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Lumbar Disc HerniationNCT04860609

Compare the Effects of Decompression on Lumber Disc Protrusion Patient

A study testing Conventional Physiotherapy and Lumber Spinal Decompression in people with Lumbar Disc Herniation, run by Aqua Medical Services (Pvt) Ltd 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
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Trial summary

This is an RCT study in which 60 participant are included and half of the participant are randomized via lottery method in control and experimental group after fulfilling the inclusion criteria. The sampling technique is convenient sampling . Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Conventional Physiotherapy and Lumber Spinal Decompression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
21 Apr 2021to 25 Jun 2021
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • MRI of lumbar spine showing lumbar disc bulge
  • Localized and radiating pain more than 5 on NPRS

Who cannot join

  • Lumbar spondylolisthesis
  • Spinal stenosis
  • Fracture of lumbar spine
  • Spinal tumor
  • Ankylosing spondylitis
  • Patients taking blood thinner medication

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Abdul Ghaffor Sajjad

    Islamabad, Capital, 44000

Other trials in Pakistan

About this study

Official title: Compare the Effect of Spinal Decompression in Lumber Spine Disc Protrusion Patients

This is an RCT study in which 60 participant are included and half of the participant are randomized via lottery method in control and experimental group after fulfilling the inclusion criteria. The sampling technique is convenient sampling . The study compare the effects of conventional Physical Therapy and Decompression Therapy and determine the effectiveness of Decompression as treatment procedure for patients with Lumbar disc protrusion. The data collection procedure included the NPRS, ODI, structural questionnaire and assesment on the 1st, 4th and 8th visit. Data will be analyzed on IBM SPSS-21 {Statistical Procedure of Social Sciences} software. The assessment will be done on 1st, 4th and 8th visits. after checking the normality of the date the Parametric/Non Parametric test will be apply to compare the means of the these groups. The 95% confidence interval will be used in term OD p value 0.05

Read the detailed description

Low back pain is the common problem of our society, 80% people experience back pain at some stage of their life. Low Back pain life time prevalence is 65% to 80% and It is estimated that 28% experience disabling low back pain sometime during their lives.Point prevalence ranged from 12% to 33%, 1-year prevalence ranged from 22% to 65%, and lifetime prevalence ranged from 11% to 84%.Back pain peak prevalence age is 40-50, First episode of start in the 20's and recurrence rates between 39-71%. Women tend to be affected more in cervical spine problem then men and Men tend to more affected in lumbar spine problem than women. Majority (80-90%) of low back disorders occur at the L4/5 and/or L5/S1. The occupational risk factor include driving (P<0.001), lifting, carrying, pulling, pushing, and twisting (P<0.001 for all variables) as well as nondriving vibrational exposure (P<0.001).

Maitland divides lumber spine problems into two groups, in first group the L4/5 and L5/S1 intervertebral discs are frequently a source of symptoms and second group have postural, muscles balance, muscles weakness, muscles spasm degenerative changes and mechanical movement disorders problems. The L5-S1 Segment is the most common site of problem in the spine because this level bears more weight, Center of gravity passes directly through this vertebra, transition L5 Mobile and S1 Stable, Large angle B/w L5 \& S1 and great amount of movement.

The intervertebral disk makes up 1/3 of the total length of vertebral column. The disc contains 85% to 90% of water, but the amount decrease up to 65% with age. The water binding capacity of the disc decrease with age and degenerative changes begin to occur after 2nd decade of the life. The Facet joint carry 20-25% axial body load but this may reach 70% with degeneration of the Disc. The most significant biochemical change to occur in disc degeneration is loss of proteoglycan. This loss is responsible for a fall in the osmotic pressure of the disc matrix and therefore a loss of hydration. Loading may thus lead to inappropriate stress concentrations along the endplate or in the annulus.

Decompression therapy is a result oriented approach but it expensive and minimum availability in Pakistan. In physical therapy we use different exercise to solve the multiple spine problems. Some exercise used to treat orthopedic component such as mobilization, manipulation, SNAGS, and traction. Some exercise used to treat myogenic component such as Muscle energy technique, neuromuscular reeducation, active isolated stretch etc. Some exercise used to treat neurogenic component such as Neurodynamics, Active release technique etc. As we know the fascia is important component in our body most of the time the fascia restriction make the patient condition verse. Guy Voyer introduce the systems of exercise more the 35 years ago which works specially on spine at every intervertebral level including costal and pelvic articulation. These exercises are called Elongation Longitudinaux avec Decoaption Osteo-Articulaire (ELDOA) or simply Longitudinal Osteo-Articular De-coaptation Stretching (LOADS). It can be describe as fascial stretch that's localizes tension at the level of a specific spinal segment and create decompression. In which he combined improving the tone of the intrinsic muscles of the spine along with reinforcing the extrinsic muscles related to the spine aim the back and stretching the interlinking paraspinal muscles. ELDOA exercise is design for every level of the spine from base of the skull to sacro iliac joint. In each ELDOA exercise we create fascial tension above and below the joint or disc that one is trying to "open up" or decompress. The outcomes include; Release vertebral compression, improved blood circulation, Disc re-hydration, improve muscle tone and awareness. One of my study also proved that ELDOA Exercises improve the pain and functional level in the spinal disc protrusion patients.

Being tested
Conventional Physiotherapy, Lumber Spinal Decompression
Keywords
Decompression, Disc herniation, ODI, LBP
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.

  • Conventional PhysiotherapyOther

    The treatment will be given in the following way.

