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Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

NCT ID: NCT00790270

Last Updated: 2012-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-01-31

Brief Summary

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The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.

Detailed Description

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Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.

Conditions

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Cervical Strain

Keywords

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Cervical strain whiplash ibuprofen cyclobenzaprine

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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Cyclobenzaprine

Group Type ACTIVE_COMPARATOR

Cyclobenzaprine

Intervention Type DRUG

5 mg orally every 8 hours as needed

Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen 400 mg every 8 hours as needed

Ibuprophen plus Cyclobenzaprine

Group Type EXPERIMENTAL

Ibuprofen plus Cyclobenzaprine

Intervention Type DRUG

Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

Interventions

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Cyclobenzaprine

5 mg orally every 8 hours as needed

Intervention Type DRUG

Ibuprofen

Ibuprofen 400 mg every 8 hours as needed

Intervention Type DRUG

Ibuprofen plus Cyclobenzaprine

Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

Intervention Type DRUG

Other Intervention Names

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flexeril motrin, advil motrin or advil with flexeril

Eligibility Criteria

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Inclusion Criteria

* neck pain within 24 hours of injury

Exclusion Criteria

* Children, allergy or contraindication to any of the study drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Stony Brook University

Principal Investigators

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adam singer, md

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SB2003-1234

Identifier Type: -

Identifier Source: org_study_id