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

NCT06087107 | Completed

• 1 other identifier: REC/RCR&AHS/23/0160 Usman Ejaz
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Radiculopathy

Keywords

Radiculopathy; Decompression; Pain; Range of motion

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

High Intensity Spinal Decompression Exercises

EXPERIMENTAL

Participants in this group will receive high intensity spinal decompression exercises

Other: High Intensity Spinal Decompression Exercises

Eldoa

ACTIVE COMPARATOR

Participants in this group will receive Eldoa.

Other: Eldoa

Interventions

High Intensity Spinal Decompression Exercises 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.

High Intensity Spinal Decompression Exercises

Eldoa 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.

Eldoa

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ittefaq hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 25887469 BACKGROUND

• 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.

  PMID: 32291226 BACKGROUND

• 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.

  PMID: 31788391 BACKGROUND

• 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.

  PMID: 25538126 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Faiza Amjad, MPhil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 20, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 25, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)