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

Study Overview
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Brief Summary
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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.

Official Title
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The Relationship Between Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

Conditions
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Pain Relief

Intervention / Treatment
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* Drug: Diclofenac hydroxyethylpyrrolidine
* Drug: orphenadrine
* Drug: Tramadol
* Drug: Dipyrone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic and acute back pain Exclusion Criteria: Recent Spine Surgery

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, intramuscular, oral, spine, preference