Clinical trial NCT04509440: Efficacy of Neural Prolotherapy for Treatment of Anserine Bursitis "NPCAB"
Official title: Efficacy of Neural Prolotherapy Versus Local Corticosteroid Soft Tissue Injection for Treatment of Anserine Bursitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anserine Bursitis
Keywords: Anserine bursitis
Neural prolotherapy
Perineural injection
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Western Ontario McMasters Universities osteoarthritis index (WOMAC)
timeFrame: 4 weeks
measure: assessment of overall Anserine bursitis pain severity was done using visual analogue scale
timeFrame: 4 weeks
measure: patient's global assessment of AB severity was done using VAS
timeFrame: 4 weeks
measure: tenderness on the anserine bursa region
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University
Study officials:
affiliation: University of Alexandria
name: Emmanuel K Saba, MD
role: PRINCIPAL_INVESTIGATOR
References: