Anserine Bursitis Clinical Trial
Official title:
Efficacy of Neural Prolotherapy Versus Local Corticosteroid Soft Tissue Injection for Treatment of Anserine Bursitis
| NCT number | NCT04509440 |
| Other study ID # | 0303902 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 1, 2018 |
| Est. completion date | October 30, 2019 |
| Verified date | August 2020 |
| Source | University of Alexandria |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Anserine bursitis is a common etiology of medial knee pain. It could be severe enough to
limit the patient's functional abilities with affection of the quality of life. The etiology
of AB is unknown. It could be bursitis, tendinitis or other unknown etiology.
The treatment of AB includes conservative and surgical treatment. Conservative treatment
consists of non-pharmacologic treatment and pharmacologic treatment. Local corticosteroid
injection is a treatment for refractory chronic anserine bursitis.
Neural prolotherapy is the subcutaneous perineural injection of isotonic dextrose 5% in water
solution at the fascial penetration point of the sensory nerve where it reaches the
subcutaneous plane and along its course. It can be used for the treatment of chronic anserine
bursitis.
This study aimed to determine the efficacy of neural prolotherapy subcutaneous perineural
injection versus corticosteroid local soft tissue injection therapy for relieving pain and
improvement of function among patients with chronic anserine bursitis.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | October 30, 2019 |
| Est. primary completion date | October 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. Chronic anserine bursitis was based on clinical manifestations, which was the presence of pain in the medial and inferior aspect of the knee. It was increased during going upstairs and downstairs associated with tenderness on the inferomedial aspect of the knee joint about 5 cm below the medial knee joint line and occasionally local swelling. It could be associated with morning pain and stiffness. 2. Patients who were refractory to conservative treatment for at least 3 months were considered to have chronic anserine bursitis. Each knee was assessed separately for eligibility. Exclusion Criteria: - Symptomatic knee osteoarthritis. - Internal derangement of the knee. - Previous knee surgery. - Prior surgery in the affected knee region. - Systemic rheumatologic disorders. - Fibromyalgia. - Diabetes mellitus. - Endocrine disorders. - Metabolic disorders. - Coagulopathy. - Anticoagulant treatment. - Current skin or soft tissue infection at or near the site of injection. - Prior local soft tissue injection of corticosteroid for anserine bursitis in the past year. - Prior neural prolotherapy for anserine bursitis in the past year. - Patients presented with a systemic active inflammatory condition or infection. - Pregnancy. - Unwillingness to participate in the study. - History of allergy to the used corticosteroid and/or local anaesthetic. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Medicine, Alexandria University | Alexandria |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alexandria |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Western Ontario McMasters Universities osteoarthritis index (WOMAC) | It is a questionnaire that assesses knee pain, stiffness and physical function. The scale of difficulty for different questions was classified based on the following scale: 0=none, 1=slight, 2=moderate, 3=severe and 4=extreme). WOMAC total score ranges from 0 to 104 points. The lower scores indicate better status | 4 weeks | |
| Primary | assessment of overall Anserine bursitis pain severity was done using visual analogue scale | It is a visual analogue scale (VAS) (a 10-cm horizontal scale) in which it ranged from 0 (no pain), to 10 (severe intolerable pain) | 4 weeks | |
| Primary | patient's global assessment of AB severity was done using VAS | patient's global assessment of Anserine bursitis severity was done using VAS (a 10-cm horizontal scale) in which it ranged from 0 (negligible severity), to 10 (very severe disorder). | 4 weeks | |
| Primary | tenderness on the anserine bursa region | clinical assessment for the presence of tenderness on the anserine bursa region was done. | 4 weeks |