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

Lumbar Radiculopathy Clinical Trial

Official title:

Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa On Pain, Range Of Motion And Disability In Patients Of Lumbar Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06087107
• Other study ID #: REC/RCR&AHS/23/0160 Usman Ejaz
• Status: Completed
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of high intensity spinal decompression exercises and Eldoa on pain, ROM and Disability in patients of lumbar radiculopathy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 25, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Other:
• High Intensity Spinal Decompression Exercises
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.
• Eldoa
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.

Locations

Country	Name	City	State
Pakistan	Ittefaq hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4th week
Primary	Range of motion spine (flexion)	Changes from baseline ROM range of motion of spinal flexion will be taken with the help of inclinometer	4th week
Primary	Range of Motion Spine (Extension)	Changes from baseline ROM range of motion of spinal extension will be taken with the help of inclinometer	4th week
Primary	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	4th week
Primary	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	4th week
Primary	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	4th week
Primary	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	4th week
Primary	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.	4th week