Clinical trial NCT06196021: Effects of Hyaluronic Acid Injection and Exercise Treatments in Knee Osteoarthritis
Official title: Effects of Hyaluronic Acid Injection and Exercise Therapies on Proprioception, Gait Analysis and Quality of Life in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Hyaluronic Acid Injection
Exercise
Gait Analysis
Proprioception
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: Osteoarthritis (OA) is one of the most common joint diseases that most often causes physical disability. Physical therapy modalities, exercise programs and intra-articular injections are widely used in the treatment of OA.

Purpose: The aim of this study is to investigate the effects of adding different exercise treatments to hyaluronan injection on proprioception, muscle strength and quality of life in patients with knee OA.

Methods: A total of 54 patients were included in the study and were randomized into three groups. Quadriceps strengthening exercises were applied to the patients in Group 1, a home exercise program was applied to the patients in Group 2, and no exercise program was applied to the patients in Group 3. Additionally, all patients received patient education and intra-articular hyaluronic acid injection into the symptomatic knee. Standard forms were filled out to evaluate the patients' pain, functional status and quality of life. Muscle strength and proprioception were evaluated with an isokinetic dynamometer. Changes in the patients' walking parameters were evaluated by gait analysis. Evaluations were made at the beginning of treatment, at the end of treatment, and at the 3rd and 6th months of treatment.

Detailed description: Background: Osteoarthritis (OA) is one of the most common joint diseases that most often causes physical disability. The most common type of osteoarthritis with the highest incidence in the clinic is knee osteoarthritis. Physical therapy modalities, exercise programs and intra-articular injections are widely used in the treatment of knee OA.

Purpose: The aim of this study is to investigate the effects of adding different exercise treatments to hyaluronan injection on proprioception, muscle strength and quality of life in patients with knee OA.

Methods: A total of 54 patients with stage II and III primary knee OA were included in the study. The patients included in the study were divided into 3 groups by randomization. For randomization, envelopes containing the letters A, B and C were prepared for the patients included in the study. The patients included in the study randomly selected one of the envelopes. Patients who chose the envelope with the letter A were included in the 1st group, patients who chose the envelope with the letter B were included in the 2nd group, and patients who chose the envelope with the letter C were included in the 3rd group. The researchers who made the assessment measurements were unaware of which patient was in which group. Statistical analysis of the results was performed by a biostatistician who had no information about the therapies the patient groups received. Quadriceps strengthening exercises were applied to the patients in Group 1 with the isokinetic dynamometer device, a home exercise program was applied to the patients in Group 2, and no exercise program was applied to the patients in Group 3. Additionally, all patients received patient education and intra-articular hyaluronic acid injection (once a week, 3 times in total) into the symptomatic knee. Standard forms were filled out to evaluate the patients' pain, functional status and quality of life. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne knee index and The Health Assessment Questionnaire (HAQ) scales were used to evaluate the patients' functional status and quality of life. Visual Analogue Scale (VAS) was used to evaluate the pain conditions of the patients. Muscle strength and proprioception were evaluated with an isokinetic dynamometer. Changes in the patients' walking parameters were evaluated by gait analysis. Evaluations were made at the beginning of treatment, at the end of treatment, and at the 3rd and 6th months of treatment.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary knee osteoarthritis according to American College of Rheumatology (ACR) diagnostic criteria
* Patients with a radiological diagnosis of stage 2 and 3 primary knee osteoarthritis according to the Kellgren \& Lawrence Scale
* Patients with knee osteoarthritis between the ages of 45-65
* Patients giving informed written consent

Exclusion Criteria:

* Patients diagnosed with secondary knee osteoarthritis
* Patients with decompensated organ failure that prevents them from exercising
* Patients with lower extremity neurological deficits affecting gait and proprioception
* Patients who had fracture affecting the knee joints, patients who underwent a surgical intervention, patients who underwent intraarticular injection for knees within the last 6 months,
* Inflammatory rheumatic disorders
* Patients using anticoagulant medication
* Patients with bleeding disorders
* Malignancy
* Patients who are pregnant
* Patients who are with diabetes
* Patients who are with active vestibular disease

Primary outcomes:
measure: Visual Analogue Scale-pain,
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
measure: Lequesne knee index
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
measure: The Health Assessment Questionnaire
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
Secondary outcomes:
measure: Muscle strength
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
measure: Proprioception
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
measure: Walking parameters
timeFrame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balikesir University
Study officials:
affiliation: Balikesir University
name: Bilal Uysal
role: PRINCIPAL_INVESTIGATOR
References: