NCT06196021|Completed
Loading search results
Sponsor study identifier
interventional
54
1 country
1
Study Start
March 1, 2006
Actual (reported)Primary Completion
September 1, 2006
Actual (reported)Study Completion
December 29, 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 29, 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2006
Actual (reported)September 1, 2006
Actual (reported)December 29, 2006
Actual (reported)December 8, 2023
Actual (reported)January 8, 2024
Actual (reported)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)
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.
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Balikesir University
Balıkesir, 10145, Turkey (Türkiye)
Bilal Uysal
Balikesir University
54 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2023
First Posted
January 8, 2024
Study Start
March 1, 2006
Actual (reported)Knee Osteoarthritis and Rehabilitation
At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
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.
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2006
Actual (reported)Study Completion
December 29, 2006
Actual (reported)Last Updated
January 8, 2024
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: