Herniation, DiscDISC-RELIEFNCT06534593
Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation
A study testing Standard medical treatment, Lumbar Traction and Mckenzie Extension Protocol in people with Herniation, Disc and Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Herniation, Disc, Low Back Pain
- What is being tested?
- Standard medical treatment, Lumbar Traction and Mckenzie Extension Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Aug 2024to 7 Feb 2025
- 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
- Postero-lateral lumbar disc herniation
- Aged 18-50 years old
- Low back pain intensity less than 80/100mm on visual analogue scale or 8/10 on numeric pain rating scale
- Positive peripheralization and centralization phenomenon
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 Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation: The DISC-RELIEF Trial
The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.
- Conditions
- Herniation, Disc, Low Back Pain
- Being tested
- Standard medical treatment, Lumbar Traction, Mckenzie Extension Protocol, Interferential Therapy, Heat Therapy
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical treatmentOther
Standard medical treatment
Lumbar TractionDevice
Lumbar traction using traction table
Mckenzie Extension ProtocolOther
Mckenzie Extension Exercises
Interferential TherapyDevice
Interferential Therapy for 20 minutes
Heat TherapyDevice
Heat Therapy for 20 minutes
Sustained Natural Apophyseal Glides (SNAGs)Other
3-5 reptations of Mulligan's lumbar extension Sustained Natural Apophyseal Glides (SNAGs)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The Control group will receive standard treatment for the management of discogenic low back pain. Receives: Other: Standard medical treatment |
| Experimental Group | Experimental | The Physical Therapy group will receive Physical Therapy for the management of discogenic low back pain. Receives: Device: Lumbar Traction; Other: Mckenzie Extension Protocol; Device: Interferential Therapy; Device: Heat Therapy; Other: Sustained Natural Apophyseal Glides (SNAGs) |
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
Lumbar Disability will be measured via Oswestry Disability Index.
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
Cadence
Cadence during gait will be analyzed using observational gait analysis, which is number of steps per minute.
Measured: 2 weeks
Disc height index
Disc height index will be analyzed using Magnetic Resonance Imaging. A greater disc height index signifies better outcome
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 posted2 Aug 2024
- Study start7 Aug 2024 (estimated)
- Primary completion7 Feb 2025 (estimated)
- Study completion7 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniation, DiscStudies 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
- Model description
- the study will consist of 2 arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, PhD*, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534593
- Sponsor's protocol ID
- FUI/CTR/2024/16
- Acronym
- DISC-RELIEF
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation: The DISC-RELIEF Trial
- ClinicalTrials.gov ID
- NCT06534593
- Acronym / sponsor ID
- DISC-RELIEF / FUI/CTR/2024/16
- Conditions
- Herniation, Disc, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 7 Aug 2024 (estimated)
- Primary completion
- 7 Feb 2025 (estimated)
- Study completion
- 7 Feb 2025 (estimated)
- First posted
- 2 Aug 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 current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the study will consist of 2 arms.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard medical treatmentThe Control group will receive standard treatment for the management of discogenic low back pain. |
| Experimental Group | Experimental | Device: Lumbar Traction, Other: Mckenzie Extension Protocol, Device: Interferential Therapy, Device: Heat Therapy, Other: Sustained Natural Apophyseal Glides (SNAGs)The Physical Therapy group will receive Physical Therapy for the management of discogenic low back pain. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female participants
- Postero-lateral lumbar disc herniation
- Aged 18-50 years old
- Low back pain intensity less than 80/100mm on visual analogue scale or 8/10 on numeric pain rating scale
- Positive peripheralization and centralization phenomenon
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 |
|---|---|---|
| Standard medical treatmentStandard medical treatment | Other | Control Group |
| Lumbar TractionLumbar traction using traction table | Device | Experimental Group |
| Mckenzie Extension ProtocolMckenzie Extension Exercises | Other | Experimental Group |
| Interferential TherapyInterferential Therapy for 20 minutes | Device | Experimental Group |
| Heat TherapyHeat Therapy for 20 minutes | Device | Experimental Group |
| Sustained Natural Apophyseal Glides (SNAGs)3-5 reptations of Mulligan's lumbar extension Sustained Natural Apophyseal Glides (SNAGs) | Other | 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
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
Lumbar Disability will be measured via Oswestry Disability Index.
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
Cadence
Time frame: 2 weeks
Cadence during gait will be analyzed using observational gait analysis, which is number of steps per minute.
Disc height index
Time frame: 2 weeks
Disc height index will be analyzed using Magnetic Resonance Imaging. A greater disc height index signifies better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical treatment, Lumbar Traction and Mckenzie Extension Protocol in people with Herniation, Disc and Low Back Pain, 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 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 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?
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?
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 2 Aug 2024.