Hyaluronic + Corticosteroid Injections and Physical Therapy for Hip Issues

(NON-OP HIP Trial)

Overseen By Steven Phillips

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: ArthroBiologix Inc.

Must not be taking: Steroid injections

Disqualifiers: Infection, Osteonecrosis, Fractures, Hypermobility, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Hip pathologies that cause pain and functional limitations are common in the general population. These can include femoroacetabular impingement (FAI), labral tears and mild osteoarthritis (OA) among others. While more severe and symptomatic cases may require surgical intervention, the treatment of mild-to-moderate cases is often treated without surgery to relieve pain, improve function, and delay surgical intervention. Non-operative treatments of hip pathologies consist of a multitude of options. A common non-operative intervention includes intra-articular injections, including corticosteroids and hyaluronic acid. Evidence has demonstrated that corticosteroids have fast acting effects which tend to diminish within a few months, while hyaluronic acid has a delayed time of onset and demonstrates clinical benefit for a longer period of time. Studies have evaluated combinations of corticosteroid and hyaluronic acid, hoping to take advantage of the fast-acting relief of corticosteroid and the longer lasting benefits of corticosteroid. Physiotherapy is also a frequent non-operative intervention used to relieve pain and increase function in patients with hip pathologies. While many studies have looked at intra-articular injections and physiotherapy as independent non-operative possibilities for hip conditions, the combined effect of these two have not received much evaluation. The purpose of this study is to evaluate the effect of physiotherapy in conjunction with a combined corticosteroid and hyaluronic acid intraarticular injection on patient outcomes when compared to a corticosteroid and hyaluronic acid intraarticular injection alone.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Intra-articular Corticosteroid, Physiotherapy, Pelvic Floor Physical Therapy, Pelvic Health Physiotherapy, PFMT (Pelvic Floor Muscle Training) for hip issues?

Research shows that intra-articular corticosteroid injections can reduce pain in hip osteoarthritis, especially when other pain relief methods don't work. Using ultrasound guidance for these injections can improve accuracy and effectiveness. ^{1 2 3 4 5}

Is the combination of hyaluronic acid and corticosteroid injections with physical therapy safe for hip issues?

Studies show that hyaluronic acid injections for hip osteoarthritis are generally safe, with minor side effects that usually go away within a week. However, corticosteroid injections before hip replacement surgery have been linked to higher infection rates, so caution is advised. ^{2 6 7 8 9}

How is the drug Intra-articular Corticosteroid different from other treatments for hip issues?

Intra-articular corticosteroid injections are unique because they are directly injected into the hip joint, providing targeted pain relief for hip osteoarthritis. They are more effective than hyaluronic acid and platelet-rich plasma in reducing pain, and a higher dose can offer longer-lasting benefits without increasing infection risk. ^{2 4 10 11 12}

Eligibility Criteria

This trial is for individuals with mild-to-moderate hip pain and functional limitations due to conditions like femoroacetabular impingement, labral tears, or osteoarthritis. It's not suitable for those needing surgery or who have severe symptoms.

Inclusion Criteria

Able to subsidize private physiotherapy services

Able to provide informed consent

I am between 40 and 60 years old.

Exclusion Criteria

Injuries sustained in the workplace and have a worker's compensation claim

I have had surgery on my pelvis, hip, or lower limb.

Injuries sustained in a motor vehicle collision

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an ultrasound-guided injection of hyaluronic acid and triamcinolone, with an 8-week physiotherapy protocol for the experimental group

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and quality of life assessments

6 months

Treatment Details

Interventions

• Intra-articular Corticosteroid
• Physiotherapy

Trial Overview The study tests if combining a corticosteroid and hyaluronic acid injection with physiotherapy improves outcomes in hip pathology patients compared to the injection alone.

Participant Groups

Group I: Hyaluronic and corticosteroid injection with physical therapy Experimental Treatment 2 Interventions

Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint. Patients will also receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.

Group II: Hyaluronic and corticosteroid injection Active Control 1 Intervention

Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolane™) mixed with 40 mg triamcinolone (Kenalog™) into their hip joint.

Who Is Running the Clinical Trial?

ArthroBiologix Inc.

Lead Sponsor

Trials

2

Recruited

260+

References

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

Intraarticular cortisone injection for osteoarthritis of the hip. Is it effective? Is it safe? [2021]

2. England pubmed.ncbi.nlm.nih.gov

Single-Dose Intra-Articular Administration of a Hybrid Cooperative Complex of Sodium Hyaluronate and Sodium Chondroitin in the Treatment of Symptomatic Hip Osteoarthritis: A Single-Arm, Open-Label, Pilot Study. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Pain reduction and improvement of function following ultrasound-guided intra-articular injections of triamcinolone hexacetonide and hyaluronic acid in hip osteoarthritis. [2018]

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

Symposium: evidence for the use of intra-articular cortisone or hyaluronic acid injection in the hip. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial. [2021]

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

Intra-articular injection of hyaluronic acid (MW 1,500-2,000 kDa; HyalOne) in symptomatic osteoarthritis of the hip: a prospective cohort study. [2022]

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

Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. [2022]

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

Efficacy of intra-articular hyaluronic acid injections in hip osteoarthritis: a meta-analysis of randomized controlled trials. [2019]

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

Intra-Articular Hyaluronic Acid Injections Less Than 6 Months Before Total Hip Arthroplasty: Is It Safe? A Retrospective Cohort Study in 565 Patients. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

Safety of intra-articular hip injection of hyaluronic acid products by ultrasound guidance: an open study from ANTIAGE register. [2016]

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

Intra-articular treatment with triamcinolone compared with triamcinolone with hyaluronate: A randomised open-label multicentre clinical trial in 80 lame horses. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Ultrasound-Guided Intra-Articular Injections with Hyaluronic Acid and Corticosteroids in Patients with Hip Osteoarthritis: A Long-Term Real-World Analysis. [2023]