PNS Therapy vs. Steroid Injections for Chronic Knee Pain

Overseen By Saba Javed, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioids

Disqualifiers: Cognitive dysfunction, Drug abuse, Infections, Allergies, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare the effects of the following types of therapy on knee range of motion when given to patients with chronic knee pain: * A standard steroid injection * Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid injection * PNS therapy in combination with a placebo injection Steroid injections are given directly into the knee joints and are considered to be the standard therapy for chronic knee pain. In this study, the injection will be made of the steroid drugs triamcinolone and bupivacaine.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on opioids for reasons other than knee pain, you cannot participate in the trial.

What data supports the effectiveness of the treatment for chronic knee pain?

Research shows that steroids like triamcinolone can enhance pain relief and improve rehabilitation after knee surgery, and bupivacaine, an anesthetic, can reduce pain and opioid use after knee replacement. These findings suggest potential benefits for chronic knee pain management. ^{1 2 3 4 5}

Is triamcinolone safe for use in humans?

Triamcinolone, a type of steroid, has been used in various studies for pain relief in conditions like knee surgery and osteoarthritis, and no significant adverse effects were reported in these studies. ^{1 3 6 7 8}

How does the treatment of Bupivacaine and Triamcinolone for chronic knee pain differ from other treatments?

This treatment combines Bupivacaine, a local anesthetic that numbs the area, with Triamcinolone, a steroid that reduces inflammation, offering both immediate pain relief and longer-term anti-inflammatory effects. This dual-action approach is unique compared to treatments that use only one type of medication. ^{1 3 7 9 10}

Research Team

Saba Javed, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults aged 18-85 with chronic knee pain, treated at the MD Anderson Cancer Center. Eligible participants must have a baseline pain score of 4 or higher and be able to consent. Those with opioid use unrelated to knee pain, cognitive issues, skin infections, recent substance abuse history, or allergies to local anesthetics or steroids cannot join.

Inclusion Criteria

Patient signed informed consent

I am between 18 and 85 years old.

I have chronic knee pain with a pain score of 4 or higher, treated at MD Anderson.

Exclusion Criteria

I am unable to make medical decisions due to cognitive issues.

Patients with recent history (<6 months) of drug or alcohol abuse

I have an open skin wound or am on antibiotics for an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standard steroid injection, PNS therapy plus a standard steroid injection, or PNS therapy plus a placebo injection

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in knee range of motion and pain scores at 30, 60, and 90 days from baseline

12 weeks

3 visits (in-person)

Treatment Details

Interventions

• Bupivacaine
• Peripheral Nerve Stimulation
• Placebo
• Triamcinolone

Trial Overview The study compares three treatments: a standard steroid injection into the knee; peripheral nerve stimulation (PNS) plus steroid injection; and PNS with a placebo. The goal is to see which method best improves knee movement in patients suffering from chronic knee pain.

Participant Groups

Group I: Group 3 (PNS therapy plus 1 placebo injection) Experimental Treatment 2 Interventions

Participants will receive PNS therapy plus 1 placebo injection.

Group II: Group 2 (PNS therapy plus 1 standard steroid injection). Experimental Treatment 3 Interventions

Participants will receive PNS therapy plus 1 standard steroid injection.

Group III: Group 1 (standard steroid injection) Experimental Treatment 2 Interventions

Participants will receive 1 standard steroid injection.

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

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study of 45 patients undergoing bilateral total knee arthroplasty, the addition of steroids to local infiltration analgesia significantly reduced pain levels and improved rehabilitation outcomes compared to LIA without steroids, particularly in the first week post-surgery.

Steroid-treated knees showed better range of motion and quicker recovery of active straight leg raises, with no increase in complications or adverse effects observed over a 1-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Steroid in Local Infiltration Analgesia in One-Stage Bilateral Total Knee Arthroplasty: A Paired-Randomized Controlled Study. Chan, VWK., Chan, PK., Yan, CH., et al.[2022]

In a study of 30 patients with severe knee osteoarthritis, the combination of intra-articular Botulinum toxin-A (BoNT-A) and Triamcinolone provided significantly better pain relief compared to Triamcinolone alone, particularly noted from 4 weeks to 6 months post-treatment.

The results indicate that using BoNT-A alongside steroids not only improves pain relief but also enhances functional outcomes, suggesting it could be a more effective treatment option for managing severe knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of Botulinum Toxin: A with Triamcinolone Compared to Triamcinolone alone in the treatment of Osteoarthritis of Knee. Shukla, D., Sreedhar, SK., Rastogi, V.[2022]

Dexamethasone sodium phosphate is as effective as triamcinolone acetonide in treating mild to moderate carpal tunnel syndrome (CTS), showing significant improvements in symptoms and nerve conduction parameters over four months.

