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

Primary Purpose

Anserine Bursitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
isotonic dextrose 5% in water (D5W) solution
corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% )
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anserine Bursitis focused on measuring Anserine bursitis, Neural prolotherapy, Perineural injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neural prolotherapy

Corticosteroid group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Western Ontario McMasters Universities osteoarthritis index (WOMAC)
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
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
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
clinical assessment for the presence of tenderness on the anserine bursa region was done.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2020
Last Updated
August 8, 2020
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT04509440
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anserine Bursitis
Keywords
Anserine bursitis, Neural prolotherapy, Perineural injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neural prolotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Corticosteroid group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
isotonic dextrose 5% in water (D5W) solution
Other Intervention Name(s)
Subcutaneous nerual prolotherapy
Intervention Description
Neurol prolotherapy (NP) is the subcutaneous perineural injection of isotonic dextrose 5% in water (D5W) solution.
Intervention Type
Drug
Intervention Name(s)
corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% )
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario McMasters Universities osteoarthritis index (WOMAC)
Description
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
Time Frame
4 weeks
Title
assessment of overall Anserine bursitis pain severity was done using visual analogue scale
Description
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)
Time Frame
4 weeks
Title
patient's global assessment of AB severity was done using VAS
Description
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).
Time Frame
4 weeks
Title
tenderness on the anserine bursa region
Description
clinical assessment for the presence of tenderness on the anserine bursa region was done.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel K Saba, MD
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt

12. IPD Sharing Statement

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

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