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

Not Applicable

Withdrawn

• Conditions: Pain Relief
• Interventions: Drug: Diclofenac hydroxyethylpyrrolidine; Drug: orphenadrine; Drug: Tramadol; Drug: Dipyrone

• Registration Number: NCT01263652
• Lead Sponsor: Western Galilee Hospital-Nahariya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-21
• Study Start: 2010-12-31
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with chronic and acute back pain

Exclusion Criteria

• Recent Spine Surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POmed	Tramadol	Patients receiving intra-muscular placebo and oral medication
IMmed	Dipyrone	Patients receiving intra-muscular medication and oral placebo
POmed	Diclofenac hydroxyethylpyrrolidine	Patients receiving intra-muscular placebo and oral medication
IMmed	Tramadol	Patients receiving intra-muscular medication and oral placebo
POmed	Dipyrone	Patients receiving intra-muscular placebo and oral medication
IMmed	Diclofenac hydroxyethylpyrrolidine	Patients receiving intra-muscular medication and oral placebo
IMmed	orphenadrine	Patients receiving intra-muscular medication and oral placebo
POmed	orphenadrine	Patients receiving intra-muscular placebo and oral medication

Primary Outcome Measures

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

Secondary Outcome Measures

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