tractionMulligan techniques with manual traction |
| McKenzie extension exercises with manual traction | Active comparator | Other: McKenzie extension exercises with manual tractionMcKenzie extension exercises with manual traction |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range 28-50 years
- Patients of both gender
- Clinically diagnosed patient with Lumbar radiculopathy
Key exclusion criteria (8 listed)
- Subject with chronic radicular low back pain with the history of spinal surgery
- Patients who have recently received corticosteroids
- Diagnosed cases of osteoporosis
- History of recent Fracture
- Lumber instability
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 |
|---|---|---|
| Mulligan techniques with manual tractiongroup A will be treated with Mulligan techniques with manual traction.16 patients in group A will be treated with Mulligan Techniques SNAGS in sitting, standing and prone position by applying Antero cranial glide in the direction of treatment plane over the spinous or transverse process and Spinal mobilization with leg movement at 6 to 8 repetitions per sessions and spinal mobilization with leg movement will be performed in side lying, patient facing the physiotherapist while the leg movement may assisted by another person (Physiotherapist/assistant). Sustained transverse glide is given on the desired spinous process with 10 repetitions of offending movement in first session while 10 reps in each of 3 sets in further sessions. | Other | Mulligan techniques with manual traction |
| McKenzie extension exercises with manual tractiongroup B will be treated McKenzie extension exercises with manual traction.16 patients in group B will be treated with McKenzie active EEP in prone position with repeated movements along with standard protocols. McKenzie Extension Exercises performed actively in prone position. Extension exercises performed in three stages, initially patient instructed to be just lift the neck and look on front at the eye level, then progressed next and weight bearing on the elbow by lifting up the shoulder and then moved on third and final steps in which complete trunk extension is performed and weight bearing is on the hands. | Other | McKenzie extension exercises with manual traction |
Primary outcome
NPRS
Time frame: 4th Week
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Oswestry Disability Scale (ODI)
Time frame: 4th 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.
Range of Motion
Time frame: 4th Week
Assessment of range of motion (ROM) of the lumbar spine is an important part lumbar spine examination. Range of motion will be measured with inclinometer. Aberrant spinal motion is associated with faulty spinal mechanics. Motion of the lumbar spine will be assessed in all planes including flexion, extension, side bending, and rotation. Variables affect lumbar range of motion
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 30 Jan 2024.
- Background: PubMed 34456042Buran Cirak Y, Yurdaisik I, Elbasi ND, Tutuneken YE, Koce K, Cinar B. Effect of Sustained Natural Apophyseal Glides on Stiffness of Lumbar Stabilizer Muscles in Patients With Nonspecific Low Back Pain: Randomized Controlled Trial. J Manipulative Physiol Ther. 2021 Jul-Aug;44(6):445-454. doi: 10.1016/j.jmpt.2021.06.005. Epub 2021 Aug 26.
- Background: PubMed 31740859Tul Ain SQ, Shakil Ur Rehman S, Maryam M, Kiani SK. Effects of Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques on mechanical back pain: a randomized control trial. J Pak Med Assoc. 2019 Nov;69(11):1584-1587. doi: 10.5455/JPMA.274875..
- Background: PubMed 27182265Waqqar S, Shakil-Ur-Rehman S, Ahmad S. McKenzie treatment versus mulligan sustained natural apophyseal glides for chronic mechanical low back pain. Pak J Med Sci. 2016 Mar-Apr;32(2):476-9. doi: 10.12669/pjms.322.9127.
- Background: PubMed 24405779Cuesta-Vargas A, Farasyn A, Gabel CP, Luciano JV. The mechanical and inflammatory low back pain (MIL) index: development and validation. BMC Musculoskelet Disord. 2014 Jan 9;15:12. doi: 10.1186/1471-2474-15-12.
- Background: PubMed 9431633O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
- Background: PubMed 36134056Chitale N Jr, Patil DS, Phansopkar P, Joshi A. A Review on Treatment Approaches for Chronic Low Back Pain via Mulligans Movement With Mobilization and Physical Therapy. Cureus. 2022 Aug 18;14(8):e28127. doi: 10.7759/cureus.28127. eCollection 2022 Aug.
- BackgroundSalik S RS, Hayaat R, Manzoor S, Malik AU, Maqbool S. Comparison of Mulligan sustained natural apophyseal glides verses Mckenzie extension exercises on disability and functional outcomes in patients with acute nonspecific low back pain. PJMHS. 2022;16(10):1:5.
- Background: PubMed 18164461May S, Donelson R. Evidence-informed management of chronic low back pain with the McKenzie method. Spine J. 2008 Jan-Feb;8(1):134-41. doi: 10.1016/j.spinee.2007.10.017.
- Background: PubMed 37017272Almeida MO, Narciso Garcia A, Menezes Costa LC, van Tulder MW, Lin CC, Machado LA. The McKenzie method for (sub)acute non-specific low back pain. Cochrane Database Syst Rev. 2023 Apr 5;4(4):CD009711. doi: 10.1002/14651858.CD009711.pub2.
- 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.
Syed Shakil ur Rehman principal investigator
Riphah International University, Lahore, Pakistan
Maira Saeed principal investigator
Riphah International University, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan techniques with manual traction and McKenzie extension exercises with manual traction in people with 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 3 inclusion and 8 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 30 Jan 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: 4th 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 NCT06049277, which also lists 9 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 30 Jan 2024.