Trials / Completed
CompletedNCT04509440
Efficacy of Neural Prolotherapy for Treatment of Anserine Bursitis "NPCAB"
Efficacy of Neural Prolotherapy Versus Local Corticosteroid Soft Tissue Injection for Treatment of Anserine Bursitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- University of Alexandria · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. Their aim is pain relieve, with subsequent improvement of function and quality of life. The non-pharmacologic treatment consisted of activity modification with avoidance of precipitating activities and physiotherapy. The pharmacologic treatment consists of non-steroidal anti-inflammatory drugs, analgesics whether oral as acetaminophen or topical preparations; or local soft tissue injection of corticosteroid. Surgical treatment is indicated after failure of conservative treatment in chronic severe and resistant cases only. Local corticosteroid injection is a treatment for refractory chronic anserine bursitis. The mechanism of action of corticosteroid is the suppression of the inflammatory process associated with anserine bursitis. Subsequently, improvement of anserine bursitis takes place. 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. The mechanism of action of neural prolotherapy in anserine bursitis could be due to stimulation the release of a group of growth factors that enhance soft tissue healing in response to isotonic dextrose 5% in water solution injection. Subcutaneous injection of isotonic dextrose 5% in water solution was found to stimulate human cells to start proliferation, increase in cell protein and DNA synthesis. It stimulates the release of a group of growth factors as transforming growth factor-β and other growth factors. Another mechanism of neural prolotherapy is the treatment of neurogenic inflammation. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isotonic dextrose 5% in water (D5W) solution | Neurol prolotherapy (NP) is the subcutaneous perineural injection of isotonic dextrose 5% in water (D5W) solution. |
| DRUG | corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% ) | Corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% ) (local anesthetic). They were given as a single local soft tissue injection at the point of maximal tenderness on the lower medial aspect of the knee region. |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2019-10-30
- Completion
- 2019-10-30
- First posted
- 2020-08-12
- Last updated
- 2020-08-12
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04509440. Inclusion in this directory is not an endorsement.