Trial document





This trial has been registered retrospectively.
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  DRKS00010011

Trial Description

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Title

Does therapist’s attitude affect clinical outcome of lumbar facet joint injections?

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The study examines if the doctor´s attitude affects the results of CT-guided pain therapy of the small intervertebral lumbar joints.
All patients will be divided into two groups. Both groups will receive the same therapeutic procedure. The only difference between both groups regards the postprocedural management. One group will have a post-therapeutic conversation and will be demonstrated four standard CT images of the therapy, the second group will pass without any further contact after the therapy. Pain of all patients will be assessed at different time points after the therapy.

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Brief Summary in Scientific Language

The study investigates how the therapist´s attitude affect the clinical outcome of intra-articular lumbar facet joint injections.
All enrolled patients will be divided into two groups and will receive the same standard CT-guided intra-articular facet joint injection. The only difference between both groups regards the post-procedural patient management. The patients of the experimetal group will hold a post-procedural conversation and is shown four standard CT images of the performed therapy. The control group will not have any further contact after the therapy. Outcome will be assessed with a pain-based verbal numeric scale at different time point after treatment. We hypothesize that the the clinical outcome will be better in the experimental group due to hetero-suggestive effect oth the therapist.

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Organizational Data

  •   DRKS00010011
  •   2016/02/10
  •   [---]*
  •   yes
  •   Approved
  •   FF 141/2014, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   M54.5 -  Low back pain
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Interventions/Observational Groups

  •   Experimental group: Routine CT-guided lumbar facet joint injection and a post-procedural conversation with the physician. This includes the demonstration of four standard CT images of the performed therapy.
  •   Control group: Routine CT-guided lumbar facet joint injection without a post-procedural conversation.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Therapy effect after 6 months (pain documented by the verbal numeric scale)

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Secondary Outcome

Pain assessment after 1 week, 1 month, and 3 months with the verbal numeric scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/04/17
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Chronic low back pain, MRI proven lumbar facet joint degeneration, age > 18 years

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Exclusion Criteria

Prior surgery on the lumbar spine, prior lumbar facet joint intra-articular injections in the last 12 months, vertebral fractures or stenosis of the lumbar spinal canal, poorly regulated diabetes, known allergy to bupivacaine or triamcinolone acetate

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, IDIR,
    • Mr.  Dr. med.  Adel  Maataoui 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, IDIR,
    • Mr.  Dr. med.  Adel  Maataoui 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, IDIR,
    • Mr.  Dr. med.  Adel  Maataoui 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, IDIR,
    • Mr.  Dr. med.  Adel  Maataoui 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.