AzTrials
AzTrials

Lumbar Disc HerniationNCT04043611

Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion

A study testing Conservative physical therapy management and ELDOA in people with Lumbar Disc Herniation, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this randomized controlled trial will be to determine the effectiveness of ELDOA for treating lumbar disc protrusion. Two randomized groups of patients with lumbar disc protrusion will be treated with conservative physical therapy and the experimental group will be given ELDOA, in addition. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Conservative physical therapy management and ELDOA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 sitePakistan
Study dates
1 Mar 2019to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Limited ROM (hip/lumbar spine)
  • Pain more than 3 on NPRS
  • Pain ≥ 3 months

Who cannot join

  • Recurrent disc protrusion
  • Spondylolisthesis
  • Spondylosis
  • Malignancy
  • Infection
  • Trauma
  • Marked bony deformities

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Effect of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire Exercises in Lumbar Disc Protrusion

The aim of this randomized controlled trial will be to determine the effectiveness of ELDOA for treating lumbar disc protrusion. Two randomized groups of patients with lumbar disc protrusion will be treated with conservative physical therapy and the experimental group will be given ELDOA, in addition. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded

Read the detailed description

The study is aimed at determining the effects of ELDOA in treating disc protrusion at lumbar region and is being conducted in Max Rehab \& Physical Therapy Centre Islamabad and Pakistan Railway General Hospital, Rawalpindi (March 2019-June 2019). Sample size of the study is 34 with confidence interval of 95% and power of 0.8. 30 patients were screened and 29 were included in the study on the basis of inclusion criteria. Sealed envelope contained total 34 questionnaires, 17 for each group. Patients were allocated randomly on the basis of group mentioned on the Performa. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ELDOA Exercises in addition. Patients were examined at 1st visit before administration of any treatment and at 4th visit which was also the last one (after completing 4 sessions at alternate days). Baseline evaluation for demographics and symptomatology was taken. Self-reported questionnaire, ODI, NPRS, lumbar ROM and SLR were recorded at first and fourth visit for comparison. 26 patients completed the study while 1 patient from control group and 2 patients from experiment group were lost to follow up and were considered drop outs.

Being tested
Conservative physical therapy management, ELDOA
Keywords
Lumbar Disc Protrusion, ELDOA, Oswestry Disability Index
Medical subject headings
Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conservative physical therapy managementOther

    Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I \& II for pain, Grade III \& IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold), Hamstring, Piriformis McKenzie Prone Extension Exercises

  • ELDOAOther

    ELDOA positions (hold for 1 minute,4 alternate days a week) under supervision during session Conservative physical therapy management Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I \& II for pain, Grade III \& IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold),Hamstring,Piriformis

Study groups in NCT04043611
Study groupRoleWhat they receive
Conservative physical therapy managementActive comparatorTens and hot pack , Soft tissue mobilization , Maitland's Lumbar segmental mobilization, Traction, Neurodynamics, Active Stretching, McKenzie Prone Extension Exercises
Receives: Other: Conservative physical therapy management
ELDOAExperimentalConservative physical therapy management + ELDOA positions
Receives: Other: ELDOA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oswestry disability index

    Changes from the Baseline, Oswestry disability index (ODI) was developed in order to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). Scores from 0-20 to indicate "minimal disability," 20-40 to indicate "moderate disability," 40-60 to indicate "severe disability," 60-80 to indicate "housebound," and 80-100 to indicate "bedbound". The ODI score is recommended as a back pain-specific measure of disability.

    Measured: 4th day

  2. Numeric Pain rating scale

    Changes from the Baseline, Numeric Pain rating scale (NPRS) is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

    Measured: 4th day

  3. Range of Motion (ROM) Lumbar Spine (Flexion)

    Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer

    Measured: 4th day

  4. ROM Lumbar Spine (extension)

    ROM of Lumbar spine extension was taken with the help of inclinometer

    Measured: 4th day

  5. ROM Lumbar Spine (Right side flexion)

    ROM of Lumbar spine right side flexion was taken with the help of inclinometer

    Measured: 4th day

  6. ROM Lumbar Spine (left side Flexion)

    ROM of Lumbar spine left side flexion was taken with the help of inclinometer

    Measured: 4th day

  7. Straight Leg Raising (SLR)

    Straight Leg Raising range was taken with the help of inclinometer

    Measured: 4th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2019
  2. Study start1 Mar 2019
  3. Primary completion30 May 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04043611
Sponsor's protocol ID
RiphahIU Nida Rahim Malik
Status last verified
Aug 2019
First submitted
1 Aug 2019
Last updated
2 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vroomen PC, de Krom MC, Knottnerus JA. Predicting the outcome of sciatica at short-term follow-up. Br J Gen Pract. 2002 Feb;52(475):119-23.

    PubMed 11887877

  • Peul WC, van den Hout WB, Brand R, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial. BMJ. 2008 Jun 14;336(7657):1355-8. doi: 10.1136/bmj.a143. Epub 2008 May 23.

    PubMed 18502911

  • Tampier C, Drake JD, Callaghan JP, McGill SM. Progressive disc herniation: an investigation of the mechanism using radiologic, histochemical, and microscopic dissection techniques on a porcine model. Spine (Phila Pa 1976). 2007 Dec 1;32(25):2869-74. doi: 10.1097/BRS.0b013e31815b64f5.

    PubMed 18246010

  • Vroomen PC, de Krom MC, Wilmink JT, Kester AD, Knottnerus JA. Diagnostic value of history and physical examination in patients suspected of lumbosacral nerve root compression. J Neurol Neurosurg Psychiatry. 2002 May;72(5):630-4. doi: 10.1136/jnnp.72.5.630.

    PubMed 11971050

  • Fardon DF, Milette PC; Combined Task Forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology. Nomenclature and classification of lumbar disc pathology. Recommendations of the Combined task Forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology. Spine (Phila Pa 1976). 2001 Mar 1;26(5):E93-E113. doi: 10.1097/00007632-200103010-00006. No abstract available.

    PubMed 11242399

  • Kim SH, Kim HS, Kim SW. Lumbar disc herniation in tae kwon do athletic child. J Korean Neurosurg Soc. 2010 Dec;48(6):538-40. doi: 10.3340/jkns.2010.48.6.538. Epub 2010 Dec 31.

    PubMed 21430983

  • Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3.

    PubMed 20184717

  • Herzog W. The biomechanics of spinal manipulation. J Bodyw Mov Ther. 2010 Jul;14(3):280-6. doi: 10.1016/j.jbmt.2010.03.004.

    PubMed 20538226

  • Wegner I, Widyahening IS, van Tulder MW, Blomberg SE, de Vet HC, Bronfort G, Bouter LM, van der Heijden GJ. Traction for low-back pain with or without sciatica. Cochrane Database Syst Rev. 2013 Aug 19;2013(8):CD003010. doi: 10.1002/14651858.CD003010.pub5.

    PubMed 23959683

  • Coppieters MW, Andersen LS, Johansen R, Giskegjerde PK, Hoivik M, Vestre S, Nee RJ. Excursion of the Sciatic Nerve During Nerve Mobilization Exercises: An In Vivo Cross-sectional Study Using Dynamic Ultrasound Imaging. J Orthop Sports Phys Ther. 2015 Oct;45(10):731-7. doi: 10.2519/jospt.2015.5743. Epub 2015 Aug 24.

    PubMed 26304637

Questions about this trial

What is this clinical trial studying?

A study testing Conservative physical therapy management and ELDOA in people with Lumbar Disc Herniation, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry disability index (time frame: 4th day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04043611, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in