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.

Study Overview

• Status: Withdrawn
• Conditions: Pain Relief
• Intervention / Treatment: Drug: Diclofenac hydroxyethylpyrrolidine; Drug: orphenadrine; Drug: Tramadol; Drug: Dipyrone

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic and acute back pain

Exclusion Criteria:

• Recent Spine Surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IMmed; Patients receiving intra-muscular medication and oral placebo	Drug: Diclofenac hydroxyethylpyrrolidine; IM/PO; Other Names: Voltaren, Abitren; Drug: orphenadrine; IM/PO orphenadrine; Other Names: Flexin; Drug: Tramadol; IM/PO tramadol; Other Names: Tramadex, Tramal; Drug: Dipyrone; PO/IM Dipyrone; Other Names: Optalgin, Phanalgin
Active Comparator: POmed; Patients receiving intra-muscular placebo and oral medication	Drug: Diclofenac hydroxyethylpyrrolidine; IM/PO; Other Names: Voltaren, Abitren; Drug: orphenadrine; IM/PO orphenadrine; Other Names: Flexin; Drug: Tramadol; IM/PO tramadol; Other Names: Tramadex, Tramal; Drug: Dipyrone; PO/IM Dipyrone; Other Names: Optalgin, Phanalgin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scores on visual analog scale	up to 7 days for each patient per hospitalization	visual analog scale will be mesuered before and one hour following every pain medication delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Questionnaire assessing pain and pain relief	A questionnaire will be filled immediately before and one hour following analgesic administration	Before administaration of pain control medication and one hour following analgesic administration
patient preference Questionnaire	every patient will be asked for his prefered analgesic delivery method	before first analgesic administration at the current hositalization

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Nimrod Rahamimov, M.D., Western Galilee Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2010
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (Estimate): December 21, 2010

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pain; oral; spine; intramuscular; preference
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Cytochrome P-450 Enzyme Inhibitors; Neuromuscular Agents; Muscle Relaxants, Central; Antiparkinson Agents; Anti-Dyskinesia Agents; Cytochrome P-450 CYP2B6 Inhibitors; Diclofenac; Tramadol; Orphenadrine; Dipyrone; Diclofenac hydroxyethylpyrrolidine
• Other Study ID Numbers: SpinePainIMPO