Back to resultsEffects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients
Primary Purpose
Lumbar Disc Herniation, Lumbar Radiculopathy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
SNAGS with Pilates
SNAGS
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring disability, lumbar radiculopathy, low back pain, endurance
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Bakhtawar Amin Hospital MultanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SNAGS with Pilates
SNAGS
Arm Description
Sustained Natural Apophyseal glides and Pilates Exercises
Sustained Natural Apophyseal glides
Outcomes
Primary Outcome Measures
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"
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"
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT06076408
First Posted
October 4, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT06076408
Brief Title
Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Lumbar Radiculopathy
Keywords
disability, lumbar radiculopathy, low back pain, endurance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SNAGS with Pilates
Arm Type
Experimental
Arm Description
Sustained Natural Apophyseal glides and Pilates Exercises
Arm Title
SNAGS
Arm Type
Active Comparator
Arm Description
Sustained Natural Apophyseal glides
Intervention Type
Other
Intervention Name(s)
SNAGS with Pilates
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
SNAGS
Intervention Description
Patients will Receive Sustained Natural Apophyseal glides
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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"
Time Frame
3 weeks
Title
Modified Oswestry Disability Index
Description
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"
Time Frame
3 weeks
Title
Lumbar ROM by inclinometer
Description
Inclinometer is used to measure the range of motion on Lumbar spine. "Change in ROM will be measured from baseline to 3 weeks".
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aruba Saeed, PHD*
Phone
03344399403
Email
aruba.saeed@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Faiza Ashraf, TDPT
Phone
03327673643
Email
dr.faiza1234@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faiza Ashraf, TDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ammar Javed, MS OMPT*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakhtawar Amin Hospital Multan
City
Multan
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faiza Ashraf, TDPT
Phone
03327673643
Email
dr.faiza1234@gmail.com
First Name & Middle Initial & Last Name & Degree
Ammar Javed, MS OMPT*
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients
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