    1. Tens
    2. Infrared/Moist Heat heat for 10 minutes at low back region.
    3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
    4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
    5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
    6. Postural Education
    7. Home Plan
    8. Bed Rest with lumbar Sacral Support
    9. Home plan:

    Exercises Posture Correction Precautions Contra indication

  • Lumber Spinal DecompressionOther

    The treatment will be given in the following way.

    1. Tens
    2. Infrared/Moist Heat heat for 10 minutes at low back region.
    3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
    4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
    5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
    6. Postural Education
    7. Home Plan
    8. Decompression therapy session lumbar spinal decompression therapy for 30 minutes.
    9. Home plan:

    Exercises Posture Correction Precautions Contra indication

Study groups in NCT04860609
Study groupRoleWhat they receive
Conventional PhysiotherapyActive comparatorIt includes the pre-physiotherapy session by conventional physiotherapy
Receives: Other: Conventional Physiotherapy
Lumber spinal decompressionExperimentalIt includes the pre-physiotherapy session iby lumber spinal decompression along with conventional therapy.
Receives: Other: Lumber Spinal Decompression

What is being measured

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

  1. Numeric pain rating scale for back

    It is numeric pain rating scale for measuring pain intensity. it ranges from 0-10.In which 0 shows no pain,1-3 (mild pain),4-6(moderate pain) and 10 shows severe pain. As guided by the researcher, pain intensity was marked by the patient

    Measured: 8th weeks

  2. Flexion Range of Motion of lumber

    Double inclinometer is used

    Measured: 8th weeks

  3. SLR

    Single Inclinometer

    Measured: 8th weeks

  4. Side bending Lumber ROm

    Double inclinometer

    Measured: 8th week

  5. Extension Lumber ROM

    Double inclinometer is used

    Measured: 8th week

Timeline

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

  1. First posted27 Apr 2021
  2. Study start21 Apr 2021
  3. Primary completion21 Jun 2021
  4. Study completion25 Jun 2021

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
Model description
control group will recevie conventional physiotherapy sessions while the experimental group receive conventional along with decompression
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860609
Sponsor's protocol ID
Abdul Ghaffor 00501
Status last verified
Sep 2021
First submitted
21 Apr 2021
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • rchaeos Projects. (1999). Preliminary Site Report of the Oriental Institute of the University of Vienna and Archaeos: Excavation Project at Tell Arbid, Sector D Retrieved 04/09/2004, 2004, from http://www.archaeos.org/html/repor2js.htm

  • Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):927-35. doi: 10.1097/01.brs.0000158954.68522.2a.

    PubMed 15834338

  • Breslau, A. M., & Gabe, M. (1962). Ergebnisse der Polysaccharidhistochemie, Microorganismen, Invertebraten : mit 25. Stuttgart: Fischer.

  • Delauche-Cavallier MC, Budet C, Laredo JD, Debie B, Wybier M, Dorfmann H, Ballner I. Lumbar disc herniation. Computed tomography scan changes after conservative treatment of nerve root compression. Spine (Phila Pa 1976). 1992 Aug;17(8):927-33.

    PubMed 1387974

  • Dvorak J, Valach L, Fuhrimann P, Heim E. The outcome of surgery for lumbar disc herniation. II. A 4-17 years' follow-up with emphasis on psychosocial aspects. Spine (Phila Pa 1976). 1988 Dec;13(12):1423-7. doi: 10.1097/00007632-198812000-00016.

    PubMed 2975065

  • Frymoyer JW, Pope MH, Costanza MC, Rosen JC, Goggin JE, Wilder DG. Epidemiologic studies of low-back pain. Spine (Phila Pa 1976). 1980 Sep-Oct;5(5):419-23. doi: 10.1097/00007632-198009000-00005.

    PubMed 6450452

  • Hammer, W. I. (2007). Functional soft-tissue examination and treatment by manual methods: Jones & Bartlett Learning.

  • Khan, A. G. S. G. A., & Khan, A. (2016). Fascia Stretching Improve the Pain and Functional Level in Disc Protrusion Patients. Journal of Riphah College of Rehabilitaion Sciences, 4(1), 7-10.

  • Krause M, Refshauge KM, Dessen M, Boland R. Lumbar spine traction: evaluation of effects and recommended application for treatment. Man Ther. 2000 May;5(2):72-81. doi: 10.1054/math.2000.0235.

    PubMed 10903582

  • Magee, D. J. (2014). Orthopedic physical assessment: Elsevier Health Sciences. Maitland, G. D., Hengeveld, E., Banks, K., & English, K. (2005). Maitland's vertebral manipulation (Vol. 1): Butterworth-Heinemann.

  • Manchikanti L. Epidemiology of low back pain. Pain Physician. 2000 Apr;3(2):167-92.

    PubMed 16906196

  • Robin, M., & Stephen, M. The lumbar spine mechanical diagnosis & therapy, volume one and two. 2004: Spinal Publications, Nya Zeeland

  • van der Windt DA, Simons E, Riphagen II, Ammendolia C, Verhagen AP, Laslett M, Deville W, Deyo RA, Bouter LM, de Vet HC, Aertgeerts B. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007431. doi: 10.1002/14651858.CD007431.pub2.

    PubMed 20166095

  • Weber H. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine (Phila Pa 1976). 1983 Mar;8(2):131-40.

    PubMed 6857385

  • Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.

    PubMed 10872758

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Physiotherapy and Lumber Spinal Decompression in people with Lumbar Disc Herniation, run by Aqua Medical Services (Pvt) Ltd 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 2 inclusion and 6 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 5 Sep 2021. 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?

Numeric pain rating scale for back (time frame: 8th weeks). The study lists 5 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 NCT04860609, which also lists 15 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 5 Sep 2021.

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