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Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Western Galilee Hospital-Nahariya.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01263652
First received: October 6, 2010
Last updated: December 16, 2010
Last verified: November 2010

October 6, 2010
December 16, 2010
December 2010
December 2011   (final data collection date for primary outcome measure)
pain scores on visual analog scale [ Time Frame: visual analog scale will be mesuered before and one hour following every pain medication delivery ] [ Designated as safety issue: No ]
up to 7 days for each patient per hospitalization
Same as current
Complete list of historical versions of study NCT01263652 on ClinicalTrials.gov Archive Site
  • Patient Questionnaire assessing pain and pain relief [ Time Frame: Before administaration of pain control medication and one hour following analgesic administration ] [ Designated as safety issue: No ]
    A questionnaire will be filled immediately before and one hour following analgesic administration
  • patient preference Questionnaire [ Time Frame: before first analgesic administration at the current hositalization ] [ Designated as safety issue: No ]
    every patient will be asked for his prefered analgesic delivery method
Same as current
Not Provided
Not Provided
 
Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
The Relationship Between Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients.

The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain Relief
  • Drug: Diclofenac hydroxyethylpyrrolidine
    IM/PO
    Other Name: Voltaren, Abitren
  • Drug: orphenadrine
    IM/PO orphenadrine
    Other Name: Flexin
  • Drug: Tramadol
    IM/PO tramadol
    Other Name: Tramadex, Tramal
  • Drug: Dipyrone
    PO/IM Dipyrone
    Other Name: Optalgin, Phanalgin
  • Active Comparator: IMmed
    Patients receiving intra-muscular medication and oral placebo
    Interventions:
    • Drug: Diclofenac hydroxyethylpyrrolidine
    • Drug: orphenadrine
    • Drug: Tramadol
    • Drug: Dipyrone
  • Active Comparator: POmed
    Patients receiving intra-muscular placebo and oral medication
    Interventions:
    • Drug: Diclofenac hydroxyethylpyrrolidine
    • Drug: orphenadrine
    • Drug: Tramadol
    • Drug: Dipyrone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
December 2013
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with chronic and acute back pain

Exclusion Criteria:

  • Recent Spine Surgery
Both
15 Years and older
No
Israel
 
NCT01263652
SpinePainIMPO
No
Dr. N.Rahamimov, M.D., Western Galilee Hospital
Western Galilee Hospital-Nahariya
Not Provided
Principal Investigator: Nimrod Rahamimov, M.D. Western Galilee Hospital
Western Galilee Hospital-Nahariya
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP