Efficacy of Neural Prolotherapy for Treatment of Anserine Bursitis "NPCAB"

• ClinicalTrials.gov Identifier: NCT04509440
• Recruitment Status: Completed
• First Posted: August 12, 2020
• Last Update Posted: August 12, 2020
• Sponsor: University of Alexandria
• Information provided by (Responsible Party): Emmanuel Kamal Aziz Saba, University of Alexandria

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anserine Bursitis	Drug: 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% )	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Neural Prolotherapy Versus Local Corticosteroid Soft Tissue Injection for Treatment of Anserine Bursitis
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: October 30, 2019
• Actual Study Completion Date: October 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Neural prolotherapy; Neural prolotherapy using isotonic dextrose 5% in water solution (about 3 ml). The injection was done using Lyftgot technique. The subcutaneous injections were done at sensory nerves fascial penetration points and tender areas around the anserine bursa anatomical region.	Drug: isotonic dextrose 5% in water (D5W) solution; Neurol prolotherapy (NP) is the subcutaneous perineural injection of isotonic dextrose 5% in water (D5W) solution.; Other Name: Subcutaneous nerual prolotherapy
Active Comparator: Corticosteroid group; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Western Ontario McMasters Universities osteoarthritis index (WOMAC) [ Time Frame: 4 weeks ]
   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
2. assessment of overall Anserine bursitis pain severity was done using visual analogue scale [ Time Frame: 4 weeks ]
   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)
3. patient's global assessment of AB severity was done using VAS [ Time Frame: 4 weeks ]
   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. tenderness on the anserine bursa region [ Time Frame: 4 weeks ]
   clinical assessment for the presence of tenderness on the anserine bursa region was done.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Faculty of Medicine, Alexandria University

Alexandria, Egypt, 21131

Sponsors and Collaborators

University of Alexandria

Investigators

• Principal Investigator: Emmanuel K Saba, MD; University of Alexandria

More Information

• Responsible Party: Emmanuel Kamal Aziz Saba, Principal Investigator, University of Alexandria
• ClinicalTrials.gov Identifier: NCT04509440
• Other Study ID Numbers: 0303902
• First Posted: August 12, 2020
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emmanuel Kamal Aziz Saba, University of Alexandria:

Anserine bursitis; Neural prolotherapy; Perineural injection

Additional relevant MeSH terms:

Bursitis; Joint Diseases; Musculoskeletal Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Anesthetics; Mepivacaine; Anesthetics, Local; Triamcinolone diacetate; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Sensory System Agents; Peripheral Nervous System Agents