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NCT Number: NCT04887844

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

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

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Key information

Conditions

Osteoarthritis Knees Both Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Jetokain, Edaka İlaç AŞ, Turkey

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.

Other names: Diprospan, Merck Sharp Dohme Inc., USA

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

Primary outcomes

  1. Visual analogue scale

    Time frame: eight weeks

    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.

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: eight weeks

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire comprising 24 items in three different domains. The index measure pain, stiffness, and physical functional disability. Pain, stiffness, and physical functional disability subscales comprise five, two, and seventeen questions, respectively. All subscales consist of 5 answer choices, which range from zero, "not present," to four, "very severe."

  2. 3-meter walk test

    Time frame: eight weeks

    We used 3MWT to evaluate the walking speed of the study participants. In this test, the individual is instructed to stand up while they are sitting on a chair with arm support. And then, the person is asked to walk as much distance as possible in 3 minutes without running. The walking time is measured in seconds and recorded, and the walking speed is evaluated for the corresponding age group.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

Comparison of the Efficacy of Corticosteroid and Local Anesthetic Injections Combined With Conventional Physiotherapy in Patients With Concomitant Pes Anserine Bursitis and Knee Osteoarthritis:

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 14, 2021
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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