NCT05654428

Brief Summary

Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Occurrence rate of Lumbosacral radiculopathy is 3-5% distributed equally in men and women affecting more men than women. It commonly occurs in late 40s in men and late 50s-60s in females. Men are more prone to develop lumbosacral radiculopathy due to mechanical disturbance during routine work.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

December 7, 2022

Last Update Submit

February 1, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale

    0 means no pain and 10 means worst pain ever felt

    4 weeks

  • Flexi curve ruler

    to measure the lumber cure

    4 weeks

  • Bubble inclinometer

    Measure the cure

    4 weeks

  • King Health Questionnaire quality of life

    lesser score means low quality of life and higher score means better quality of life

    4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: Mckenzie Extension * Prone press-ups * Head life in prone * Prone on elbow * Prone on hands * Prone on pillow

Other: Mckenzie Extension Exercises

Control Group

ACTIVE COMPARATOR

55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: William Flexion * Single knee to chest * Double knee to chest * Straight Leg Raise * Bridging * Pelvic tilt

Other: William Flexion Exercises

Interventions

The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone.

Experimental Group

Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).

Control Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females with age between 40-60 years
  • Patients referred from neuro and orthopedic departments with diagnosed lumbosacral radiculopathy.
  • Complaint of low back pain on walk, bending and after long sitting with positive slump test.
  • Complaint of low back pain, and numbness and tingling in leg with positive SLR test

You may not qualify if:

  • Lumbar Trauma
  • Any other orthopedic and neurological conditions of hip and lumbosacral spine.
  • Hip Fracture
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isra niversity

Islamabad, Federal, 46030, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Just Participants are unaware about which type of intervention they are being underwent.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Control Trail with 2 Equal groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal researcher

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 16, 2022

Study Start

September 22, 2022

Primary Completion

January 21, 2023

Study Completion

February 1, 2023

Last Updated

February 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations