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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06076408
Other study ID # REC/0165Ammar Javed
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2023
Est. completion date April 2024

Study information

Verified date October 2023
Source Riphah International University
Contact Aruba Saeed, PHD*
Phone 03344399403
Email aruba.saeed@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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

Study Design


Intervention

Other:
SNAGS with Pilates
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
SNAGS
Patients will Receive Sustained Natural Apophyseal glides

Locations

Country Name City State
Pakistan Bakhtawar Amin Hospital Multan Multan Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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" 3 weeks
Primary 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" 3 weeks
Primary 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". 3 weeks
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