Low Back PainNCT05314049
Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain
A study testing Mckenzie Extension Protocol, Lumbar SNAGs and inferential therapy in people with Low Back Pain and Disk Prolapse, run by Foundation University Islamabad.
Trial summary
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Disk Prolapse, Disk Herniated Lumbar
- What is being tested?
- Mckenzie Extension Protocol, Lumbar SNAGs and inferential therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Oct 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female participants
- aged 18-50 years old
- low back pain intensity less than 80/100mm on visual analogue scale
- positive centralization phenomenon
- low signal intensity of IV disc on T2 - weighted MRI
- high intensity zone towards the posterior aspect of the disc on MRI
Who cannot join
- Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.
- -
Trial locations and contacts
No sites are listed yet.
Muhammad Osama, PhD* contact
About this study
Official title: Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.
- Being tested
- Mckenzie Extension Protocol, Lumbar SNAGs, inferential therapy, Heat Therapy
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie Extension ProtocolProcedure or surgery
Mckenzie Extension Exercise Protocol will be performed by participants in prone position
Lumbar SNAGsProcedure or surgery
Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position
inferential therapyDevice
4 pole inferential therapy in combination with superficial heating for 20 minutes
Heat TherapyDevice
superficial heating for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Procedure: Mckenzie Extension Protocol; Procedure: Lumbar SNAGs; Device: inferential therapy; Device: Heat Therapy |
| Active Comparator Group | Active comparator | Not described Receives: Procedure: Mckenzie Extension Protocol; Device: inferential therapy; Device: Heat Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back Pain
Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
Measured: 2 weeks
Lumbar Range of Motion
Disability will be measured via inclinometer. A higher score signifies good outcome.
Measured: 2 weeks
Postural Stability
Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
Measured: 2 weeks
Lumbar Disability
Disability will be measured via Oswestry Disability Index.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314049
- Sponsor's protocol ID
- FUI/CTR/2022/4
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT05314049
- Acronym / sponsor ID
- FUI/CTR/2022/4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 6 Apr 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.
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Mckenzie Extension Protocol, Procedure: Lumbar SNAGs, Device: inferential therapy, Device: Heat Therapy |
| Active Comparator Group | Active comparator | Procedure: Mckenzie Extension Protocol, Device: inferential therapy, Device: Heat Therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both male and female participants
- aged 18-50 years old
- low back pain intensity less than 80/100mm on visual analogue scale
- positive centralization phenomenon
- low signal intensity of IV disc on T2 - weighted MRI
Key exclusion criteria (2 listed)
- Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.
- -
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 |
|---|---|---|
| Mckenzie Extension ProtocolMckenzie Extension Exercise Protocol will be performed by participants in prone position | Procedure or surgery | Active Comparator Group, Experimental Group |
| Lumbar SNAGsLumbar SNAGs will be performed in lumbar flexion and extension in standing Position | Procedure or surgery | Experimental Group |
| inferential therapy4 pole inferential therapy in combination with superficial heating for 20 minutes | Device | Active Comparator Group, Experimental Group |
| Heat Therapysuperficial heating for 20 minutes | Device | Active Comparator Group, Experimental Group |
Primary outcome
Back Pain
Time frame: 2 weeks
Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
Lumbar Range of Motion
Time frame: 2 weeks
Disability will be measured via inclinometer. A higher score signifies good outcome.
Postural Stability
Time frame: 2 weeks
Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
Lumbar Disability
Time frame: 2 weeks
Disability will be measured via Oswestry Disability Index.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Muhammad Osama, PhD* contact
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie Extension Protocol, Lumbar SNAGs and inferential therapy in people with Low Back Pain and Disk Prolapse, run by Foundation University Islamabad.
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 6 inclusion and 2 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Muhammad Osama, PhD* (+923325540436, osama@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back Pain (time frame: 2 weeks). 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?
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 6 Apr 2022.