rTMS + Facet Joint Injections for Chronic Back Pain

Recruiting at 1 trial location

Overseen by Siobhan Schabrun

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must be taking: Steroid injections

Disqualifiers: Serious spinal pathology, Spinal surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic spinal pain (CSP) is one of the most common chronic pain conditions globally. Steroid joint injections (SJI) are a routine treatment option for patients with CLBP that is recalcitrant to other treatments. However, SJI has been shown to have limited long-term efficacy with patients often requiring another injection within months to adequately control pain. One option to prolong the analgesic effects of SJI is to use a type of noninvasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS). Previous studies have shown rTMS may be capable of providing long-term pain relief in patients with chronic back pain. However, the literature on rTMS in patients with CSP is limited and no study has explored rTMS in patients receiving recurrent SJI for pain control. In this pilot randomized controlled trial study, we'll be investigating if combining rTMS with SJI in CSP individuals will enhance or prolong the analgesic effects of SJI alone. The investigators hypothesize that a combined rTMS and SJI intervention will be feasible, tolerable, and safe and will have larger and longer-lasting effects on CSP than a sham rTMS and SJI intervention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have had a consistent medication regimen for the past 3 months, which suggests you may need to continue your current medications.

What data supports the effectiveness of this treatment for chronic back pain?

Research shows that facet joint injections can help relieve pain in patients with chronic low back pain. Additionally, studies suggest that the success of these injections may depend on the patient's overall health and behavior, rather than the specific method of injection. ^{1 2 3 4 5}

Is the combination of rTMS and facet joint injections safe for humans?

Facet joint injections are generally considered safe, but they can have risks like infection, bleeding, and headaches. A rare case of serious infection was reported, highlighting the need for careful monitoring. No specific safety data for rTMS combined with facet joint injections was found, but rTMS alone is generally safe with mild side effects like headaches or scalp discomfort. ^{6 7 8 9 10}

How is the treatment Facet Joint Injection unique for chronic back pain?

Facet Joint Injections are unique because they deliver medication directly into the joints of the spine, targeting the source of pain more precisely than systemic treatments like oral medications. This localized approach can provide more immediate and focused pain relief compared to other treatments that affect the whole body. ^{11 12 13 14 15}

Research Team

Siobhan Schabrun

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

This trial is for individuals at St. Joseph's Health Centre in London, Ontario with chronic spinal pain who've had at least two facet joint injections in the past year and are experiencing significant pain despite treatment. Participants must have been on a stable medication regimen for three months and be able to understand English to give consent.

Inclusion Criteria

I have had 2 steroid injections in my joints in the last year.

I am getting steroid injections for back pain at St. Joseph's in London, Ontario.

Had a consistent medication regimen for the past 3 months

Exclusion Criteria

I do not have serious spine problems like tumors or fractures.

Unable to read, understand, and speak English and unable to give consent

I had spinal surgery within the last year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive active or sham rTMS 3 times each week for 2 weeks to enhance the effects of SJI

2 weeks

6 visits (in-person)

Maintenance Treatment

Participants receive a single active or sham rTMS session in weeks 3, 4, 6, 8, and 12

10 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Weekly assessments (virtual)

Treatment Details

Interventions

• Facet Joint Injection (Corticosteroid)
• repetitive transcranial magnetic stimulation (Other)
• rTMS (Noninvasive Brain Stimulation)
• sham repetitive transcranial magnetic stimulation (Other)

Trial Overview The study tests if combining repetitive transcranial magnetic stimulation (rTMS) with routine facet joint injections (FJI) provides better, longer-lasting relief from chronic spinal pain than FJI alone. It also examines how this combination affects inflammation-related proteins that might influence chronic pain.

Participant Groups

Group I: active repetitive transcranial magnetic stimulation + steroid joint injection Active Control 1 Intervention

Active transcranial stimulation will be delivered for a total of 11 sessions. Each session will consist of 40 trains of 5s delivered at 10 Hz, at an intensity of 85% of the resting motor threshold for the first dorsal interosseous muscle and an intertrain interval of 25s (total of 2000 stimulations in a 20-minute session).

Group II: sham repetitive transcranial magnetic stimulation + steroid joint injection Placebo Group 1 Intervention

The sham repetitive transcranial magnetic stimulation coil will be delivered using a Placebo D70mm Air Film Coil of identical colour, size, and shape as the active rTMS coil. The sham coil uses a magnetic shield that blocks the magnetic field from being delivered to the scalp while producing a similar auditory click during discharge. All other aspects of the rTMS protocol will be identical between the active and sham conditions.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

Findings from Research

MRI-guided lumbar facet joint radiofrequency denervation (FRD) was performed successfully on 17 patients with chronic low back pain, showing no major complications and significant pain reduction over time.

