Shoulder Injections for Shoulder Osteoarthritis
Recruiting in Palo Alto (17 mi)
Overseen ByPatrice Tétreault, MD FRCSC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Disqualifiers: Rotator cuff tear, Pregnancy, Avascular necrosis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial compares two types of injections for shoulder osteoarthritis. It targets patients with moderate to severe pain and limited mobility. One injection combines a lubricating substance with an anti-inflammatory drug, while the other uses only an anti-inflammatory drug. The goal is to see which injection provides better pain relief and improves joint function. Diclofenac etalhyaluronate (DF-HA) has been studied for its effectiveness and safety in treating osteoarthritis in various joints, showing significant pain relief particularly in the hip joint.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had a cortisone injection in the last 6 months or a platelet-rich plasma or hyaluronic acid injection in the last 12 months, you cannot participate.
What data supports the effectiveness of the drug for shoulder osteoarthritis?
Research shows that both triamcinolone hexacetonide and hyaluronic acid, components of the treatment, have been used to reduce pain and improve joint function in osteoarthritis of the knee and hand. This suggests they may also help with shoulder osteoarthritis.
12345Is the treatment of shoulder osteoarthritis with triamcinolone injections safe?
Research indicates that triamcinolone injections, including extended-release versions, have been evaluated for safety in patients with shoulder osteoarthritis. These studies generally support the safety and tolerability of triamcinolone injections in humans.
13678How does the drug Triamcinolone Hexacetonide combined with hyaluronic acid differ from other treatments for shoulder osteoarthritis?
This drug combination is unique because it combines Triamcinolone Hexacetonide, a steroid that reduces inflammation, with hyaluronic acid, which acts as a lubricant in the joint, potentially offering both pain relief and improved joint function. This dual approach may provide benefits over treatments that use only one of these components.
2691011Eligibility Criteria
This trial is for adults aged 20-90 with moderate to severe primary shoulder osteoarthritis, who can read and understand French or English. They must have pain of at least 4/10 on the visual scale and be able to fill out questionnaires. Exclusions include those with certain shoulder injuries, recent related treatments, pregnancy, joint diseases like avascular necrosis or infections, cognitive impairments that prevent questionnaire comprehension.Inclusion Criteria
I can read and understand either French or English.
I have arthritis in both shoulders but will choose one side for the study.
The patient must have the cognitive ability to read and fill out the questionnaires
+3 more
Exclusion Criteria
I do not have any serious health issues that prevent me from joining the study.
I might have or do have an active infection.
Presence of a transfixing rotator cuff tear assessed on MRI
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Pre-infiltration Evaluation
Standard x-ray and MRI examination, demographic data collection, medical history review, and completion of 2 questionnaires
1 week
1 visit (in-person)
Treatment
Participants receive a single intra-articular infiltration of either Cingal or cortisone under fluoroscopy
1 day
1 visit (in-person)
Follow-up
Participants complete electronic questionnaires and maintain a medication diary at 1, 3, and 6 months post-infiltration
6 months
3 visits (virtual)
Participant Groups
The study compares two types of shoulder injections for pain relief in osteoarthritis: one combining Cingal (sodium hyaluronate and triamcinolone) versus just cortisone (triamcinolone). It's a randomized controlled trial where participants are chosen by sealed envelopes to determine which treatment they receive.
2Treatment groups
Experimental Treatment
Active Control
Group I: CingalExperimental Treatment1 Intervention
A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide
Group II: CortisoneActive Control1 Intervention
A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%
Triamcinolone Hexacetonide is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Aristospan for:
- Osteoarthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Bursitis
- Tendinitis
- Gouty arthritis
🇨🇦 Approved in Canada as Kenalog for:
- Osteoarthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Bursitis
- Tendinitis
- Gouty arthritis
🇪🇺 Approved in European Union as Triamcinolone Hexacetonide for:
- Osteoarthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Bursitis
- Tendinitis
- Gouty arthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Hospitalier de l'Université de Montréal (CHUM)Montreal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
Intra-articular hyaluronic acid compared to intra-articular triamcinolone hexacetonide in inflammatory knee osteoarthritis. [2019]The aim of this study was to determine the comparative efficacy and safety of intra-articular (i/a) triamcinolone. hexacetonide (TH) and i/a hyaluronic acid (HA) in inflammatory knee osteoarthritis. A randomized double-blind comparative trail was carried out in a rheumatology outpatient department. There were 63 patients (24 male, 39 female, mean age 70.5 years) with bilateral symptomatic knee osteoarthritis with effusion. Each was given five HA injections at weekly intervals; or 20 mg TH followed by four placebo (saline) injections. Patients were examined weekly during the treatment period and then at monthly intervals for a further 6 months. Assessment included recording of: visual analog scores (VAS) for pain; duration of stiffness; range of movement; joint effusion; local heat; synovial thickening; joint-line and periarticular tenderness. The principal outcome measure was pain on a self-selected activity assessed by Vas. The two groups were comparable at entry and no significant differences between the groups developed at any time during the treatment period. However, there was a high drop-out rate and intention to treat analysis failed to demonstrate statistically significant differences between the groups. In patients remaining in the study, significantly less pain was experienced by the HA group during the 6 month follow-up period. Other parameters showed a similar trend in favor of experienced by the HA group during the 6 month follow-up period. Other parameters showed a similar trend in favor of HA. We could not, however, demonstrate significant differences between the placebo and active treatments. HA may therefore be a useful additional therapy for symptomatic knee osteoarthritis and may have a long duration of action.
HYLAN G-F 20 VERSUS TRIAMCINOLONE IN THE TREATMENT OF PRIMARY SHOULDER OSTEOARTHRITIS. RANDOMIZED TRIAL. [2022]The aim of this study was to evaluate the effect of using an intra-articular injection of hylan G-F 20 (HA group) on primary shoulder osteoarthritis compared with an intra-articular triamcinolone injection (T group).
Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis ‒ A double-blinded randomized controlled trial with a one year follow-up. [2022]to evaluate the effectiveness of triamcinolone Hexacetonide (TH) Intra-Articular Injection (IAI) in hand Interphalangeal Joints (IP) of Osteoarthritis (OA) patients to improve pain and joint swelling; improve function, goniometry, and grasping force, and assess IAI influence on radiographic evolution over 1-year.
The intra-articular administration of triamcinolone hexacetonide in the treatment of osteoarthritis. Its effects in a naturally occurring canine osteoarthritis model. [2023]To evaluate the effect of an intra-articular (IA) administration of triamcinolone hexacetonide, compared with saline.
Clinical evidence in the treatment of rotator cuff tears with hyaluronic acid. [2022]the aim of this quantitative review is to document potential benefit and adverse effects of hyaluronic acid (HA) injection into the shoulder with rotator cuff tears.
A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. [2022]The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac in the treatment of external shoulder impingement syndrome.
Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. [2023]Osteoarthritis (OA) is a major public health burden. While knee and hip joints are most commonly affected, the glenohumoral (shoulder) joint is also frequently involved. We evaluated the pharmacokinetics and safety/tolerability of triamcinolone acetonide extended-release (TA-ER) and triamcinolone acetonide crystalline suspension (TAcs) in patients with shoulder OA.
Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. [2017]To evaluate the effectiveness and tolerance of intraarticular injection (IAI) of triamcinolone hexacetonide (TH) for the treatment of osteoarthritis (OA) of hand interphalangeal (IP) joints.
Subacromial triamcinolone acetonide, hyaluronic acid and saline injections for shoulder pain an RCT investigating the effectiveness in the first days. [2022]Subacromial impingement is a common cause of shoulder complaints in general practice. When the initial treatment with acetaminophen and low dose Non Steroidal Anti Inflammatory Drugs fails, triamcinolone acetonide injections are commonly used. Triamcinolone acetonide injections are effective at four to six weeks. Little is known about the pain relief effect of triamcinolone acetonide injections in the first days after injection and the effect of repeated injection. In this study we investigate the effect of triamcinolone acetonide injections compared to hyaluronic acid and NaCl injections using a pain diary.
Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. [2021]In symptomatic tendinosis, a corticosteroid injection into the subacromial space is a palliative treatment option. This study compares high volumes (10 cc) of local anesthetic (LA) combined with triamcinolone acetate (TA) with low volumes (4 cc) of LA combined with TA to see whether the latter would provide similar pain, function and complication outcomes for subacromial injections in patients with impingement syndrome.
Osteo-arthritis of the hip treated by intraneural injection. A simplified technique for the relief of intractable osteo-arthritic pain. [2019]A new method of treating osteo-arthritis of the hip involving an intraneural injection of a depot steroid, Triamcinolone Hexacetonide, is described. The results are superior to the more conventional method of systemic or intra-articular route of steroid administration. The rapidity of action in the relief of spasm and pain would tend to confirm similar results shown in a previous article in the Journal.