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Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High Intensity Spinal Decompression Exercises
Eldoa
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Radiculopathy, Decompression, Pain, Range of motion

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants pre-diagnosed with lumber radiculopathy Women and men between the age of 25 to 45 years Participants with chronic low back pain radiated to one or both legs Exclusion Criteria: Diagnosed with Spinal tumour Diagnosed with Lumbar spine surgery Diagnosed with Lumbar spondylolisthesis Diagnosed with Fracture of lumbar spine Diagnosed with Ankylosing spondylitis Diagnosed with Pacemaker & Taking blood thinner medication

Sites / Locations

  • Ittefaq hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Spinal Decompression Exercises

Eldoa

Arm Description

Participants in this group will receive high intensity spinal decompression exercises

Participants in this group will receive Eldoa.

Outcomes

Primary Outcome Measures

Pain(NPRS)
Changes from the baseline 11-point NPRS is used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be valid and reliable with validity range from 0.86 to 0.95 and reliability r=0.96 and 0.95 with intraclass correlation coefficient of 0.95
Range of motion spine (flexion)
Changes from baseline ROM range of motion of spinal flexion will be taken with the help of inclinometer
Range of Motion Spine (Extension)
Changes from baseline ROM range of motion of spinal extension will be taken with the help of inclinometer
Range of Motion Spine (Right side bending)
Changes from baseline ROM range of motion of spinal right side bending will be taken with the help of inclinometer
Range of Motion Spine (left side bending)
Changes from baseline ROM range of motion of spinal left side bending will be taken with the help of inclinometer
Range of Motion Spine (right side rotation)
Changes from baseline ROM range of motion of spinal right side rotation will be taken with the help of inclinometer
Range of Motion Spine (left side rotation)
Changes from baseline ROM range of motion of spinal left side rotation will be taken with the help of inclinometer
Disability: Oswestry disability index questionnaire (ODI)
Changes from baseline ODI.is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools interpretation of score are mentioned in the study.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06087107
Brief Title
Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy
Official Title
Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa On Pain, Range Of Motion And Disability In Patients Of Lumbar Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)