Patients experienced a notable decrease in pain scores from a median of 8 before the procedure to 1 after 6 months, along with an increase in multifidus muscle volume, indicating both safety and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided lumbar facet radiofrequency denervation for treatment of patients with chronic low back pain in an open 1.0 Tesla MRI system. Böning, G., Hartwig, T., Freyhardt, P., et al.[2022]

Facet joint infiltrations provided significant pain relief for 81.8% of patients just 1 hour after the procedure, with sustained relief observed in 62.5% of patients even after 24 weeks, indicating its efficacy for chronic nonradicular low back pain.

The procedure was performed safely with no major complications reported, highlighting its status as a simple and minimally invasive treatment option for selected patients with chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided lumbar facet joint infiltration in nonradicular low back pain. Chaturvedi, A., Chaturvedi, S., Sivasankar, R.[2022]

In a study of 109 patients with chronic unilateral low-back pain, the type of injection (cortisone with local anesthetic vs. saline) did not significantly affect treatment outcomes, suggesting that the injection method may not be as critical as previously thought.

The best predictor of a positive treatment outcome was the presence of inappropriate signs (IAS) before injections, indicating that a patient's psychological and social factors play a crucial role in their recovery from low-back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic unilateral low-back pain. Predictors of outcome of facet joint injections. Lilius, G., Harilainen, A., Laasonen, EM., et al.[2022]

Radiofrequency denervation (RFD) significantly improves pain, reduces the need for analgesics, and enhances patient satisfaction in individuals with chronic low back pain from facet joint issues, based on a study of 44 patients over 2 years.

The benefits of RFD peak at 3 to 6 months post-procedure, with no reported complications, indicating it is a safe and effective short-term treatment option for this type of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective outcome study on the effects of facet joint radiofrequency denervation on pain, analgesic intake, disability, satisfaction, cost, and employment. Burnham, RS., Holitski, S., Dinu, I.[2009]

In a study of 27 patients with failed back surgery syndrome, ultrasound-guided facet joint injections significantly reduced pain levels over six months, with a notable decrease in pain rating scores from 7.0 to 6.0 (p=0.006).

The injections also led to a significant improvement in lumbar flexion, increasing from 50.0° at baseline to 70.0° by the sixth month (p<0.001), indicating enhanced mobility without any reported complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does ultrasound-guided facet joint injection reduce pain and improve mobility in patients with failed back surgery syndrome? Çırak, M., Çağlar Okur, S.[2021]

In a pilot study of 15 patients with chronic low back pain, hylan G-F 20 injections showed significant improvements in pain and disability measures up to 6 months, but these benefits were not sustained at 12 months.

While patient satisfaction increased shortly after treatment, it declined over time, and analgesic usage decreased significantly at 6 months but slightly increased again by 12 months, indicating modest and temporary efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective pilot study of painful lumbar facet joint arthropathy after intra-articular injection of hylan G-F 20. DePalma, MJ., Ketchum, JM., Queler, ED., et al.[2022]

In a study of nine patients with thoracic facet disease, bipolar radiofrequency thermocoagulation resulted in a significant 47.6% reduction in pain, as measured by the Visual Analog Scale (VAS), one month after the procedure.

The treatment was found to be safe, with no serious complications reported, suggesting it could be a viable option for managing mid back pain originating from thoracic facet joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar Intra-articular Radiofrequency Thermocoagulation of the Thoracic Facet Joints: A Case Series of a New Technique. Kim, D.[2021]

Facet joint injections, commonly used to treat chronic low back pain, can lead to serious complications, including a rare case of subdural empyema and meningitis, as seen in a 47-year-old female patient.

This case emphasizes the importance of medical practitioners being vigilant about potential infectious complications following what is generally considered a safe procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subdural empyema following lumbar facet joint injection: An exceeding rare complication. Fayeye, O., Silva, AH., Chavda, S., et al.[2016]

The study involved 166 facet joint blocks performed on 45 patients with lower back pain, demonstrating that MRI-guided injections were technically successful with no major complications reported.

Patients experienced significant pain relief, with a reduction in the visual analogue scale (VAS) score from 7.1 at baseline to 3.5 after one week, indicating that the therapy is both effective and safe for treating lower back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided facet joint injection therapy using an open 1.0-T MRI system: an outcome study. Freyhardt, P., Hartwig, T., De Bucourt, M., et al.[2022]

Ultrasound-guided facet joint injections are feasible and effective for treating chronic low back pain, with 90% of patients showing clear visibility of the facet joints and successful injections.

