Low Back PainPhase 4NCT03068897

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

A Phase 4 study testing Metaxalone, Tizanidine and Baclofen in people with Low Back Pain, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Metaxalone, Tizanidine and Baclofen
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 320 participants
Where: 1 siteUnited States
Study dates: 3 May 2017to 11 Oct 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Present to ED primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in the elderly.
Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
Pain duration <2 weeks (336 hours). Patients with more than two weeks of pain are at increased risk of poor pain and functional outcomes.(9)

Show all 9Show fewer

Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month. Patients with more frequent back pain are at increased risk of poor pain and functional outcomes.(9)
Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Who cannot join

Not available for follow-up
Pregnant or breast-feeding
Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
Allergic to or intolerant of investigational medications
Contra-indications to non-steroidal anti-inflammatory drugs: 1) history of hypersensitivity to NSAIDs or aspirin 2) active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed 3) Severe heart failure (NYHA 2 or worse) 4) hypertension (JNC7 stage 2 or worse) 5) Chronic kidney disease 3 or worse 6) Current use of anti-coagulants 7) Hepatitis 8) Alcoholism
Contra-indications to muscle relaxants: 1) Concurrent use of centrally acting opioids; 2) Renal impairment; 3) Liver abnormality including cirrhosis or elevated enzymes 4) Use of any of the following medications: fluvoxamine, fluoroquinolones, amiodarone, mexiletine, propafenone, verapamil, cimetidine, famotidine, acyclovir, ticlopidine, oral contraceptive pills

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial

Conditions: Low Back Pain
Being tested: Metaxalone, Tizanidine, Baclofen, Ibuprofen 600 mg, Educational intervention
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetaxaloneDrug
Metaxalone 400-800mg
TizanidineDrug
Tizanidine 2-4mg
BaclofenDrug
Baclofen 10-20mg
Ibuprofen 600 mgDrug
Ibuprofen
Educational interventionBehavioural
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.

Study groups in NCT03068897
Study group	Role	What they receive
Metaxalone	Active comparator	Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Receives: Drug: Metaxalone; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention
Tizanidine	Active comparator	Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Receives: Drug: Tizanidine; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention
Baclofen	Active comparator	Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Receives: Drug: Baclofen; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention
Placebo	Placebo comparator	Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention. Receives: Drug: Ibuprofen 600 mg; Behavioral: Educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.
Measured: Baseline and 7 days

Secondary outcomes (3)

Number of Participants Who Experience Change in Low Back Pain
Change is assessed by verbal numerical scale of which 0 represents no pain and 10 represents the worst pain imaginable between the baseline ED visit and the one week follow-up (baseline - 1 week ). The baseline questions will refer to the time period immediately prior to ED presentation (Before you came to the ER today, were you able to…..)
Measured: Baseline and 7 days
Number of Participants With Need for Medication for Low Back Pain
Patients will be asked what medications they have used for low back pain
Measured: 7 days
Levels of Disability
Disability will be assessed with the Roland-Morris Disability Questionnaire (RMDQ) where patients are asked to tick a box if they agree with 24 statements regarding their ability to perform certain activities (dressing, housework, walking). If the don't agree with the statement (able to perform those activities) they need to leave the tick-box blank or unchecked. Every agreement (tick) counts as a point and an absolute value is formed (min: 0, max: 24). The higher the value the higher the disability level.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 201711 Oct 2018

First posted3 Mar 2017
Study start3 May 2017
Primary completion11 Jul 2018
Study completion11 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03068897
Sponsor's protocol ID: 2017-7566
Status last verified: Aug 2020
First submitted: 16 Feb 2017
Last updated: 12 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: IPD will not be available

Publications

Friedman BW, Irizarry E, Solorzano C, Zias E, Pearlman S, Wollowitz A, Jones MP, Shah PD, Gallagher EJ. A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain. Ann Emerg Med. 2019 Oct;74(4):512-520. doi: 10.1016/j.annemergmed.2019.02.017. Epub 2019 Apr 5.
PubMed 30955985

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial
ClinicalTrials.gov ID: NCT03068897
Acronym / sponsor ID: 2017-7566
Conditions: Low Back Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 3 May 2017 (actual)
Primary completion: 11 Jul 2018 (actual)
Study completion: 11 Oct 2018 (actual)
First posted: 3 Mar 2017 (actual)
Results: Posted 12 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Metaxalone	Active comparator	Drug: Metaxalone, Drug: Ibuprofen 600 mg, Behavioral: Educational interventionIbuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention.
Tizanidine	Active comparator	Drug: Tizanidine, Drug: Ibuprofen 600 mg, Behavioral: Educational interventionIbuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention.
Baclofen	Active comparator	Drug: Baclofen, Drug: Ibuprofen 600 mg, Behavioral: Educational interventionIbuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention.
Placebo	Placebo comparator	Drug: Ibuprofen 600 mg, Behavioral: Educational interventionIbuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days. All participants receive a brief educational intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Present to ED primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in the elderly.
Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.

Key exclusion criteria (6 listed)

Not available for follow-up
Pregnant or breast-feeding
Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
Allergic to or intolerant of investigational medications
Contra-indications to non-steroidal anti-inflammatory drugs: 1) history of hypersensitivity to NSAIDs or aspirin 2) active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed 3) Severe heart failure (NYHA 2 or worse) 4) hypertension (JNC7 stage 2 or worse) 5) Chronic kidney disease 3 or worse 6) Current use of anti-coagulants 7) Hepatitis 8) Alcoholism

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MetaxaloneMetaxalone 400-800mg	Drug	Metaxalone
TizanidineTizanidine 2-4mg	Drug	Tizanidine
BaclofenBaclofen 10-20mg	Drug	Baclofen
Ibuprofen 600 mgIbuprofen	Drug	Baclofen, Metaxalone, Placebo, Tizanidine
Educational interventionResearch personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.	Behavioural	Baclofen, Metaxalone, Placebo, Tizanidine

Primary outcome

Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
Time frame: Baseline and 7 days
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.

3 secondary outcomes

Number of Participants Who Experience Change in Low Back Pain
Time frame: Baseline and 7 days
Number of Participants With Need for Medication for Low Back Pain
Time frame: 7 days
Levels of Disability
Time frame: 7 days

Results and safety

Results posted to the registry on 12 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metaxalone	80	76
Tizanidine	80	76
Baclofen	80	79
Placebo	80	74

Primary outcome: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)

Time frame: Baseline and 7 days. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Metaxalone n = 76	Tizanidine n = 76	Baclofen n = 79	Placebo n = 74
Value	10.1 (8.0 to 12.3)	11.2 (9.2 to 13.2)	10.6 (8.6 to 12.7)	11.1 (9.0 to 13.3)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metaxalone	0 of 80 (0%)	6 of 80 (7.5%)	0 of 80
Tizanidine	0 of 80 (0%)	6 of 80 (7.5%)	0 of 80
Baclofen	0 of 80 (0%)	7 of 80 (8.8%)	0 of 80
Placebo	0 of 80 (0%)	5 of 80 (6.3%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30955985Friedman BW, Irizarry E, Solorzano C, Zias E, Pearlman S, Wollowitz A, Jones MP, Shah PD, Gallagher EJ. A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain. Ann Emerg Med. 2019 Oct;74(4):512-520. doi: 10.1016/j.annemergmed.2019.02.017. Epub 2019 Apr 5.
Individual participant dataSharing planned: No. IPD will not be available

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metaxalone, Tizanidine and Baclofen in people with Low Back Pain, run by Montefiore Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) (time frame: Baseline and 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03068897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.