Efficacy of Corticosteroid and Local Anesthetic Injections Patients With Concomitant Pes Anserine Bursitis

NCT04887844 | Completed DMC

• 1 other identifier: AIBU-FTR-MFY-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficiencies of local corticosteroid injections and local anesthetics in patients with concomitant pes anserine bursitis and osteoarthritis.

Conditions

Osteoarthritis Knees Both

Keywords

Pain; Knee; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  We used paper-based VAS to evaluate the baseline severity and changes in the intensity of pain by different interventions in the entire study cohort. The visual analogue scale was devised by Hayes and Patterson and is used to document pain rating. Subjects self-report the intensity of their pain by placing a handwritten mark at one point of the length of a ten-centimeter line. The two ends of the scale line represent "no pain" and "worst pain experienced" at the zero cm and 10th cm of the scale, respectively.

  eight weeks

Secondary Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index

  eight weeks

• 3-meter walk test

  eight weeks

Study Arms (3)

Group I

ACTIVE COMPARATOR

34 patients who were diagnosed with concomitant knee osteoarthritis and pes anserine bursitis and met inclusion criteria were included in the study. Inclusion criteria were as follows: having stage II-IV knee osteoarthritis along with pes anserine bursitis, duration of symptoms for more than three months, and age between 20 and 70 years. Primary knee osteoarthritis was diagnosed as per American College of Rheumatology (ACR) criteria and graded via Kellgren-Lawrence radiological classification included in this study.

Drug: Lidocaine injection

Group II

ACTIVE COMPARATOR

34 patients who were diagnosed with concomitant knee osteoarthritis and pes anserine bursitis and met inclusion criteria were included in the study. Inclusion criteria were as follows: having stage II-IV knee osteoarthritis along with pes anserine bursitis, duration of symptoms for more than three months, and age between 20 and 70 years. Primary knee osteoarthritis was diagnosed as per (ACR) criteria and graded via Kellgren-Lawrence radiological classification included in this study.

Drug: Corticosteroid injection

Group III

OTHER

34 patients who were diagnosed with concomitant knee osteoarthritis and pes anserine bursitis and met inclusion criteria were included in the study. Inclusion criteria were as follows: having stage II-IV knee osteoarthritis along with pes anserine bursitis, duration of symptoms for more than three months, and age between 20 and 70 years. Primary knee osteoarthritis was diagnosed as per (ACR) criteria and graded via Kellgren-Lawrence radiological classification included in this study.

Other: Conventional Physical therapy

Interventions

Lidocaine injection DRUG

Lidocaine injection were applied to the most tender point in the pes anserine region by means of the soft tissue infiltration technique only once at the commencement of the treatment period. All injections were performed by the same physician.

Also known as: Jetokain, Edaka İlaç AŞ, Turkey

Group I

Corticosteroid injection DRUG

Corticosteroid injection were applied to the most tender point in the pes anserine region by means of the soft tissue infiltration technique only once at the commencement of the treatment period. All injections were performed by the same physician.

Also known as: Diprospan, Merck Sharp Dohme Inc., USA

Group II

Conventional Physical therapy OTHER

The study participants underwent a physiotherapy program that included a one-time 15-minute cold therapy using ice packs and closed-kinetic chain quadriceps strengthening program as follows; isometric quadriceps exercise, isokinetic concentric, and eccentric quadriceps exercises with heel slides and squads. These exercises were repeated ten times a day, seven days per week, for eight weeks in total

Group III

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having stage II-IV knee osteoarthritis along with pes anserine bursitis
• Symptom onset for more than three months

You may not qualify if:

• Patients who underwent knee operations
• had an inflammatory rheumatic disease
• had a history of knee trauma
• had a meniscus tear
• valgus/varus deformity
• received injection treatment to pes anserine bursa during the preceding year

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Adrenal Cortex Hormones; betamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mustafa Fatih Yaşar, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

• Ramazan KURUL, Ph.D

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant will be evaluated at baseline, 6 weeks later by an another investigator who does not aware of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Group I was received physiotherapy+lidocaine injection, Group II was received physiotherapy+betamethasone dipropionate injection, and group III was only received conventional physiotherapy.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 15, 2020
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

TU (1)