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

NCT ID: NCT04887844

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-15

Brief Summary

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

Detailed Description

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Several treatment options have been tried with varying success rates, including nonsteroidal anti-inflammatory drugs, physiotherapy modalities, cold application with ice-packs, and injection of local anesthetics and/or corticosteroids. Despite a relatively high frequency of this painful condition, surprisingly, few studies have evaluated treatment strategies in randomized controlled study design. To the best of our knowledge, no study in the literature made a comparison of the efficacy of local anesthetic and corticosteroid injections in addition to physiotherapy in the treatment of pes anserine bursitis yet. Thus, we aimed to compare the treatment efficacies of physiotherapy alone, physiotherapy + local anesthetic injection, and physiotherapy + local corticosteroid injection in a randomized controlled study design in patients with concomitant osteoarthritis and pes anserine bursitis.

Conditions

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Osteoarthritis Knees Both

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group I was received physiotherapy+lidocaine injection, Group II was received physiotherapy+betamethasone dipropionate injection, and group III was only received conventional physiotherapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participant will be evaluated at baseline, 6 weeks later by an another investigator who does not aware of groups.

Study Groups

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Group I

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.

Group Type ACTIVE_COMPARATOR

Lidocaine injection

Intervention Type 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.

Group II

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.

Group Type ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type 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.

Group III

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.

Group Type OTHER

Conventional Physical therapy

Intervention Type 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

Interventions

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Lidocaine injection

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.

Intervention Type DRUG

Corticosteroid injection

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.

Intervention Type DRUG

Conventional Physical therapy

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

Intervention Type OTHER

Other Intervention Names

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Jetokain, Edaka İlaç AŞ, Turkey Diprospan, Merck Sharp Dohme Inc., USA

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Fatih YAŞAR

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa Fatih Yaşar, MD

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant Izzet Baylsa University

Ramazan KURUL, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant Izzet Baylsa University

Locations

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Abant Izzet Baysal University

Bolu, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AIBU-FTR-MFY-01

Identifier Type: -

Identifier Source: org_study_id

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