Low Back PainNCT05326594
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With 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 at 1 site in Pakistan.
Trial summary
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. Read more about this study
- Who is it for?
- Ages 18 months to 50 years
- Conditions the study is for
- Low Back Pain, Disk Prolapse
- 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
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2022to 30 Jun 2023
- 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 months to 50 years
- All sexes
- No healthy volunteers
- Child, 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
1 site in 1 country.
About this study
Official title: Effects of Physical Therapy on Improving Disc Height Index, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.
- Conditions
- Low Back Pain, Disk Prolapse
- 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 TherapyProcedure or surgery
superficial heating for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Experimental | Not described Receives: Procedure: Mckenzie Extension Protocol; Procedure: Lumbar SNAGs; Device: Inferential therapy; Procedure: 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
Lumbar Range of Motion 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
Step length
Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome
Measured: 2 weeks
Stride length
Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome
Measured: 2 weeks
Gait velocity
Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome
Measured: 2 weeks
Disc Height
Disc will be analyzed using Magnetic Resonance Imaging
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 posted13 Apr 2022
- Study start1 May 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, PhD*, Principal investigator, FUIAamer Naeem, PhD*, Principal investigator, FUI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326594
- Sponsor's protocol ID
- FUI/CTR/2022/5
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osama M, Naeem A, Tariq S, Mushtaq S, Siddiqi FA, Afridi S. Effects of physical therapy on improving disc height index, postural stability, pain and function in persons with discogenic low back pain. J Pak Med Assoc. 2025 Mar;75(3):378-382. doi: 10.47391/JPMA.20384.
PubMed 40143467
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on Improving Disc Height Index, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT05326594
- Acronym / sponsor ID
- FUI/CTR/2022/5
- Conditions
- Low Back Pain, Disk Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 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, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Experimental | Procedure: Mckenzie Extension Protocol, Procedure: Lumbar SNAGs, Device: Inferential therapy, Procedure: Heat Therapy |
Who may qualify
- Ages
- 18 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 (1 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 | Physical Therapy |
| Lumbar SNAGsLumbar SNAGs will be performed in lumbar flexion and extension in standing Position | Procedure or surgery | Physical Therapy |
| Inferential therapy4 pole inferential therapy in combination with superficial heating for 20 minutes | Device | Physical Therapy |
| Heat Therapysuperficial heating for 20 minutes | Procedure or surgery | Physical Therapy |
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
Lumbar Range of Motion 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.
Step length
Time frame: 2 weeks
Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome
Stride length
Time frame: 2 weeks
Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome
Gait velocity
Time frame: 2 weeks
Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome
Disc Height
Time frame: 2 weeks
Disc will be analyzed using Magnetic Resonance Imaging
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 28 Feb 2024.
- Derived from this study: PubMed 40143467Osama M, Naeem A, Tariq S, Mushtaq S, Siddiqi FA, Afridi S. Effects of physical therapy on improving disc height index, postural stability, pain and function in persons with discogenic low back pain. J Pak Med Assoc. 2025 Mar;75(3):378-382. doi: 10.47391/JPMA.20384.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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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.
Muhammad Osama, PhD* principal investigator
FUI
Aamer Naeem, PhD* principal investigator
FUI
1 site in 1 country: see every site and its status.
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 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 6 inclusion and 1 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 28 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?
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?
Back Pain (time frame: 2 weeks). The study lists 8 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 NCT05326594, which also lists 1 linked publication.
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 28 Feb 2024.