Lumbar Disc HerniationNCT06076408
Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients
A study testing SNAGS with Pilates and SNAGS in people with Lumbar Disc Herniation and Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the effects of Sustained Natural Apophyseal Glides with and without Pilates on pain, range of motion and disability in patients with lumbar Disc Bulge. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Radiculopathy
- What is being tested?
- SNAGS with Pilates and SNAGS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Oct 2023to 30 Apr 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient of both gender under the age of 40-60 year.
- Unilateral radiating pain through the course of sciatic nerve
- a duration of pain of at least 3 months
- Restricted lumbar range of motion.
- Subjects who can understand the instructions and are willing to participate in the study
- Positive slump test with positive pain location and positive pain descriptors.
- Passive Lumbar Extension If the patient experiences severe low back pain or if there is a feeling of heaviness on the lower back or a feeling as though the lower back were about to 'come off' the test is considered positive.
- Straight Leg Raise SLR test positive when it evokes radiating pain along the course of the sciatic nerve and below the knee between 30 and 70 degrees of hip flexion
Who cannot join
- History of trauma, dislocation and subluxation of lower extremity.
- Rheumatoid Arthritis
- Systemic diseases such as blood coagulation disorders, chronic pain syndrome, cancer, allergies fibromyalgia, systemic lupus erythematous, and psoriatic arthritis.
- Lumbar spine surgery patients.
- Malignancy
- neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia)
- clinical diagnosis of lumbar bilateral radiculopathy or myelopathy
- history of previous physical therapy intervention for the lumbar region in last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sustained Natural Apophyseal Glides With and Without Pilates on Pain, Range of Motion and Disability in Patients With Lumbar Disc Bulge
The aim of this study is to compare the effects of Sustained Natural Apophyseal Glides with and without Pilates on pain, range of motion and disability in patients with lumbar Disc Bulge.
Read the detailed description
Lumbar disc disease may occur when a disc in the low back area of the spine bulges or herniates between the bony areas of the spine. Lumbar disk disease causes lower back pain and leg pain and weakness that is made worse by movement and activity. Lumbar disc bulge is typically managed through a multidimensional approach that integrates various therapeutic techniques aimed at reducing symptoms and enhancing functional outcomes. The use of SNAGs has been shown to produce positive results such as decreased pain levels and increased mobility in previous studies. Overall physical conditioning can be improved by using a holistic approach that consists of controlled movements combined with breathing techniques and mindfulness. In order to treat lumbar disc bulge patients more effectively, it is important to understand how use and efficacy differ when applying SNAGs alone versus together with Pilates. Delving into how combining SNAGs and Pilates affects lumbar disc bulge patients contributes to an expanding body of proof advocating for a multimodal treatment.
- Conditions
- Lumbar Disc Herniation, Lumbar Radiculopathy
- Being tested
- SNAGS with Pilates, SNAGS
- Keywords
- disability, lumbar radiculopathy, low back pain, endurance
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAGS with PilatesOther
Patients will Receive Sustained Natural Apophyseal glides and Pilates Technique. Pilates Exercises focusses on five main areas (breath control, pelvic lumbar region, chest, shoulder positioning, head and neck positioning) a special session was organized for each patient
SNAGSOther
Patients will Receive Sustained Natural Apophyseal glides
| Study group | Role | What they receive |
|---|---|---|
| SNAGS with Pilates | Experimental | Sustained Natural Apophyseal glides and Pilates Exercises Receives: Other: SNAGS with Pilates |
| SNAGS | Active comparator | Sustained Natural Apophyseal glides Receives: Other: SNAGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
NPRS scale can be used to quantify pain intensity levels. The 11-point scale ranges from '0' for the least amount of pain "no pain" to '10' for the most extreme levels of pain "pain as severe as you can imagine". It is convenient to use NPRS for patients. Its score ranges between 0-10. "change will be measured from baseline to 3 weeks"
Measured: 3 weeks
Modified Oswestry Disability Index
The ODI is a disease specific disability measure is used to establish measure a level of disability stage of patients' acuity status and monitor change over time. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. "Change will be measured from baseline to 3 weeks"
Measured: 3 weeks
Lumbar ROM by inclinometer
Inclinometer is used to measure the range of motion on Lumbar spine. "Change in ROM will be measured from baseline to 3 weeks".
