Effects of ELDOA and Slump Stretching on Mechanical Low Back Pain

NCT06108661 | Unknown

• 1 other identifier: FUI/CTR/2023/21
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (6)

• 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

• Gait speed:

  Gait speed = distance(m) x time(s)

  2 weeks

• Cycle time

  Cycle time(s) = time(s) x2/steps counted

  2 weeks

• Cadence

  Cadence(steps/min) = steps counted x 60/time(s)

  2 weeks

• Stride Length

  SL (m)=Speed(m/s)x cycle time(s)

  2 weeks

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Treatment protocol given to both groups will be carried out for 3 sessions per week for 2 weeks. It will comprise of hot pack for 10 minutes in prone position. Stretching protocol for shortened muscles. Frequency would be: 3 times per week (alternatively) for 1st week and 2nd week. ELDOA. As per the tolerance of the patient. (Max hold time=60sec) For 2 weeks (alternatively).

Procedure: Conventional Physical Therapy; Procedure: ELDOA

Group B

ACTIVE COMPARATOR

Treatment protocol given to both groups will be carried out for 3 sessions per week for 2 weeks. It will comprise of hot pack for 10 minutes. Stretching protocol for shortened muscles. Frequency would be: 3 times per week (alternatively) for 1st week and 2nd week. 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

Procedure: Conventional Physical Therapy; Procedure: Slump Stretching

Interventions

Conventional Physical Therapy PROCEDURE

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.

Group A; Group B

Slump Stretching PROCEDURE

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.

Group B

ELDOA PROCEDURE

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.

Group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maheen Farooq, MS-MSKPT*

CONTACT

03354222508; mahe.farooq1896@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be a another person who will be unaware of the group the participant belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: March 7, 2023
• Primary Completion: December 5, 2023
• Study Completion: December 15, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

PA (1)