NCT05659342

Brief Summary

To compare the effect of ELDOA and Mechanical traction technique on pain in patients with lumbar disc herniation. To compare the effect of ELDOA and Mechanical traction technique on disability in patients with lumbar disc herniation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

March 5, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

December 13, 2022

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • lumbar ROM by inclinometer.

    Flexion 60 Extension 25 Left Lat Flex 25 Right Lat Flex 25

    4 weeks

  • pain on Numeric pain rating scale

    Changes from baseline, Pain was measured through Numeric pain rating scale.It comprises of a continuous scale of 10cm line.0 to 1 represent no pain, 1 to 3 represent mild pain ,4 to 6 represent moderate pain, 7 to 10 represent severe pain

    4 Weeks

  • Modified Oswestry low back pain disability questionnaire

    0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%:These patients are either bed-bound or exaggerating their symptoms

    4th Week

Study Arms (2)

ELDOA Technique

EXPERIMENTAL

ELDOA positions (hold for 1 minute, 3 alternative days for 4 weeks). Hot pack (10-15 minutes) McKenzie extension Exercises

Other: ELDOA Technique

Mechanical Lumbar Traction

EXPERIMENTAL

Mechanical Lumbar Traction (50% of body weight was applied, in supine position, the hip and knee at 90- degree flexion, and the legs were supported. Hot pack (10-15 minutes) McKenzie extension Exercises

Other: Mechanical Lumbar Traction

Interventions

the patients treated with ELDOA technique, followed for 3 alternative days for 4 weeks. the ELDOA techniques for level L4/L5 and L5/S1 were applied. the ELDOA positions hold for one minute, 3 alternative days for 4 weeks under supervision. Hot pack (10-15 minutes) McKenzie Extension Exercises

ELDOA Technique

Mechanical Traction Technique: traction unit, 50% of body weight was applied with the patients lying in supine position, with the hip and knee at 90 degree flexion, and legs were supported. Traction were applied for 3 alternative days for 4 weeks. Hot pack (10-15 minutes) McKenzie Extension Exercises

Mechanical Lumbar Traction

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 20-65 years
  • Both gender Male \& Female
  • Patients having Lumbar radiculopathy diagnosed with lumbar disc herniation.

You may not qualify if:

  • Patients presented with motor deficit,
  • Qauda equina syndrome,
  • lumbar fracture
  • spinal stenosis,
  • osteophyte formation
  • facet joint pathology
  • spondylolisthesis.
  • malignancy,
  • degenerative disorders
  • recent back surgery and patient whom surgery for lumbar disc herniation/prolapse intervertebral disc already advised by neurosurgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital - Medical Teaching Institution

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Asghar Khan, DCS-PT

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

March 5, 2020

Primary Completion

January 4, 2021

Study Completion

January 4, 2021

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations