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Lumbar Disc HerniationNCT02699164

Remission of Lumbar Disc Herniation by Physiotherapy

A study testing DRX 9000, Axiom Worldwide, Tampa, Florida, physiotherapy and spinal stabilization exercise in people with Lumbar Disc Herniation, run by Hacettepe University.

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 study was conducted with the aim of determining whether or not Non surgical spinal decompression therapy was effective in remission of herniation, decreasing pain and improving functional status. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
DRX 9000, Axiom Worldwide, Tampa, Florida, physiotherapy and spinal stabilization exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jan 2014to Jun 2015
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 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • diagnosed as lumbar disc herniation suffering from low back pain at least 8 weeks

Who cannot join

  • undergone any spinal surgery clinical diagnosis of osteoporosis clinical diagnosis of scoliosis and spondylolisthesis any neurological disease causes sensorial loss

About this study

Official title: Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması

This study was conducted with the aim of determining whether or not Non surgical spinal decompression therapy was effective in remission of herniation, decreasing pain and improving functional status.

Read the detailed description

Both groups received combination of electrotherapy, deep friction massage and stabilization exercise for fifteen session.

Combine group received non surgical spinal decompression therapy (NSDT) different from conventional physiotherapy group. Numeric Analog Scale, Straight leg raise (SLR) test, Oswestry Disability Index (ODI) were applied at baseline and after treatment. Disc height and herniation thickness were measured on Magnetic Resonance Imagination (MRI) which performed at baseline and three months after therapy.

Being tested
DRX 9000, Axiom Worldwide, Tampa, Florida, physiotherapy, spinal stabilization exercise
Keywords
non surgical spinal decompression therapy, deep friction massage, exercise
Medical subject headings
Intervertebral Disc Displacement, Motor Activity

What participants receive

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

  • DRX 9000, Axiom Worldwide, Tampa, FloridaDevice

    non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).

  • physiotherapyOther

    electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

  • spinal stabilization exerciseOther

    spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

Study groups in NCT02699164
Study groupRoleWhat they receive
combine groupExperimentalConventional physiotherapy applied 15 sessions of treatment. In addition to conventional physiotherapy non-surgical spinal decompression therapy applied. First 10 sessions of treatment non-surgical decompression therapy applied and last 5 sessions spinal stabilization exercise applied.
Receives: Device: DRX 9000, Axiom Worldwide, Tampa, Florida; Other: physiotherapy; Other: spinal stabilization exercise
conventional physiotherapyExperimentalconventional physiotherapy applied 15 sessions of treatment. Conventional physiotherapy consisted hotpack, Transcutaneal Electric Nerve Stimulation(TENS) and Ultrasound Currents. Spinal stabilization exercises applied last five sessions of therapy.
Receives: Other: physiotherapy; Other: spinal stabilization exercise

What is being measured

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

  1. herniation thickness

    herniation thickness were measured on MRI.

    Measured: change from baseline in herniation thickness and disc height at three months

Secondary outcomes (3)

  1. function

    Oswestry Disability Index was used.Oswestry Disability Index used to assess the changes in function and disability levels. Scores range from 0 to 100.

    scores between 0 and 20 described as "minimal disability", scores between 21and 40 described as "moderate disability",scores between 41and 60 described as "severe disability",scores between 61 and 80 described as "crippled" and scores between 81 and 100 described as " bed bounded"

    Measured: up to 3 months

  2. mobility

    straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.

    Measured: up to 3 months

  3. pain severity

    numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".

    Measured: change form baseline in pain severity at 15 sessions of treatment

Timeline

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

  1. First posted4 Mar 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699164
Sponsor's protocol ID
GO14-265
Status last verified
Aug 2016
First submitted
25 Feb 2016
Last updated
16 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lundon K, Bolton K. Structure and function of the lumbar intervertebral disk in health, aging, and pathologic conditions. J Orthop Sports Phys Ther. 2001 Jun;31(6):291-303; discussion 304-6. doi: 10.2519/jospt.2001.31.6.291.

    PubMed 11411624

  • Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155. doi: 10.1186/1471-2474-11-155.

    PubMed 20615252

  • Schoenfeld AJ, Weiner BK. Treatment of lumbar disc herniation: Evidence-based practice. Int J Gen Med. 2010 Jul 21;3:209-14. doi: 10.2147/ijgm.s12270.

    PubMed 20689695

  • Lurie JD, Tosteson AN, Tosteson TD, Carragee E, Carrino JA, Kaiser J, Sequeiros RT, Lecomte AR, Grove MR, Blood EA, Pearson LH, Herzog R, Weinstein JN. Reliability of magnetic resonance imaging readings for lumbar disc herniation in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Apr 20;33(9):991-8. doi: 10.1097/BRS.0b013e31816c8379.

    PubMed 18427321

  • Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.

    PubMed 17119140

  • Romanowski M, Romanowska J, Grzeskowiak M. A comparison of the effects of deep tissue massage and therapeutic massage on chronic low back pain. Stud Health Technol Inform. 2012;176:411-4.

    PubMed 22744541

  • Hahne AJ, Ford JJ, Hinman RS, Taylor NF, Surkitt LD, Walters AG, McMeeken JM. Outcomes and adverse events from physiotherapy functional restoration for lumbar disc herniation with associated radiculopathy. Disabil Rehabil. 2011;33(17-18):1537-47. doi: 10.3109/09638288.2010.533814. Epub 2010 Nov 20.

    PubMed 21091049

  • Choi J, Lee S, Hwangbo G. Influences of spinal decompression therapy and general traction therapy on the pain, disability, and straight leg raising of patients with intervertebral disc herniation. J Phys Ther Sci. 2015 Feb;27(2):481-3. doi: 10.1589/jpts.27.481. Epub 2015 Feb 17.

    PubMed 25729196

Questions about this trial

What is this clinical trial studying?

A study testing DRX 9000, Axiom Worldwide, Tampa, Florida, physiotherapy and spinal stabilization exercise in people with Lumbar Disc Herniation, run by Hacettepe University.

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 1 inclusion and 1 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 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

herniation thickness (time frame: change from baseline in herniation thickness and disc height at three months). 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 NCT02699164, which also lists 8 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 16 Aug 2016.

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