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

NCT ID: NCT06087107

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-01-25

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.

Conditions

Lumbar Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High Intensity Spinal Decompression Exercises

Participants in this group will receive high intensity spinal decompression exercises

Group Type: EXPERIMENTAL

High Intensity Spinal Decompression Exercises

Intervention Type: OTHER

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

Participants in this group will receive Eldoa.

Group Type: ACTIVE_COMPARATOR

Eldoa

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faiza Amjad, MPhil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Ittefaq hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 25887469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32291226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31788391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25538126 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0160 Usman Ejaz

Identifier Type: -

Identifier Source: org_study_id