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

NCT ID: NCT04509440

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-10-30

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.

Conditions

Anserine Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

isotonic dextrose 5% in water (D5W) solution

Intervention Type: DRUG

Neurol prolotherapy (NP) is the subcutaneous perineural injection of isotonic dextrose 5% in water (D5W) solution.

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.

Group Type: ACTIVE_COMPARATOR

corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% )

Intervention Type: DRUG

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.

Interventions

isotonic dextrose 5% in water (D5W) solution

Neurol prolotherapy (NP) is the subcutaneous perineural injection of isotonic dextrose 5% in water (D5W) solution.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Subcutaneous nerual prolotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Emmanuel Kamal Aziz Saba

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emmanuel K Saba, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

Faculty of Medicine, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0303902

Identifier Type: -

Identifier Source: org_study_id