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start3 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Ashraf, TDPT, Principal investigator, Riphah International UniversityAmmar Javed, MS OMPT*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076408
- Sponsor's protocol ID
- REC/0165Ammar Javed
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2023
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustained Natural Apophyseal Glides With and Without Pilates on Pain, Range of Motion and Disability in Patients With Lumbar Disc Bulge
- ClinicalTrials.gov ID
- NCT06076408
- Acronym / sponsor ID
- REC/0165Ammar Javed
- Conditions
- Lumbar Disc Herniation, Lumbar Radiculopathy
- Keywords
- disability, lumbar radiculopathy, low back pain, endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 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 Sustained Natural Apophyseal Glides with and without Pilates on pain, range of motion and disability in patients with lumbar Disc Bulge.
Detailed description
Lumbar disc disease may occur when a disc in the low back area of the spine bulges or herniates between the bony areas of the spine. Lumbar disk disease causes lower back pain and leg pain and weakness that is made worse by movement and activity. Lumbar disc bulge is typically managed through a multidimensional approach that integrates various therapeutic techniques aimed at reducing symptoms and enhancing functional outcomes. The use of SNAGs has been shown to produce positive results such as decreased pain levels and increased mobility in previous studies. Overall physical conditioning can be improved by using a holistic approach that consists of controlled movements combined with breathing techniques and mindfulness. In order to treat lumbar disc bulge patients more effectively, it is important to understand how use and efficacy differ when applying SNAGs alone versus together with Pilates. Delving into how combining SNAGs and Pilates affects lumbar disc bulge patients contributes to an expanding body of proof advocating for a multimodal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNAGS with Pilates | Experimental | Other: SNAGS with PilatesSustained Natural Apophyseal glides and Pilates Exercises |
| SNAGS | Active comparator | Other: SNAGSSustained Natural Apophyseal glides |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient of both gender under the age of 40-60 year.
- Unilateral radiating pain through the course of sciatic nerve
- a duration of pain of at least 3 months
- Restricted lumbar range of motion.
- Subjects who can understand the instructions and are willing to participate in the study
Key exclusion criteria (8 listed)
- History of trauma, dislocation and subluxation of lower extremity.
- Rheumatoid Arthritis
- Systemic diseases such as blood coagulation disorders, chronic pain syndrome, cancer, allergies fibromyalgia, systemic lupus erythematous, and psoriatic arthritis.
- Lumbar spine surgery patients.
- Malignancy
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 |
|---|---|---|
| SNAGS with PilatesPatients will Receive Sustained Natural Apophyseal glides and Pilates Technique. Pilates Exercises focusses on five main areas (breath control, pelvic lumbar region, chest, shoulder positioning, head and neck positioning) a special session was organized for each patient | Other | SNAGS with Pilates |
| SNAGSPatients will Receive Sustained Natural Apophyseal glides | Other | SNAGS |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 3 weeks
NPRS scale can be used to quantify pain intensity levels. The 11-point scale ranges from '0' for the least amount of pain "no pain" to '10' for the most extreme levels of pain "pain as severe as you can imagine". It is convenient to use NPRS for patients. Its score ranges between 0-10. "change will be measured from baseline to 3 weeks"
Modified Oswestry Disability Index
Time frame: 3 weeks
The ODI is a disease specific disability measure is used to establish measure a level of disability stage of patients' acuity status and monitor change over time. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. "Change will be measured from baseline to 3 weeks"
Lumbar ROM by inclinometer
Time frame: 3 weeks
Inclinometer is used to measure the range of motion on Lumbar spine. "Change in ROM will be measured from baseline to 3 weeks".
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 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Lumbar Disc Herniation
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Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
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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.
Faiza Ashraf, TDPT principal investigator
Riphah International University
Ammar Javed, MS OMPT* 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 SNAGS with Pilates and SNAGS in people with Lumbar Disc Herniation and Lumbar Radiculopathy, 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 8 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 8 Apr 2025. 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?
Numeric Pain Rating Scale (NPRS) (time frame: 3 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?
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 8 Apr 2025.