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Recruiting NCT06653985

Intra-articular Corticosteroid With Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP)

No phase Interventional Osteoarthritis Femoroacetabular Impingement Syndrome Labrum Injury of the Hip Joint

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronic and corticosteroid injection, Physical Therapy.
Who it may be relevant to
Registry conditions: Osteoarthritis, Femoroacetabular Impingement Syndrome, Labrum Injury of the Hip Joint. Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intra-articular Corticosteroid With Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP) - a Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Numeric Pain Rating Scale (NPRS) [Time frame: 6 months post-injection]
Secondary outcome measures (4)
  • International Hip Outcome Tool 12 item (iHOT-12) [Time frame: 6 months post-injection]
  • EuroQol-5D-5L (EQ-5D) [Time frame: 6 months post-injection]
  • Medication Use [Time frame: 6 months post-injection]
  • Adverse Events [Time frame: 6 months post-injection]

Eligibility criteria

Inclusion criteria

  • Patients aged 40-60 years old.
  • 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.
  • Patients who demonstrate more than 50% reduction in hip pain following a diagnostic injection (ultrasound guided intra-articular anaesthetic only).
  • Able to subsidize private physiotherapy services.
  • Able to provide informed consent.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • ArthroBiologix — Hamilton

Identifiers

NCT: NCT06653985 · nonophip

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