Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain

Low Back Pain, Mechanical Clinical Trial

Official title:

Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108661
• Other study ID #: FUI/CTR/2023/21
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: October 2023
• Source: Foundation University Islamabad
• Contact: Maheen Farooq, MS-MSKPT*
• Phone: 03354222508
• Email: mahe.farooq1896[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 15, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Procedure:
• Conventional Physical Therapy
Moist heat therapy for 10 minutes for 3 times per week (alternatively) for 2 weeks. TENS was applied for 15 minutes, 3 times per week (alternatively) for 2 weeks. Stretching protocol for deep lumbar spinal muscles was employed. The frequency was 3 times per week (alternatively) for 2 weeks.
• Slump Stretching
Slump stretching will be performed with the patient in the long sitting position with the patient's feet against the wall to assure the ankle remained in 0 degree dorsiflexion. The therapist will apply over pressure to the cervical spine flexion to the point where the patient's symptoms will be reproduced. The position will be held for 30 s. A total of 5 repetitions will be completed.
• ELDOA
ELDOA will be performed as per the tolerance of the patient (Max hold time=60sec) for 2 weeks (alternatively). For L4/L5 spinal segment patient sits on the floor, arms at the side legs relaxed. For L5/S1 segment the patient lies on his or her side with torso perpendicular to a wall with the sitz bone pressing into the wall. The patient swing the legs up so that he or she is lying on his or her back with the legs perpendicular up the wall and the sitz bone pressing into the wall. The arms are lying by the sides.

Locations

Country	Name	City	State
Pakistan	Foundation University College of Physical Therapy	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar ROM	Inclinometer will be used to measure the lumbar ROM. One inclinometer is placed on T12 spinous process and the second inclinometer is placed on S1 spinous process of participant. The patient is asked to perform forward flexion, extension and lateral flexion, The range of motion is recorded by subtracting the value on lower inclinometer from upper inclinometer	2 weeks
Primary	Gait speed:	Gait speed = distance(m) x time(s)	2 weeks
Primary	Cycle time	Cycle time(s) = time(s) x2/steps counted	2 weeks
Primary	Cadence	Cadence(steps/min) = steps counted x 60/time(s)	2 weeks
Primary	Stride Length	SL (m)=Speed(m/s)x cycle time(s)	2 weeks
Primary	Pain intensity	The numeric pain rating scale is a pain assessment tool that is self-reported or given by a clinician and consists of a numerical point scale with extreme values ranging from "no pain" to "severe pain." O means no pain whereas 10 means severe pain.	2 weeks