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 effects of high intensity spinal decompression exercises and Eldoa on pain, ROM and Disability in patients of lumbar radiculopathy.
Detailed Description
In year 2020, a study conducted on the effect of eldoa alone and eldoa with core muscle strengthening to treat pain in patients with PIVD to determine the best treatment protocol between core muscle strengthening with and without eldoa to treat pain the numeric pain rating scale was used to measure pain. The study was done on 30 females randomly placed in two groups. The patients were treated for 3 days in a week on alternate days, for six consecutive weeks The eldoa technique was used segmentally on spine with different position as for l5-s1, patient flattens spine, curls back the toes curled back, inverses the ankles, internally rotates the hip, swings the arms up over the head while maintaining tension in same position as for l4-l5. Both reported decrease in pain intensity on NPRS at 6th week. So, results suggest that there was no significant difference between the effectiveness of techniques on reducing intensity of pain on NPRS. In year 2021, a study conducted on effects of decompression and eldoa on pain and disability in lumbar disc protrusion. This study was done on 122 patients with the history of prolong sitting divided in two groups, one group was given decompression therapy and other group was treated with Eldoa which concluded that the pain could be significantly decreased while applying ELDOA for the patients with disc pathologies in musicians when assess pre and posttreatment. Likewise in this study, the quality of life of participants was significantly improved after the administration of ELDOA therapy. In year 2022, RCT conducted on the effects of McKenzie extension exercise and ELDOA stretch in non-specific low back pain patients at railway general hospital, Rawalpindi and IRADA rehabilitation center. 48 female participants with the age range of 40-69 years and had chronic non-specific low back pain for more than 3 months were included in the study. Both groups were assessed at baseline score of ODI, BMI, NPRs after 2nd week and 4th week. According to this , McKenzie extension exercises significantly improved nonspecific low back pain and lumbar extension ROM. In year 2022, a study conducted on effects of ELDOA Technique with Conservative Treatment on Pain Threshold of Active Trigger Points in Upper Trapezius and Levator Scpulae. She included 26 participants in her study and divided it into two groups. She measured pain, range of motion and disability after treatment. After analysis, results of her study showed that eldoa approach reduced discomfort, cervical ranges and neck impairment brought on by trigger points. There is limited literature available regarding the effects of High intensity spinal decompression exercises and ELDOA therapy in patients with lumbar radiculopathy. Previous literature did not include the side bending and rotation component of range of motion and comparison between those two techniques. Therefore, in this study effects of ELDOA therapy will be compared with spinal decompression exercise to improve pain and range of motion and function in patients with lumbar radiculopathy and also include home plan after the session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Radiculopathy, Decompression, Pain, Range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
Masking
Participant
Masking Description
single blinding
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Spinal Decompression Exercises
Arm Type
Experimental
Arm Description
Participants in this group will receive high intensity spinal decompression exercises
Arm Title
Eldoa
Arm Type
Active Comparator
Arm Description
Participants in this group will receive Eldoa.
Intervention Type
Other
Intervention Name(s)
High Intensity Spinal Decompression Exercises
Intervention Description
The duration of the intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 40 minutes with 8-10 repetitions of each exercise.
Intervention Type
Other
Intervention Name(s)
Eldoa
Intervention Description
The duration of the intervention will be 4 weeks, 3 sessions a week, and a total of 12 sessions will be given to the study participants. Each session will last for 40 minutes.
Primary Outcome Measure Information:
Title
Pain(NPRS)
Description
Changes from the baseline 11-point NPRS is used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be valid and reliable with validity range from 0.86 to 0.95 and reliability r=0.96 and 0.95 with intraclass correlation coefficient of 0.95
Time Frame
4th week
Title
Range of motion spine (flexion)
Description
Changes from baseline ROM range of motion of spinal flexion will be taken with the help of inclinometer
Time Frame
4th week
Title
Range of Motion Spine (Extension)
Description
Changes from baseline ROM range of motion of spinal extension will be taken with the help of inclinometer
Time Frame
4th week
Title
Range of Motion Spine (Right side bending)
Description
Changes from baseline ROM range of motion of spinal right side bending will be taken with the help of inclinometer
Time Frame
4th week
Title
Range of Motion Spine (left side bending)
Description
Changes from baseline ROM range of motion of spinal left side bending will be taken with the help of inclinometer
Time Frame
4th week
Title
Range of Motion Spine (right side rotation)
Description
Changes from baseline ROM range of motion of spinal right side rotation will be taken with the help of inclinometer
Time Frame
4th week
Title
Range of Motion Spine (left side rotation)
Description
Changes from baseline ROM range of motion of spinal left side rotation will be taken with the help of inclinometer
Time Frame
4th week
Title
Disability: Oswestry disability index questionnaire (ODI)
Description
Changes from baseline ODI.is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools interpretation of score are mentioned in the study.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants pre-diagnosed with lumber radiculopathy Women and men between the age of 25 to 45 years Participants with chronic low back pain radiated to one or both legs Exclusion Criteria: Diagnosed with Spinal tumour Diagnosed with Lumbar spine surgery Diagnosed with Lumbar spondylolisthesis Diagnosed with Fracture of lumbar spine Diagnosed with Ankylosing spondylitis Diagnosed with Pacemaker & Taking blood thinner medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faiza Amjad, MPhil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ittefaq hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faiza Amjad, MPhil
Phone
03338013182
Email
faiza.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Usman Ejaz, MS OMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25887469
Citation
Iversen T, Solberg TK, Wilsgaard T, Waterloo K, Brox JI, Ingebrigtsen T. Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study. BMC Musculoskelet Disord. 2015 Feb 7;16(1):17. doi: 10.1186/s12891-015-0474-9.
Results Reference
background
PubMed Identifier
32291226
Citation
Ostelo RW. Physiotherapy management of sciatica. J Physiother. 2020 Apr;66(2):83-88. doi: 10.1016/j.jphys.2020.03.005. Epub 2020 Apr 11. No abstract available.
Results Reference
background
PubMed Identifier
31788391
Citation
Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
Results Reference
background
PubMed Identifier
25538126
Citation
Grimm BD, Blessinger BJ, Darden BV, Brigham CD, Kneisl JS, Laxer EB. Mimickers of lumbar radiculopathy. J Am Acad Orthop Surg. 2015 Jan;23(1):7-17. doi: 10.5435/JAAOS-23-01-7.
Results Reference
background

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Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy

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