Intra-articular Corticosteroid With Hyaluronic Acid Plus Physiotherapy for Hip Pathologies (NON-OP HIP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorArthroBiologix Inc.
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic and corticosteroid injection
DrugPatients 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 interventionPatients will receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Hyaluronic and corticosteroid injection with physical therapyExperimental treatment 2 interventions
Group B: Hyaluronic and corticosteroid injectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Pain Rating Scale (NPRS)
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.
Time frame
6 months post-injectionSecondary outcomes
1
International Hip Outcome Tool 12 item (iHOT-12)
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.
Time frame
6 months post-injection2
EuroQol-5D-5L (EQ-5D)
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.
Time frame
6 months post-injection3
Medication Use
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.
Time frame
6 months post-injection4
Adverse Events
Adverse events experienced over the course of the study will be documented.
Time frame
6 months post-injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov