Effects of Hyaluronic Acid Injection and Exercise Treatments in Knee Osteoarthritis

NCT06196021 | Completed

• 1 other identifier: Knee Osteoarthritis
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Hyaluronic Acid Injection; Exercise; Gait Analysis; Proprioception

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale-pain,

  Detection of changes in Visual Analogue Scale-pain. VAS consists of a 10 cm (or 100 mm) long line drawn on a horizontal axis. The distance from the lowest VAS value to the patient's mark is measured in mm (0-100). 0 no pain, 100 mm worst pain

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.

• Western Ontario and McMaster Universities Osteoarthritis Index

  Detection of changes in Western Ontario and McMaster Universities Osteoarthritis Index. It consists of three parts: pain (5 items), stiffness (2 items) and physical function (17 items). It contains 24 items in total. The scoring of the items is based on the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4 which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.

• Lequesne knee index

  Detection of changes in Lequesne knee index. It is a 10-item scale consisting of 3 parts: pain/discomfort, activities of daily living and maximum walking distance.

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.

• The Health Assessment Questionnaire

  Detection of changes in The Health Assessment Questionnaire. The Health Assessment Questionnaire has a total of 20 questions covering 8 areas related to dressing, sitting up, eating, walking, hygiene, reaching, grasping and daily tasks. The test score is calculated by dividing the total score by the number of marked questions. Scoring is between 0 and 3 points. (0: Doing the activity without difficulty, 1: Doing it with some difficulty, 2: Performing it with great difficulty, 3: Not being able to do it at all)

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment

Secondary Outcomes (3)

• Muscle strength

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.

• Proprioception

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment

• Walking parameters

  At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.

Study Arms (3)

Grup 1 quadriceps strengthening exercises

ACTIVE COMPARATOR

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.

Other: Intra-articular hyaluronic acid injection

Grup 2 a home exercise program

ACTIVE COMPARATOR

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.

Other: Intra-articular hyaluronic acid injection

Grup 3 did not receive exercise

PLACEBO COMPARATOR

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.

Other: Intra-articular hyaluronic acid injection

Interventions

Intra-articular hyaluronic acid injection 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 1 quadriceps strengthening exercises; Grup 2 a home exercise program; Grup 3 did not receive exercise

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bilal Uysal

  Balikesir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 8, 2024
• Study Start: March 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: December 29, 2006
• Last Updated: January 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)