Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

ELDOA Technique

Mechanical Lumbar Traction

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lady Reading Hospital - Medical Teaching Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ELDOA Technique

Mechanical Lumbar Traction

Arm Description

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

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

Outcomes

Primary Outcome Measures

lumbar ROM by inclinometer.

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05659342

First Posted

December 13, 2022

Last Updated

January 31, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05659342

Brief Title

Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation

Official Title

Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

March 5, 2020 (Actual)

Primary Completion Date

January 4, 2021 (Actual)

Study Completion Date

January 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Disc Herniation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ELDOA Technique

Arm Type

Experimental

Arm Description

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

Arm Title

Mechanical Lumbar Traction

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

ELDOA Technique

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Mechanical Lumbar Traction

Intervention Description

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

Primary Outcome Measure Information:

Title

lumbar ROM by inclinometer.

Description

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

Time Frame

4 weeks

Title

pain on Numeric pain rating scale

Description

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

Time Frame

4 Weeks

Title

Modified Oswestry low back pain disability questionnaire

Description

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

Time Frame

4th Week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asghar Khan, DCS-PT

Organizational Affiliation

Riphah International University

Official's Role

Study Chair

Facility Information:

Facility Name

Lady Reading Hospital - Medical Teaching Institution

City

Peshawar

State/Province

KP

ZIP/Postal Code

25000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

No

Lumbar Disc Herniation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial