PNS Therapy vs. Steroid Injections for Chronic Knee Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
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.
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.
567910Do 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.
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.
137810Eligibility 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.Participant Groups
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.
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:
🇺🇸 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
References
A thermographic and clinical comparison of three intra-articular steroid preparations in rheumatoid arthritis. [2022]We have compared three intra-articular steroid preparations in a double blind study on 30 patients with rheumatoid arthritis and bilateral synovitis of the knees. One knee was injected with 1.0 ml of either prednisolone t-butyl acetate, methyl prednisolone acetate, or triamcinolone hexacetonide, and the patients were followed up for 6 weeks with regular clinical and thermographic assessments. Thermographic improvement was seen with all 3 drugs but was greatest initially and longest lasting with triamcinolone. No significant systemic improvement was seen with any drug after a single injection, though all 3 steroid preparations suppressed endogenous cortisol.
Long- or short-acting anesthetic with corticosteroid in local injections of overuse injuries? A prospective, randomized, double-blind study. [2013]A prospective, randomized, double-blind study of 56 patients presenting with an overuse sports injury was undertaken in order to compare the effect of a long-acting anesthetic (bupivacaine) with a short-acting anesthetic (lidocaine) in local corticosteroid injections. At presentation, patients were either administered a periarticular injection of 2 ml of methyl prednisolone acetate with bupivacaine (MPA-B) (40 mgs per ml + 5 mgs per ml) or 2 ml of MPA with lidocaine (MPA-L) (40 mgs per ml + 10 mgs per ml). No other treatment was given. Results indicated that pain inhibition was better in the MPA-B group during the first six hours after the injection, obviously because of the longer half-life of bupivacaine. In later evaluations no differences could be observed: in both groups pain disappeared partly or completely in two-thirds of the patients and full recovery to sports was possible in half of them. Long-acting bupivacaine is recommended as an anesthetic substance in local steroid injections of musculoskeletal overuse injuries.
Intraarticular triamcinolone acetonide for pain control after arthroscopic knee surgery. [2022]Intraarticular corticosteroids provide valuable local therapy for chronic joint pain caused by inflammatory joint diseases. In this inpatient study, we evaluated the effect of intraarticular triamcinolone acetonide on acute pain after arthroscopic knee surgery. Sixty patients who underwent arthroscopic knee surgery under spinal anesthesia were enrolled into this double-blind, randomized trial. At the end of surgery, Group 1 (n = 30) received intraarticular triamcinolone acetonide 10 mg in isotonic saline 20 mL, and Group 2 (n = 30) received intraarticular isotonic saline 20 mL. After surgery, pain was assessed by using a visual analog scale. The time to first analgesic request (IV morphine) was recorded, and the proportion of patients requiring rescue analgesia was calculated. The results demonstrated that patients in Group 1 had lower pain scores than those in Group 2 from 6 to 24 h postoperatively (P
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]To assess prospectively the efficacy and tolerability of hylan G-F 20 (HG-F 20; Synvisc) and intraarticular triamcinolone hexacetonide (TH; Aristospan) for treatment of osteoarthritis (OA) knee pain in a 26 week, randomized, multicenter, evaluator-blind study.
Dexamethasone as adjuvant for femoral nerve block following knee arthroplasty: a randomized, controlled study. [2018]We examined the effect of the addition of dexamethasone to bupivacaine for femoral nerve blocks on the block duration and the quality of post-operative analgesia following total knee replacement surgery.
A Comparative Study of Botulinum Toxin: A with Triamcinolone Compared to Triamcinolone alone in the treatment of Osteoarthritis of Knee. [2022]This study compares the efficacy in terms of pain relief and complications of intra-articular Botulinum toxin-A (BoNT-A) with intra-articular Triamcinolone versus Triamcinolone alone in the treatment of osteoarthritic knee pain of severe grade. If effective, BoNT-A may help in reducing the long term adverse effects due to prolonged analgesic consumption and reduce/delay requirement of knee replacement surgeries.
Effect of Steroid in Local Infiltration Analgesia in One-Stage Bilateral Total Knee Arthroplasty: A Paired-Randomized Controlled Study. [2022]Although local infiltration analgesia (LIA) is effective in relieving pain after total knee arthroplasty (TKA), its effect is short lasting and the optimal combination of drugs is unknown. Steroids being a potent and long-acting anti-inflammatory drug might extend LIA's effect. This study aims to evaluate the role of steroids in LIA. This is a paired-randomized controlled study involving one-stage bilateral TKA patients. LIA containing ropivacaine, ketorolac, and adrenaline with or without triamcinolone was given. One knee was randomized to receive LIA with steroids, while the other received LIA without steroids. The primary outcome was knee pain in terms of the visual analog scale (VAS). Secondary outcomes were rehabilitation progress, functional scores, and complications. Outcomes were compared between the knees of the same patient and documented up to 1 year. A total of 45 patients (90 TKAs) were included. LIA with steroid knees showed lower VAS score at rest and during activity from postoperation day 1 to 5 and at 6 weeks (p < 0.05). Passive and active range of movement was also greater in LIA with steroid group from day 1 to 7 and day 2 to 5, respectively (p < 0.05). Steroid-treated knees also achieved active straight leg raise earlier (1.2 vs. 2.0 days, p < 0.05). No differences in Knee Society Score and complication rates between both groups. Steroids in LIA offer additional and extended benefit in pain control and rehabilitation after TKA, while no adverse effects were found up to 1-year follow-up.
Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. [2021]BACKGROUND Despite increased experience and technical developments in total knee arthroplasty (TKA), chronic postsurgical pain (CPSP) remains one of physicians' biggest challenges. The aim of the present study was to evaluate the effectiveness of perineural injection therapy (PIT) in the management of CPSP after TKA. MATERIAL AND METHODS A total of 60 patients who had been surgically treated with TKA because of advanced knee osteoarthritis was included in the present study. The study included 2 groups. Group A consisted of patients who received 3 rounds of PIT combined with standard postoperative TKA protocol during the same period. Group B received standard postoperative TKA protocols (rehabilitation programs, oral and intravenous analgesics). Clinical effectiveness was evaluated via Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analog Scale (VAS) at baseline and 1-, 3-, and 6-month follow-ups. RESULTS All repeated measures showed significant improvements (P
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty: A Randomized, Controlled Trial. [2021]Peripheral nerve blocks are commonly used in total knee arthroplasty (TKA). Liposomal bupivacaine is an extended-release anesthetic medication that maintains efficacy upwards of 72 hours. This study compared single-shot liposomal bupivacaine (LB) with the standard single-shot bupivacaine (SB) in a preoperative adductor canal block in TKA patients. A double-blind randomized, controlled trial at a single institution was performed in patients undergoing TKA. A standard preoperative single-shot adductor canal nerve injection was performed in 31 patients using 266 mg of liposomal bupivacaine (20 mL), whereas 32 patients received a standard formulation of 0.5% bupivacaine hydrogen chloride (20 mL). The primary outcome measure was postoperative gait velocity. Secondary outcomes included knee range of motion, pain scores, patient satisfaction, knee extension strength, opioid consumption, length of stay, and adverse events. There were no differences in baseline measures between groups. Improved pain ratings with activity (P=.009) were noted on postoperative day 1 with LB (mean, 4.4; SD, 2.0) compared with SB (mean, 5.9; SD, 2.6). Fewer opioids were used with LB compared with SB on postoperative day 1 (mean, 51.2 vs 66.1; P=.020) and on postoperative day 2 (mean, 39.5 vs 54.8; P=.016). No statistically significant differences in gait velocity, knee range of motion, knee extension strength, or patient satisfaction occurred. Peripheral nerve blockade with a single-shot adductor canal injection demonstrated improved pain scores with activity and diminished postoperative narcotic use when using LB compared with SB in TKA patients. There may be early postoperative advantages with LB as a single-shot injection in adductor canal blockade for patients undergoing TKA. [Orthopedics. 2021;44(4):249-255.].
Efficacy of Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection in Carpal Tunnel Syndrome: An Open-Label Randomized Control Trial. [2022]Introduction Perineural corticosteroid injection is an extensively used and accepted treatment for carpal tunnel syndrome (CTS). However, to this date, there is no guideline as to which corticosteroid has to be used as the standard treatment for CTS. Triamcinolone acetonide is a commonly used particulate steroid that can cause permanent nerve injury if it is accidentally injected into the nerve. Conversely, dexamethasone sodium phosphate is a nonparticulate steroid that would not cause permanent nerve damage following accidental injection. Methods Mild to moderate cases of CTS, confirmed by nerve conduction studies (NCS), with symptoms greater than three months were recruited. The participants received one session of ultrasound-guided perineural injection by the in-plane axial ulnar-sided approach with 4 mL of either dexamethasone (dexamethasone sodium phosphate 8 mg (2 mL) + 2 mL 0.5% bupivacaine) or triamcinolone (triamcinolone acetonide 40 mg/mL (1 mL) + 2 mL 0.5% bupivacaine + 1 mL normal saline) solution. The parameters assessed were Phalen's test time (in seconds), visual analog scale (VAS), and Boston carpal tunnel questionnaire (BCTQ) scores at baseline and two and four months, and NCS changes in sensory nerve conduction velocity (SNCV) and distal motor latency (DML) of the median nerve at baseline and four months. Statistical analysis was conducted using the software SPSS version 26.0 (IBM Corporation, Armonk, NY, USA). Independent samples t-test was used for comparison between groups and the paired t-test for improvement within each group. P values