This method significantly reduces procedure time (average of 14.3 minutes) and radiation exposure (14.2 mGy.cm) compared to CT-guided injections, which took longer (22.3 minutes) and involved much higher radiation doses (364.4 mGy.cm).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided versus computed tomography-controlled facet joint injections in the lumbar spine: a prospective randomized clinical trial. Galiano, K., Obwegeser, AA., Walch, C., et al.[2019]

A 1-week treatment with repetitive transcranial magnetic stimulation (rTMS) significantly reduced pain levels in patients with chronic low back pain, as measured by the visual analogue scale (VAS) and Short Form McGill pain questionnaire (SF-MPQ).

Patients receiving rTMS experienced greater pain relief compared to those undergoing physical therapy, and the treatment was found to be safe with no evident side effects, indicating its potential as an effective long-term pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effect of repetitive transcranial magnetic stimulation (rTMS) in patients with chronic low back pain. Ambriz-Tututi, M., Alvarado-Reynoso, B., Drucker-Colín, R.[2019]

In a study involving 90 patients with Fibromyalgia Syndrome, real low-frequency rTMS applied to the right dorsolateral prefrontal cortex significantly reduced pain and associated symptoms, with effects lasting up to 6 months after treatment.

The sham-rTMS group showed no significant changes, indicating that the benefits of rTMS are likely due to its mechanism of action on spinal pain circuits and top-down modulation of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the prefrontal cortex for fibromyalgia syndrome: a randomised controlled trial with 6-months follow up. Tanwar, S., Mattoo, B., Kumar, U., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive treatment that can provide partial and temporary relief from severe chronic pain, particularly in conditions like neuropathic pain and fibromyalgia.

While rTMS effects are generally short-lived, daily sessions over several weeks can lead to longer-lasting pain relief, and for patients who respond but later relapse, surgical options like implanted electrodes may help maintain the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of repetitive transcranial magnetic stimulation in pain relief. Lefaucheur, JP.[2022]

In a study involving 17 patients with spinal cord injury and chronic neuropathic pain, repetitive transcranial magnetic stimulation (rTMS) did not show a significant advantage over sham treatment in reducing pain levels, indicating that its analgesic effect may not be superior to placebo.

Despite the lack of significant difference compared to sham treatment, rTMS did provide encouraging pain relief at 10 days and 6 weeks post-treatment, suggesting potential for further research with larger sample sizes to explore its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of repetitive transcranial magnetic stimulation on refractory neuropathic pain in spinal cord injury. Yılmaz, B., Kesikburun, S., Yaşar, E., et al.[2021]

Regenerative injection therapy (RIT) showed significant improvements in pain and functional outcomes for fibromyalgia patients compared to repetitive transcranial magnetic stimulation (rTMS), with benefits observed immediately after treatment and one month later.

While RIT was more effective for pain relief and functional improvement, rTMS demonstrated better results in reducing depression symptoms and enhancing cortical auditory evoked potentials, suggesting that a combination of both therapies could optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative injection therapy and repetitive transcranial magnetic stimulation in primary fibromyalgia treatment: A comparative study. Abd Elghany, SE., Al Ashkar, DS., El-Barbary, AM., et al.[2019]

References

1. China pubmed.ncbi.nlm.nih.gov

MR-guided lumbar facet radiofrequency denervation for treatment of patients with chronic low back pain in an open 1.0 Tesla MRI system. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Image-guided lumbar facet joint infiltration in nonradicular low back pain. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic unilateral low-back pain. Predictors of outcome of facet joint injections. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A prospective outcome study on the effects of facet joint radiofrequency denervation on pain, analgesic intake, disability, satisfaction, cost, and employment. [2009]

5. Turkey pubmed.ncbi.nlm.nih.gov

Does ultrasound-guided facet joint injection reduce pain and improve mobility in patients with failed back surgery syndrome? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective pilot study of painful lumbar facet joint arthropathy after intra-articular injection of hylan G-F 20. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Bipolar Intra-articular Radiofrequency Thermocoagulation of the Thoracic Facet Joints: A Case Series of a New Technique. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Subdural empyema following lumbar facet joint injection: An exceeding rare complication. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

MR-guided facet joint injection therapy using an open 1.0-T MRI system: an outcome study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided versus computed tomography-controlled facet joint injections in the lumbar spine: a prospective randomized clinical trial. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Analgesic effect of repetitive transcranial magnetic stimulation (rTMS) in patients with chronic low back pain. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the prefrontal cortex for fibromyalgia syndrome: a randomised controlled trial with 6-months follow up. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Use of repetitive transcranial magnetic stimulation in pain relief. [2022]

14. England pubmed.ncbi.nlm.nih.gov

The effect of repetitive transcranial magnetic stimulation on refractory neuropathic pain in spinal cord injury. [2021]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Regenerative injection therapy and repetitive transcranial magnetic stimulation in primary fibromyalgia treatment: A comparative study. [2019]