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

Sponsor

University of Alexandria (Other)

Overall Status

Completed

CT.gov ID

NCT04509440

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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% )	N/A

Detailed Description

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.

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.

Study Design

Study Type:

Interventional

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 :

Oct 30, 2019

Actual Study Completion Date :

Oct 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 Names: 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.

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 Names:

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% )

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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.