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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic and corticosteroid injection with physical therapy | Experimental | Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolaneâ„¢) mixed with 40 mg triamcinolone (Kenalogâ„¢) 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. |
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| Hyaluronic and corticosteroid injection | Active Comparator | Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolaneâ„¢) mixed with 40 mg triamcinolone (Kenalogâ„¢) into their hip joint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic and corticosteroid injection | Drug | Patients will receive an ultrasound-guided injection consisting of 3 ml hyaluronic acid (Durolaneâ„¢) mixed with 40 mg triamcinolone (Kenalogâ„¢) into their hip joint. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Phillips | Contact | (289) 389-8181 | steve.phillips@myorthoevidence.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ArthroBiologix | Recruiting | Hamilton | Ontario | Canada |
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| Physical Therapy | Other | Patients will receive an 8-week physiotherapy protocol, consisting of 8 visits. The protocol will consist of 1 visit per week. |
|
| 6 months post-injection |
| 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. | 6 months post-injection |
| 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. | 6 months post-injection |
| Adverse Events | Adverse events experienced over the course of the study will be documented. | 6 months post-injection |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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