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

NCT ID: NCT01263652

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2019-06-01

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.

Detailed Description

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Conditions

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Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IMmed

Patients receiving intra-muscular medication and oral placebo

Group Type ACTIVE_COMPARATOR

Diclofenac hydroxyethylpyrrolidine

Intervention Type DRUG

IM/PO

orphenadrine

Intervention Type DRUG

IM/PO orphenadrine

Tramadol

Intervention Type DRUG

IM/PO tramadol

Dipyrone

Intervention Type DRUG

PO/IM Dipyrone

POmed

Patients receiving intra-muscular placebo and oral medication

Group Type ACTIVE_COMPARATOR

Diclofenac hydroxyethylpyrrolidine

Intervention Type DRUG

IM/PO

orphenadrine

Intervention Type DRUG

IM/PO orphenadrine

Tramadol

Intervention Type DRUG

IM/PO tramadol

Dipyrone

Intervention Type DRUG

PO/IM Dipyrone

Interventions

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Diclofenac hydroxyethylpyrrolidine

IM/PO

Intervention Type DRUG

orphenadrine

IM/PO orphenadrine

Intervention Type DRUG

Tramadol

IM/PO tramadol

Intervention Type DRUG

Dipyrone

PO/IM Dipyrone

Intervention Type DRUG

Other Intervention Names

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Voltaren, Abitren Flexin Tramadex, Tramal Optalgin, Phanalgin

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic and acute back pain

Exclusion Criteria

* Recent Spine Surgery
Minimum Eligible Age

15 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nimrod Rahamimov

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nimrod Rahamimov, M.D.

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital

Other Identifiers

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SpinePainIMPO

Identifier Type: -

Identifier Source: org_study_id

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