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

This study is not yet open for participant recruitment.
Verified November 2010 by Western Galilee Hospital-Nahariya
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
History of Changes
  Purpose

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.


Condition Intervention
Pain Relief
 Drug: Diclofenac hydroxyethylpyrrolidine
Drug: orphenadrine
Drug: Tramadol
Drug: Dipyrone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Relationship Between Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IMmed
Patients receiving intra-muscular medication and oral placebo
 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: POmed
Patients receiving intra-muscular placebo and oral medication
 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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic and acute back pain

Exclusion Criteria:

  • Recent Spine Surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263652

Locations
Israel
Western Galilee Hospital Not yet recruiting
Naharia, Israel
Contact: Adi H Shani, R.N. , BA     +97249107200     a_eilat@walla.com    
Contact: Nimrod Rahamimov, M.D.     +972507887564     nimrod.rahamimov@naharia.health.gov.il    
Principal Investigator: Nimrod Rahamimov, M.D.            
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Nimrod Rahamimov, M.D. Western Galilee Hospital
  More Information

No publications provided

Responsible Party: Dr. N.Rahamimov, M.D., Western Galilee Hospital
ClinicalTrials.gov Identifier: NCT01263652     History of Changes
Other Study ID Numbers: SpinePainIMPO
Study First Received: October 6, 2010
Last Updated: December 16, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:
Pain
intramuscular
oral
spine
preference

Additional relevant MeSH terms:
Analgesics
Diclofenac
Dipyrone
Tramadol
Diclofenac hydroxyethylpyrrolidine
Orphenadrine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
 Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Narcotics

ClinicalTrials.gov processed this record on May 21, 2013