Clinical trial NCT06653985: Intra-articular Corticosteroid with Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP)
Official title: Intra-articular Corticosteroid with Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP) - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Femoroacetabular Impingement Syndrome
Labrum Injury of the Hip Joint
Keywords: Hip
Osteoarthritis
Femoroacetabular impingement
Labral tear
Hyaluronic acid
Corticosteroid
Physical Therapy
Physiotherapy
Lead sponsor: ArthroBiologix Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 40-60 years old.
2. Patients with mild hip arthritis (Kellgren-Lawrence grade 2 or lower) with or without a labral tear and/or femoroacetabular impingement and/or mild hip dysplasia.
3. Patients who demonstrate more than 50% reduction in hip pain following a diagnostic injection (ultrasound guided intra-articular anaesthetic only).
4. Able to subsidize private physiotherapy services.
5. Able to provide informed consent.

Exclusion Criteria:

1. Active infection
2. Osteonecrosis of the hip, moderate to severe arthritis (Kellgren-Lawrence grade 3 or higher), or moderate-to-severe hip dysplasia
3. Previous hip fracture, pelvic fracture, or lower limb fracture,
4. Previous surgery to the pelvis, hip or lower limb
5. Hypermobility disorder or connective tissue disease (e.g. Ehler's-Danlos syndrome, Marfan's syndrome etc.)
6. Patients with chronic low back pain and/or sciatica
7. Patients who received an intra-articular steroid hip injection within 3 months
8. Patients who have previously received a hyaluronic acid injection
9. Injuries sustained in a motor vehicle collision.
10. Injuries sustained in the workplace and have a worker's compensation claim.
11. Injuries resulting in a medico-legal dispute.
12. Patients who are pregnant of planning to become pregnant
13. Currently enrolled in a study that does not permit co-enrollment
14. Unable to obtain informed consent
15. Unable to comply with the study protocol
16. Contraindication to corticosteroid or hyaluronic acid injection
17. Prior enrollment in the study.

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 months post-injection
Secondary outcomes:
measure: International Hip Outcome Tool 12 item (iHOT-12)
timeFrame: 6 months post-injection
measure: EuroQol-5D-5L (EQ-5D)
timeFrame: 6 months post-injection
measure: Medication Use
timeFrame: 6 months post-injection
measure: Adverse Events
timeFrame: 6 months post-injection
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: ArthroBiologix
state: Ontario
Study officials:
References: