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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics, Non-Narcotic
Diclofenac hydroxyethylpyrrolidine
Diclofenac
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
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

ClinicalTrials.gov processed this record on September 30, 2014