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

NCT01263652 | Withdrawn

• 1 other identifier: SpinePainIMPO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain Relief

Keywords

Pain; intramuscular; oral; spine; preference

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Questionnaire assessing pain and pain relief

  Before administaration of pain control medication and one hour following analgesic administration

• patient preference Questionnaire

  before first analgesic administration at the current hositalization

Study Arms (2)

IMmed

ACTIVE COMPARATOR

Patients receiving intra-muscular medication and oral placebo

Drug: Diclofenac hydroxyethylpyrrolidine; Drug: orphenadrine; Drug: Tramadol; Drug: Dipyrone

POmed

ACTIVE COMPARATOR

Patients receiving intra-muscular placebo and oral medication

Drug: Diclofenac hydroxyethylpyrrolidine; Drug: orphenadrine; Drug: Tramadol; Drug: Dipyrone

Interventions

Diclofenac hydroxyethylpyrrolidine DRUG

IM/PO

Also known as: Voltaren, Abitren

IMmed; POmed

orphenadrine DRUG

IM/PO orphenadrine

Also known as: Flexin

IMmed; POmed

Tramadol DRUG

IM/PO tramadol

Also known as: Tramadex, Tramal

IMmed; POmed

Dipyrone DRUG

PO/IM Dipyrone

Also known as: Optalgin, Phanalgin

IMmed; POmed

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic and acute back pain

You may not qualify if:

• Recent Spine Surgery

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

MeSH Terms

Conditions

Pain

Interventions

diclofenac hydroxyethylpyrrolidine; Diclofenac; Orphenadrine; Indomethacin; Tramadol; Dipyrone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Nimrod Rahamimov, M.D.

  Western Galilee Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: December 21, 2010
• Study Start: December 31, 2010
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05