Haloperidol for Back Pain

Overseen By Jessica McCoy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Western Michigan University School of Medicine

Disqualifiers: Traumatic injury, Saddle anesthesia, Bowel dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether haloperidol, a medication, can alleviate back pain for individuals visiting the emergency department. Participants will receive either haloperidol or another medication, ketorolac, and researchers will assess their pain levels at various intervals. The trial seeks individuals with non-traumatic, sudden-onset, severe back pain. It excludes those whose pain results from an injury or who have serious symptoms like numbness or bowel issues. Individuals with ongoing intense back pain and no major injuries may find this trial suitable. As a Phase 4 trial, this research involves an FDA-approved treatment to better understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for these treatments?

Research has shown that haloperidol is approved for treating conditions like schizophrenia and other mental illnesses, indicating it has been studied for safety in humans. Some studies suggest haloperidol might also aid in pain relief, particularly in emergencies. However, it can cause side effects, such as infection, fever, or lower back or side pain.

Researchers are now testing haloperidol in a Phase 4 trial for back pain, which suggests it is generally considered safe. Phase 4 trials typically assess how well a treatment works in large groups and identify any rare side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for back pain, like NSAIDs or muscle relaxants, focus on reducing inflammation or relaxing muscles. But haloperidol works differently, targeting the central nervous system to potentially alter pain perception. This unique mechanism could offer relief for those who don't respond well to traditional options. Researchers are excited about this approach because it opens up the possibility of managing pain more effectively in patients with chronic back pain.

What evidence suggests that Haloperidol might be an effective treatment for back pain?

Research shows that haloperidol, which participants in this trial may receive, can help relieve pain, including back pain. One study found it effective for severe pain from conditions like radiation fibrosis. Other research suggests that haloperidol works well for pain because it also addresses the mental aspect of pain. Additionally, haloperidol can reduce the need for opioids in pain management, making it a promising option for treating pain in emergency situations. Meanwhile, another treatment arm in this trial will evaluate the effectiveness of Ketorolac, used as an active comparator. ^{1 2 4 6 7}

Who Is on the Research Team?

Jessica McCoy, MD

Principal Investigator

Western Michigan University Homer Stryker M.D. School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who come to the Bronson ED with acute, non-traumatic back pain and a pain score over 5 cm. It's not suitable for those outside this age range or with different types of back pain.

Inclusion Criteria

My pain level is more than 5 on a scale of 0 to 10.

I went to the ER because my back suddenly started hurting without any injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either Haloperidol or Ketoralac and symptom levels are recorded at 30, 60, and 90 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment via telephone

24 hours

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Haloperidol

Trial Overview The study tests Haloperidol against Ketorolac Tromethamine for managing acute musculoskeletal back pain in the ED. Patients are randomly assigned to either drug, and their symptoms are tracked at intervals up to 90 minutes, with a follow-up call after 24 hours.

How Is the Trial Designed?

Group I: Haloperidol Experimental Treatment 1 Intervention

Haloperidol 5 mg IM haloperidol

Group II: Ketoralac Active Control 1 Intervention

Ketoralac 30 mg IM

Haloperidol is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium

Approved in European Union as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium
• Tourette's syndrome

Approved in Canada as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium

Approved in Japan as Haldol for:

• Schizophrenia
• Acute psychosis
• Agitation
• Delirium

Who Is Running the Clinical Trial?

Western Michigan University School of Medicine

Lead Sponsor

Trials

6

Recruited

560+

Bronson Methodist Hospital

Collaborator

Trials

3

Recruited

3,600+

Published Research Related to This Trial

In a study of 107 patients with non-specific abdominal pain, those treated with haloperidol had significantly lower milligram morphine equivalents (MME) compared to those receiving conventional opioid therapy, indicating haloperidol's potential to reduce opioid use.

Patients receiving haloperidol also had lower rates of rescue therapy administration, suggesting that haloperidol may be an effective alternative for managing abdominal pain without relying heavily on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Haloperidol for Abdominal Pain in the Emergency Department (SHAPE). Knudsen-Lachendro, K., Stith, K., Vicarel, LA., et al.[2021]

The DANTE study is a phase IV clinical trial designed to evaluate the effectiveness and safety of a combination of dexketoprofen and tramadol (DKP/TRAM) in treating moderate to severe acute low back pain, involving a large cohort of patients with varying histories of low back pain.

The primary goal is to determine how quickly patients can achieve significant pain relief (NRS-PI score < 4 or a ≥30% reduction in pain) within 8 hours of the first dose, while also comparing the efficacy and safety of this combination against tramadol alone over multiple doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DANTE Study: The First Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Arm Group Study Evaluating the Analgesic Efficacy and Safety of Dexketoprofen TrometAmol aNd Tramadol Hydrochloride Oral FixEd Dose Combination on Moderate to Severe Acute Pain in Patients with Acute Low Back Pain-Rationale and Design. Varrassi, G., Hanna, M., Coaccioli, S., et al.[2023]

In a study of 105 patients with lower back pain from lumbar disc herniation, pregabalin did not show a significant advantage over placebo in reducing pain after 12 weeks, despite both groups reporting pain reduction.

