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NCT Number: NCT06653985

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Femoracetabular Impingement Femoroacetabular Impingement Syndrome Joint Diseases Labrum Injury of the Hip Joint Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ArthroBiologix

Hamilton, Ontario, Canada

Location status: Recruiting

Location contact

Olufemi Ayeni, FRCSC

PRINCIPAL_INVESTIGATOR

Steven Phillips

CONTACT

[email protected]

(289) 389-8181

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic and corticosteroid injection

Drug

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

Physical Therapy

Other

Patients will receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: 6 months post-injection

    NPRS is scored by asking the patient to circle the number between 0 and 10 that fits best to their pain intensity. Zero represents "no pain" whereas the upper limit of 10 represents "worst possible pain". The patient score is determined as a score out of 10 based on where they indicate their pain falls by selecting a number between 0 and 10 which most accurately represents their pain.

Secondary outcomes

  1. International Hip Outcome Tool 12 item (iHOT-12)

    Time frame: 6 months post-injection

    The tool consists of 12 VAS questions evaluating 4 areas: symptoms and functional limitations, sports and recreational activities, job-related concerns, and social, emotional, and lifestyle concerns. The patient score is determined by averaging the score of the 12 items in the iHOT-12 and is presented on a scale of 0-100, with 0 representing the worst possible function and 100 representing the best possible function.

  2. EuroQol-5D-5L (EQ-5D)

    Time frame: 6 months post-injection

    A quality-of-life measurement instrument that provides a score based on 5 dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This brief questionnaire is self-reported by the patient and determines a quality of life score between 0 and 1, where 1 represents perfect health and 0 represents death.

  3. Medication Use

    Time frame: 6 months post-injection

    Patient medication use, including types (analgesics, NSAIDs, opioids) will be asked at baseline. Patient will then be asked at 3- and 6- months if they are currently using pain medication, and if so whether their use has decreased, stayed the same, or increased.

  4. Adverse Events

    Time frame: 6 months post-injection

    Adverse events experienced over the course of the study will be documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Steven Phillips

CONTACT

[email protected]

(289) 389-8181

Sponsors and collaborators

Lead sponsor

ArthroBiologix Inc.

Industry

Registry information

Official study title

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

Acronym: NON-OP HIP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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