Effects of Hyaluronic Acid Injection and Exercise Treatments in Knee Osteoarthritis

NCT ID: NCT06196021

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-01
• Study Completion Date: 2006-12-29

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Grup 1 quadriceps strengthening exercises

The patients in group 1 received Quadriceps strengthening exercises with isokinetic dynamometer device. Strengthening exercises were applied to the Quadriceps muscle group by the physiotherapist for 4 weeks, 3 days a week, 30 minutes a day, for a total of 12 sessions.

All patients received patient education and intra-articular hyaluronic acid injection (once a week, 3 times in total) into the symptomatic knee.

Patient education: Just before the start of treatment, an education program consisting of general information about their disease, daily activity modifications and knee joint protection principles was applied by the physician to the patients within a period of approximately 10-15 minutes.

Group Type: ACTIVE_COMPARATOR

Intra-articular hyaluronic acid injection

Intervention Type: OTHER

Hyaluronic acid was injected into the symptomatic knees of the patients a total of 3 times, once a week for 3 weeks.

Injections were administered by the physician using a lateral approach with the patient lying on his back and the knee in full extension.

After each injection, patients were warned to apply cold to avoid possible local reactions and not to overload for 24 hours.

Hyaluronic acid preparation was in the form of 2.5 ml solutions obtained biotechnologically, containing 10 mg sodium hyaluronan in each milliliter.

The hyaluronan in solution was of medium molecular weight (0.9 million daltons) but still lower molecular weight than the hyaluronan in normal healthy synovial fluid.

Grup 2 a home exercise program

The patients in group 2 received a home exercise program. A home exercise program consisting of knee joint range of motion, quadriceps adjustment, and strengthening exercises for abductor and adductor muscle groups was demonstrated by the physiotherapist.They were asked to do the exercises 5 days a week, 2 times a day, with 10 repetitions. Patients were called every 15 days and asked to continue their home exercise program.

All patients received patient education and intra-articular hyaluronic acid injection (once a week, 3 times in total) into the symptomatic knee.

Patient education: Just before the start of treatment, an education program consisting of general information about their disease, daily activity modifications and knee joint protection principles was applied by the physician to the patients within a period of approximately 10-15 minutes.

Group Type: ACTIVE_COMPARATOR

Intra-articular hyaluronic acid injection

Intervention Type: OTHER

Hyaluronic acid was injected into the symptomatic knees of the patients a total of 3 times, once a week for 3 weeks.

Injections were administered by the physician using a lateral approach with the patient lying on his back and the knee in full extension.

After each injection, patients were warned to apply cold to avoid possible local reactions and not to overload for 24 hours.

Hyaluronic acid preparation was in the form of 2.5 ml solutions obtained biotechnologically, containing 10 mg sodium hyaluronan in each milliliter.

The hyaluronan in solution was of medium molecular weight (0.9 million daltons) but still lower molecular weight than the hyaluronan in normal healthy synovial fluid.

Grup 3 did not receive exercise

The patients in group 3 did not receive an exercise program.

All patients received patient education and intra-articular hyaluronic acid injection (once a week, 3 times in total) into the symptomatic knee.

Patient education: Just before the start of treatment, an education program consisting of general information about their disease, daily activity modifications and knee joint protection principles was applied by the physician to the patients within a period of approximately 10-15 minutes.

Group Type: PLACEBO_COMPARATOR

Intra-articular hyaluronic acid injection

Intervention Type: OTHER

Hyaluronic acid was injected into the symptomatic knees of the patients a total of 3 times, once a week for 3 weeks.

Injections were administered by the physician using a lateral approach with the patient lying on his back and the knee in full extension.

After each injection, patients were warned to apply cold to avoid possible local reactions and not to overload for 24 hours.

Hyaluronic acid preparation was in the form of 2.5 ml solutions obtained biotechnologically, containing 10 mg sodium hyaluronan in each milliliter.

The hyaluronan in solution was of medium molecular weight (0.9 million daltons) but still lower molecular weight than the hyaluronan in normal healthy synovial fluid.

Interventions

Intra-articular hyaluronic acid injection

Hyaluronic acid was injected into the symptomatic knees of the patients a total of 3 times, once a week for 3 weeks.

Injections were administered by the physician using a lateral approach with the patient lying on his back and the knee in full extension.

After each injection, patients were warned to apply cold to avoid possible local reactions and not to overload for 24 hours.

Hyaluronic acid preparation was in the form of 2.5 ml solutions obtained biotechnologically, containing 10 mg sodium hyaluronan in each milliliter.

The hyaluronan in solution was of medium molecular weight (0.9 million daltons) but still lower molecular weight than the hyaluronan in normal healthy synovial fluid.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balikesir University

OTHER

Sponsor Role: lead

Responsible Party

Bilal Uysal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bilal Uysal

Role: PRINCIPAL_INVESTIGATOR

Balikesir University

Locations

Balikesir University

Balıkesir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Knee Osteoarthritis

Identifier Type: -

Identifier Source: org_study_id