Orphenadrine and Methocarbamol for LBP

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02665286
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 3
• Actual Duration (Months): 14
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: Orphenadrine; Drug: Methocarbamol; Drug: Naproxen; Drug: Placebo	Phase 4

Detailed Description

Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Naproxen 500mg tablets taken twice per day + placebo. Placebo dose will be either 1 capsule orally twice per day or 1 or 2 capsules orally, thrice per day Naproxen 500mg po BID x 10 days #20 + Placebo	Drug: Naproxen; Naproxen 500mg PO BID x 7 days; Other Names: nonsteroidal anti-inflammatory drug ; Drug: Placebo; 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
Active Comparator: Orphenadrine Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine	Drug: Orphenadrine; Orphenadrine 100mg PO BID x 7 days; Other Names: anticholinergic drug ; Drug: Naproxen; Naproxen 500mg PO BID x 7 days; Other Names: nonsteroidal anti-inflammatory drug
Active Comparator: Methocarbamol Naproxen 500mg tablets, orally twice per day + methocarbamol 750mg, orally as 1 or 2 tabs, thrice per day Naproxen 500mg po BID x 10 days #20 + Methocarbamol	Drug: Methocarbamol; Methocarbamol 750mg 1-2 tabs po TID x 7 days; Other Names: Muscle relaxant ; Drug: Naproxen; Naproxen 500mg PO BID x 7 days; Other Names: nonsteroidal anti-inflammatory drug

Outcome Measures

Primary Outcome Measures

1. Functional Impairment as Measured on the Roland Morris Disability Questionnaire [1 week]

   Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.

Secondary Outcome Measures

1. Cases of Moderate or Severe LBP [1 week]

   Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none

2. Medications--Patient Self Report of Medication Use [1 week]

   Participants still using medication such as analgesics for LBP after treatment

3. Patient Satisfaction With Treatment [1 week]

   The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• LBP duration <= 2 weeks

• No trauma to low back within previous month

• No radicular symptoms

• No history of low back pain or history of only infrequent episodes

Exclusion Criteria:

• Medication allergies or contra-indications

• Not available for follow-up

• Chronic pain syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 27, 2016

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Associate Professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02665286
• Other Study ID Numbers: 2015-5903
• First Posted: Jan 27, 2016
• Last Update Posted: Jun 26, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Orphenadrine; Methocarbamol; Cholinergic Antagonists

Study Results

Participant Flow

Arm/Group Title	Placebo	Orphenadrine	Methocarbamol
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Period Title: Overall Study
STARTED	79	80	81
COMPLETED	76	78	80
NOT COMPLETED	3	2	1

Baseline Characteristics

Arm/Group Title	Placebo	Orphenadrine	Methocarbamol	Total
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Total of all reporting groups
Overall Participants	79	80	81	240
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (12)	40 (12)	38 (12)	39 (12)
Sex: Female, Male (Count of Participants)
Female	34 43%	34 42.5%	41 50.6%	109 45.4%
Male	45 57%	46 57.5%	40 49.4%	131 54.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	79 100%	80 100%	81 100%	240 100%
Duration of Back Pain Prior to Study (Hours) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Hours]	48	72	48	48

Outcome Measures

1. Primary Outcome

Title	Functional Impairment as Measured on the Roland Morris Disability Questionnaire
Description	Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Orphenadrine	Methocarbamol
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Measure Participants	76	78	80
Mean (95% Confidence Interval) [units on a scale]	10.9	9.4	8.1

2. Secondary Outcome

Title	Cases of Moderate or Severe LBP
Description	Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Orphenadrine	Methocarbamol
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Measure Participants	76	78	80
Count of Participants [Participants]	34 43%	26 32.5%	31 38.3%

3. Secondary Outcome

Title	Medications--Patient Self Report of Medication Use
Description	Participants still using medication such as analgesics for LBP after treatment
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Orphenadrine	Methocarbamol
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Measure Participants	76	78	80
Count of Participants [Participants]	42 53.2%	40 50%	50 61.7%

4. Secondary Outcome

Title	Patient Satisfaction With Treatment
Description	The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Orphenadrine	Methocarbamol
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days	Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
Measure Participants	75	78	78
Count of Participants [Participants]	51 64.6%	53 66.3%	51 63%

Adverse Events

Time Frame	1 week after treatment
Arm/Group Title	Placebo		Orphenadrine		Methocarbamol
Arm/Group Description	Naproxen 500mg po BID x 10 days #20 + Placebo Naproxen: Naproxen 500mg PO BID x 7 days Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days		Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine: Orphenadrine 100mg PO BID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days		Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days Naproxen: Naproxen 500mg PO BID x 7 days
All Cause Mortality
	Placebo		Orphenadrine		Methocarbamol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/78 (0%)		0/80 (0%)
Serious Adverse Events
	Placebo		Orphenadrine		Methocarbamol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/78 (0%)		0/80 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Orphenadrine		Methocarbamol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/76 (11.8%)		8/78 (10.3%)		14/80 (17.5%)
Gastrointestinal disorders
Stomach irritation	1/76 (1.3%)	1	1/78 (1.3%)	1	4/80 (5%)	4
Nausea	1/76 (1.3%)	1	0/78 (0%)	0	3/80 (3.8%)	3
Nervous system disorders
Drowsy	5/76 (6.6%)	5	8/78 (10.3%)	8	13/80 (16.3%)	13
dizz	2/76 (2.6%)	2	3/78 (3.8%)	3	4/80 (5%)	4

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.