45 Participants Needed

PNS Therapy vs. Steroid Injections for Chronic Knee Pain

SJ
Overseen BySaba Javed, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.13678

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.137910

Research Team

SJ

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.
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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 OverviewThe 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
3Treatment groups
Experimental Treatment
Group I: Group 3 (PNS therapy plus 1 placebo injection)Experimental Treatment2 Interventions
Participants will receive PNS therapy plus 1 placebo injection.
Group II: Group 2 (PNS therapy plus 1 standard steroid injection).Experimental Treatment3 Interventions
Participants will receive PNS therapy plus 1 standard steroid injection.
Group III: Group 1 (standard steroid injection)Experimental Treatment2 Interventions
Participants will receive 1 standard steroid injection.

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

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Approved in United States as Marcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia
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Approved in European Union as Marcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia
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Approved in Canada as Sensorcaine for:
  • Local anesthesia for surgery
  • Acute pain management
  • Spinal anesthesia

Find a Clinic Near You

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.
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.
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.
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]

References

Effect of Steroid in Local Infiltration Analgesia in One-Stage Bilateral Total Knee Arthroplasty: A Paired-Randomized Controlled Study. [2022]
A Comparative Study of Botulinum Toxin: A with Triamcinolone Compared to Triamcinolone alone in the treatment of Osteoarthritis of Knee. [2022]
Efficacy of Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection in Carpal Tunnel Syndrome: An Open-Label Randomized Control Trial. [2022]
Dexamethasone as adjuvant for femoral nerve block following knee arthroplasty: a randomized, controlled study. [2018]
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty: A Randomized, Controlled Trial. [2021]
Long- or short-acting anesthetic with corticosteroid in local injections of overuse injuries? A prospective, randomized, double-blind study. [2013]
Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. [2022]
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]
A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]
10.United Statespubmed.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]