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

Sponsors

Lead Sponsor: Western Galilee Hospital-Nahariya

Source 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.

Overall Status Withdrawn
Start Date 2010-12-31
Completion Date 2019-06-01
Primary Completion Date 2019-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
pain scores on visual analog scale visual analog scale will be mesuered before and one hour following every pain medication delivery
Secondary Outcome
Measure Time Frame
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
Condition
Intervention

Intervention Type: Drug

Intervention Name: Diclofenac hydroxyethylpyrrolidine

Description: IM/PO

Other Name: Voltaren, Abitren

Intervention Type: Drug

Intervention Name: orphenadrine

Description: IM/PO orphenadrine

Other Name: Flexin

Intervention Type: Drug

Intervention Name: Tramadol

Description: IM/PO tramadol

Other Name: Tramadex, Tramal

Intervention Type: Drug

Intervention Name: Dipyrone

Description: PO/IM Dipyrone

Other Name: Optalgin, Phanalgin

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

15 Years

Maximum Age:

100 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Nimrod Rahamimov, M.D. Principal Investigator Western Galilee Hospital
Verification Date

2020-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Western Galilee Hospital-Nahariya

Investigator Full Name: Nimrod Rahamimov

Investigator Title: Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: IMmed

Type: Active Comparator

Description: Patients receiving intra-muscular medication and oral placebo

Label: POmed

Type: Active Comparator

Description: Patients receiving intra-muscular placebo and oral medication

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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