The most common side effects of pregabalin were somnolence and dizziness, indicating that while it may be safe, its efficacy in this context is questionable and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Pregabalin Versus Placebo in Reduction of Pain due to Lumber Disc Herniation. Kataria, D., Jumani, L., Ahmed, MU., et al.[2020]

Haloperidol has shown promise in significantly reducing or eliminating the need for narcotic analgesics in patients with intractable pain syndromes, based on previous reports of 10 patient cases.

The ongoing controlled double-blind study aims to evaluate Haloperidol's effectiveness as an adjunctive treatment for intractable cancer pain, exploring its potential analgesic properties and relationship to opiate receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia and haloperidol: a hypothesis. Maltbie, AA., Cavenar, JO., Sullivan, JL., et al.[2022]

Hydromorphone extended release (ER) significantly reduced pain intensity in patients with chronic low back pain (LBP), maintaining improvements during a 12-week double-blind phase after initial stabilization, with mean pain scores decreasing from around 6.5 to 3.3.

The treatment was generally well tolerated, with adverse event rates ranging from 47% to 57% across different phases, indicating that while side effects were common, they did not outweigh the benefits of pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: a post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial. Nalamachu, S., Hale, M., Khan, A.[2014]

Flupirtine modified release (MR) 400 mg was found to be non-inferior to tramadol extended release (ER) 200 mg and superior to placebo in reducing chronic low back pain, with significant improvements in pain intensity observed over 4 weeks in a study involving 363 patients.

Flupirtine MR had a lower incidence of treatment-emergent adverse events compared to tramadol ER, suggesting a better safety profile, while also demonstrating tolerability similar to that of placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study. Uberall, MA., Mueller-Schwefe, GH., Terhaag, B.[2022]

In a 6-week study involving 207 patients with chronic low back pain, OROS hydromorphone significantly reduced pain levels and improved overall effectiveness ratings from both patients and investigators.

While the treatment was effective, common mild to moderate side effects included constipation, nausea, headache, and somnolence, which are typical for opioid therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127). Wallace, M., Skowronski, R., Khanna, S., et al.[2019]

Haloperidol was found to be an effective pain reliever for a patient suffering from severe radiation fibrosis and necrosis, both on its own and when used with opiates.

This case supports previous findings that haloperidol can enhance pain relief, suggesting the need for further clinical trials to explore its potential as an analgesic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haloperidol analgesia. Daw, JL., Cohen-Cole, SA.[2022]

Morphine was found to be more effective at inhibiting complex pain responses in mice compared to spinal reflexes, indicating its stronger impact on higher-level pain processing.

The neuroleptic drug haloperidol enhanced the pain-relieving effects of both morphine and the delta-agonist DADL, particularly at a specific dose, suggesting potential for combining treatments to improve pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of haloperidol on the analgesic activity of opiate agonists administered intracisternally and intrathecally]. Chichenkov, ON., Korobov, NV., Petrov, VE.[2013]

The combination of haloperidol and morphine significantly enhances pain relief in neuropathic pain without causing major side effects like constipation or motor incoordination, based on tests conducted over 10 days post-surgery.

Using haloperidol with morphine delays the development of morphine tolerance, allowing for more effective pain management over a longer period compared to morphine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haloperidol potentiates antinociceptive effects of morphine and disrupt opioid tolerance. Mena-Valdés, LC., Blanco-Hernández, Y., Espinosa-Juárez, JV., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11357606/

Haloperidol for Pain Management: A Narrative Review - PMC The most robust clinical data from the past decade suggest that haloperidol has good efficacy in the treatment of pain related to gastroparesis ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7665221/

Characterizing the role of haloperidol for analgesia in the ... The majority of providers (73.9%) believed that haloperidol was effective because there is a psychiatric component to pain, while over half of ...

3. withpower.com withpower.com/trial/phase-4-chronic-pain-4-2024-a4e4a

Haloperidol for Back Pain Haloperidol was found to be an effective pain reliever for a patient suffering from severe radiation fibrosis and necrosis, both on its own and when used with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675719303493

Does administration of haloperidol or ketorolac decrease ... Haloperidol and ketorolac have been recommended as therapies that may decrease opioid use for treatment of pain in emergency department patients.

5. mdanderson.elsevierpure.com mdanderson.elsevierpure.com/en/publications/haloperidol-for-pain-management-a-narrative-review

Haloperidol for Pain Management: A Narrative Review The most robust clinical data from the past decade suggest that haloperidol has good efficacy in the treatment of pain related to gastroparesis and migraines ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/haloperidol-intramuscular-route/description/drg-20072783

Haloperidol (intramuscular route) - Side effects & uses Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, ...

7. go.drugbank.com go.drugbank.com/drugs/DB00502

Haloperidol: Uses, Interactions, Mechanism of Action Haloperidol is an antipsychotic agent used to treat schizophrenia and other psychoses, as well as symptoms of agitation, irritability, and delirium.