NCT04681716

Brief Summary

ELDOA is the most beneficial intervention treating for lumbar pathologies such as radiculopathy. This study was a randomized control trial in which data was collected from Riphah Rehabilitation and Research Centre and Pakistan Railway Hospital-IIMCT. Purposive sampling technique was used for data collection. Research data was recorded by using prescribed validated questionnaire, NPRS and ODI. After taking consent from patients, patients were divided randomly in two groups through lottery method. Group A was treated with ELDOA and mobilization, group B was treated with only mobilization. It was observed that both groups showed improvement but ELDOA group showed more significant results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

November 27, 2020

Last Update Submit

September 2, 2021

Conditions

Lumbar Radiculopathy

Keywords

ELDOAmobilizationlumber radiculopathyNPRSODI

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in individuals. in which patient selects a number (0-10) from a horizontal line that best reflects the intensity of their pain, with 0 representing no pain and 10 representing pain as bad as one can imagine or worst pain imaginable. The number that the patient point to on the scale to rate their pain intensity is recorded. Higher scores indicate greater pain intensity. NPRS was used and patients were asked to rate their pain before the first treatment session and then at the end of last treatment session.

    immediately after intervention

Secondary Outcomes (1)

  • Oswestry Disability Index (Modified ODI) for Low Back Pain

    immediately after intervention

Study Arms (2)

ELDOA GROUP

ACTIVE COMPARATOR

ELDOA position was instructed to this group

Other: ELDOA

CONVENTIONAL PHYSIOTHERAPY

EXPERIMENTAL

Hot pack,TENS and mobalization was given in this group

Other: CONVENTIONAL PHYSIOTHERAPY

Interventions

ELDOAOTHER

For Spinal Segment L4-L5 and L5-S1 proper ELDOA position was instructed to the experiment group patients.ELDOA stands for Elongation Longitudinaux Avec Decoaption Osteo Articulaire, or LOADS (Longitudinal Osteo-articular De-coaptation Stretching). ... They can be described as fascial stretch that localizes tension at the level of a specific spinal segmental.

ELDOA GROUP
CONVENTIONAL PHYSIOTHERAPYOTHER

Transcutaneous Electrical Nerve Stimulation (TENS): 120Z dual channel TENS unit made in Japan was used in the research. Electrodes of TENS were placed on lumbar region and TENS was given for 15 minutes on Constant mode. Intensity was adjusted according to patient's comfort. Hot pack was applied on the lumbar region for 10 - 15 minutes.Lumbar Mobilization (CPA) was given on spinous process of L1- L5 vertebrae and L5-S1. For every session given 3 sets of 10 repetitions of each lumbar vertebra was performed.

CONVENTIONAL PHYSIOTHERAPY

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radicular pain radiates into the lower extremity
  • Positive response of at least 4 of the following test
  • SLR test
  • Limited ROM
  • Valsalva maneuver
  • Lumbar Compression Test
  • Deep tendon reflexes (knee and ankle jerk).

You may not qualify if:

  • Inflammatory Arthritis, Mass occupied lesion, Fracture, piriformis syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aqua research Center

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (9)

  • Kelsey JL. An epidemiological study of the relationship between occupations and acute herniated lumbar intervertebral discs. Int J Epidemiol. 1975 Sep;4(3):197-205. doi: 10.1093/ije/4.3.197.

    PMID: 1184269BACKGROUND

  • O'Sullivan MG, Connolly AE, Buckley TF. Recurrent lumbar disc protrusion. Br J Neurosurg. 1990;4(4):319-25. doi: 10.3109/02688699008992741.

    PMID: 2222878BACKGROUND

  • Pynsent FJ. Oswestry Low Back Pain Disability Questionnaire 1980 [cited 2016 2 August]; Available from: http://www.rehab.msu.edu/_files/_docs/Oswestry_Low_Back_Disability.pdf.

    BACKGROUND

  • Haegg O. Oswestry Disability Index. Encyclopedia of Pain: Springer; 2013. p. 2559-62.

    BACKGROUND

  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PMID: 22588748BACKGROUND

  • Hammer WI. Functional soft-tissue examination and treatment by manual methods: Jones & Bartlett Learning; 2007.

    BACKGROUND

  • Morre N, Planat C. Sur trois granites des sondages de Marchenoir, Boissy-sur-Saint-Yon et Courgent de la partie occidentale du bassin de Paris. Bulletin de la Sociéte geologique de France. 1964;5(3):358-62.

    BACKGROUND

  • McCarroll JR, Miller JM, Ritter MA. Lumbar spondylolysis and spondylolisthesis in college football players. A prospective study. Am J Sports Med. 1986 Sep-Oct;14(5):404-6. doi: 10.1177/036354658601400513.

    PMID: 3777317BACKGROUND

  • Lee RY, Evans JH. Loads in the lumbar spine during traction therapy. Aust J Physiother. 2001;47(2):102-8. doi: 10.1016/s0004-9514(14)60301-9.

    PMID: 11552865BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Abdul Ghafoor Sajjad,, PHD*

    Shifa Tameer e milat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 23, 2020

Study Start

August 27, 2017

Primary Completion

February 10, 2021

Study Completion

February 15, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)