Clinical trial NCT06108661: Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain
Official title: Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial which will consist of two groups. Once will receive conventional physical therapy and the second will receive conventional physical therapy and slump stretching. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: The title of this study is Shirt term effects of ELDOA and slump steyching in mechanical low back pain. Previous studies have identified the effects of ELDOA and slump stretching on mechanical low back pain, but their short term effects have not been compared. This study will focus on the comparison of these techniques and their effectiveness in patients with mechanical low back pain. The purpose of this study is to compare the short term effects of ELDOA and slump stretching on spatiotemporal gait parameters, lumbar ROM and pain in patients with mechanical low back pain.

Spatiotemporal gait parameters will be measured by using formulas. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method. ELODA and slump stretching will be given to groups A and B respectively, along with conventional physical therapy treatment. Inclinometer, NPRS and formulas for spatiotemporal gait parameters will be used as outcome measures.

Detailed description: Low back pain is one of the most prevalent musculoskeletal conditions worldwide. Amongst the general population, more than 70% of the people experience low back pain at some time in their lifetime. The prevalence of low back pain was found to be 32%,52%,96%,72.8 %,72.9%, 56.6%,56.25%, 69 % in school teachers, bankers, dentists, nurses, clinical physical therapist, health science students, Salesmen and computer users respectively in Pakistan. Low back pain is pain or discomfort in the lumbosacral region from the lower costal margin to the inferior gluteal fold.

This randomized control trial will be conducted in MDL2 of Foundation University College of Physical Therapy using non-probability purposive sampling. Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw. Written informed consent will be taken from all the participants before conducting the research. Details of exercise program will be explained to them. Diagnostic tests will be applied to confirm the Low back pain. Slump test will be used for this purpose. Then the selected participants will be randomized into 2 groups(experimental group and control group)via lottery method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain. Lumbar ROM and spatiotemporal gait parameters will be noted. All of these measurements will be taken at baseline, after 1 week and then after 2 weeks of intervention.

The treatment protocol of both groups is as follows:

Group 1(Experimental group): Conservative management including hot pack, TENS and muscle stretching along with ELDOA (each position will be maintained as per the tolerance of the patient).

Group 2(Control group): Conservative management including hot pack, TENS and muscle stretching along with slump stretching (position will be maintained as per the tolerance of the patient).

Eligibility criteria: Inclusion Criteria:

* Age group: 18-45 years old
* Both males and females
* Patients with pain intensity of at least 5 on NPRS
* Positive slump test

Exclusion Criteria:

* Any congenital deformities
* Demonstrated neurological deficit
* Pregnant females
* History of spinal surgery
* Spondylolisthesis
* Severe lumbar spondylosis
* Spinal stenosis
* Disc herniation
* Serious spinal conditions like infection, tumors, osteoporosis, spinal fracture
* Limb length discrepancy
* Sacroiliac and hip disorder

Primary outcomes:
measure: Lumbar ROM
timeFrame: 2 weeks
measure: Gait speed:
timeFrame: 2 weeks
measure: Cycle time
timeFrame: 2 weeks
measure: Cadence
timeFrame: 2 weeks
measure: Stride Length
timeFrame: 2 weeks
measure: Pain intensity
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References: