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

Osteoarthritis Knees Both Clinical Trial

Official 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:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887844
• Other study ID #: AIBU-FTR-MFY-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2021
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 15, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Osteoarthritis
• Osteoarthritis Knees Both
• Osteoarthritis, Knee

Intervention

Drug:
• 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.
• 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.

Other:
• 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

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Western Ontario and McMaster Universities Osteoarthritis Index	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."	eight weeks
Secondary	3-meter walk test	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.	eight weeks