Dexamethasone is a safer option since it does not carry the risk of permanent nerve injury associated with triamcinolone if accidentally injected into the nerve, and it also resulted in less post-procedural pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection in Carpal Tunnel Syndrome: An Open-Label Randomized Control Trial. Mathew, MM., Gaur, R., Gonnade, N., et al.[2022]

Adding dexamethasone to bupivacaine for femoral nerve blocks significantly prolonged the duration of analgesia from 18.8 hours to 25.7 hours, enhancing pain management after total knee replacement surgery.

While total morphine consumption was similar between the two groups, patients receiving dexamethasone required less morphine in the first 6 hours post-surgery, indicating improved early pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone as adjuvant for femoral nerve block following knee arthroplasty: a randomized, controlled study. Sherif, AA., Elsersy, HE.[2018]

In a study involving 63 total knee arthroplasty patients, liposomal bupivacaine (LB) provided better pain relief during activity on the first postoperative day compared to standard bupivacaine (SB), with lower pain scores (4.4 vs 5.9).

Patients receiving LB also required fewer opioids in the first two days after surgery (51.2 vs 66.1 on day 1 and 39.5 vs 54.8 on day 2), indicating a potential benefit in reducing opioid consumption post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty: A Randomized, Controlled Trial. Hubler, CP., Bevil, KM., Greiner, JJ., et al.[2021]

In a study of 56 patients with overuse sports injuries, the long-acting anesthetic bupivacaine provided better pain relief in the first six hours after local corticosteroid injections compared to the short-acting lidocaine.

Both anesthetic groups showed similar long-term outcomes, with about two-thirds of patients experiencing significant pain relief and half achieving full recovery to sports, suggesting that while bupivacaine offers initial advantages, both options are effective for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long- or short-acting anesthetic with corticosteroid in local injections of overuse injuries? A prospective, randomized, double-blind study. Kannus, P., Järvinen, M., Niittymäki, S.[2013]

Intraarticular triamcinolone acetonide significantly reduced acute pain after arthroscopic knee surgery, with lower pain scores observed from 6 to 24 hours post-surgery compared to the saline control group.

Patients receiving triamcinolone required significantly less rescue analgesia, with none requesting additional pain relief compared to 53% in the saline group, highlighting its efficacy as a local pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. Wang, JJ., Ho, ST., Lee, SC., et al.[2022]

In a 26-week study involving 215 patients with osteoarthritis, hylan G-F 20 (HG-F 20) provided significantly better pain relief and functional improvement compared to triamcinolone hexacetonide (TH) at both 12 and 26 weeks.

HG-F 20 demonstrated a longer duration of effect and was better tolerated, with no patients discontinuing treatment due to lack of efficacy, while 15 patients treated with TH did discontinue for this reason.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. Caborn, D., Rush, J., Lanzer, W., et al.[2015]

In a double-blind study involving 30 patients with rheumatoid arthritis, all three intra-articular steroid preparations (prednisolone t-butyl acetate, methyl prednisolone acetate, and triamcinolone hexacetonide) showed thermographic improvement in knee synovitis, with triamcinolone demonstrating the greatest and longest-lasting effect.

Despite the local improvements in knee symptoms, no significant overall systemic improvement was observed after a single injection of any steroid, although all three preparations suppressed the body's natural cortisol production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. Bird, HA., Ring, EF., Bacon, PA.[2022]

In a study of 60 patients who underwent total knee arthroplasty (TKA), those receiving perineural injection therapy (PIT) showed significantly better pain management and functional outcomes compared to those receiving standard postoperative care, as measured by the WOMAC and VAS scores.

PIT demonstrated high clinical efficacy with 93.5% of patients reporting excellent or good outcomes, while also being a cost-effective and safe treatment option with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. Güzel, İ., Gül, D., Akpancar, S., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of Steroid in Local Infiltration Analgesia in One-Stage Bilateral Total Knee Arthroplasty: A Paired-Randomized Controlled Study. [2022]

2. India pubmed.ncbi.nlm.nih.gov

A Comparative Study of Botulinum Toxin: A with Triamcinolone Compared to Triamcinolone alone in the treatment of Osteoarthritis of Knee. [2022]

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

Efficacy of Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection in Carpal Tunnel Syndrome: An Open-Label Randomized Control Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Dexamethasone as adjuvant for femoral nerve block following knee arthroplasty: a randomized, controlled study. [2018]

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

Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty: A Randomized, Controlled Trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Long- or short-acting anesthetic with corticosteroid in local injections of overuse injuries? A prospective, randomized, double-blind study. [2013]

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

Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. [2015]

9. England pubmed.ncbi.nlm.nih.gov

A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]

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

Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. [2021]