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

• Sponsor: Stony Brook University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00790270
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Strain	Drug: Cyclobenzaprine; Drug: Ibuprofen; Drug: Ibuprofen plus Cyclobenzaprine	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Jan 1, 2004
• Actual Study Completion Date: Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cyclobenzaprine	Drug: Cyclobenzaprine; 5 mg orally every 8 hours as needed; Other Names: flexeril
Active Comparator: Ibuprofen	Drug: Ibuprofen; Ibuprofen 400 mg every 8 hours as needed; Other Names: motrin, advil
Experimental: Ibuprophen plus Cyclobenzaprine	Drug: Ibuprofen plus Cyclobenzaprine; Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed; Other Names: motrin or advil with flexeril

Outcome Measures

Primary Outcome Measures

1. Pain [Daily for 1 week]

2. Use of Rescue Medications [24 hours]

   the number of patients taking additional rescue medications beyond the study meds

Secondary Outcome Measures

1. Time to Resumption of Work [1 week]

2. Resumption of Work or School [next day]

   number of patients resuming regular activity the day following enrollment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• neck pain within 24 hours of injury

Exclusion Criteria:

• Children, allergy or contraindication to any of the study drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook University	Stony Brook	New York	United States	11733

Sponsors and Collaborators

• Stony Brook University

Investigators

• Principal Investigator: adam singer, md, Stony Brook University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00790270
• Other Study ID Numbers: SB2003-1234
• First Posted: Nov 13, 2008
• Last Update Posted: Nov 21, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by , ,: Cervical strain; whiplash; ibuprofen; cyclobenzaprine
• Additional relevant MeSH terms: Sprains and Strains; Ibuprofen; Amitriptyline; Cyclobenzaprine

Study Results

Participant Flow

Arm/Group Title	Cyclobenzaprine	Ibuprofen	Ibuprophen Plus Cyclobenzaprine
Arm/Group Description
Period Title: Overall Study
STARTED	21	20	20
COMPLETED	21	20	20
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Cyclobenzaprine	Ibuprofen	Ibuprophen Plus Cyclobenzaprine	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	20	20	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	21 100%	20 100%	20 100%	61 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36 (13)	32 (10)	32 (10)	33 (13)
Sex: Female, Male (Count of Participants)
Female	14 66.7%	11 55%	9 45%	34 55.7%
Male	7 33.3%	9 45%	11 55%	27 44.3%
Region of Enrollment (participants) [Number]
United States	21 100%	20 100%	20 100%	61 100%

Outcome Measures

1. Primary Outcome

Title	Pain
Time Frame	Daily for 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Secondary Outcome

Title	Time to Resumption of Work
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

Title	Use of Rescue Medications
Description	the number of patients taking additional rescue medications beyond the study meds
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

number of patients using additionl anlagesics on the day following enrollment

Arm/Group Title	Cyclobenzaprine	Ibuprofen	Ibuprophen Plus Cyclobenzaprine
Arm/Group Description
Measure Participants	21	20	20
Number [participants]	13 61.9%	9 45%	9 45%

4. Secondary Outcome

Title	Resumption of Work or School
Description	number of patients resuming regular activity the day following enrollment.
Time Frame	next day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cyclobenzaprine	Ibuprofen	Ibuprophen Plus Cyclobenzaprine
Arm/Group Description
Measure Participants	21	20	20
Number [participants]	8 38.1%	14 70%	13 65%

Adverse Events

Time Frame	next day
Adverse Event Reporting Description	th number of patients reporting an adverse event on the day following enrollment and each additional day for 1 week.
Arm/Group Title	Cyclobenzaprine		Ibuprofen		Ibuprophen Plus Cyclobenzaprine
Arm/Group Description
All Cause Mortality
	Cyclobenzaprine		Ibuprofen		Ibuprophen Plus Cyclobenzaprine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cyclobenzaprine		Ibuprofen		Ibuprophen Plus Cyclobenzaprine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Cyclobenzaprine		Ibuprofen		Ibuprophen Plus Cyclobenzaprine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.