Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06196021
Other study ID # Knee Osteoarthritis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2006
Est. completion date December 29, 2006

Study information

Verified date December 2023
Source Balikesir University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 29, 2006
Est. primary completion date September 1, 2006
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Turkey Balikesir University Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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 Muscle strength Detection of changes in muscle strength. Muscle strength was measured with a Biodex System 3 Pro Multijoint System® isokinetic dynamometer (Biodex Medical Inc, Shirley / NY, USA). At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Secondary Proprioception Detection of changes in proprioception. Proprioception was measured with a Biodex System 3 Pro Multijoint System® isokinetic dynamometer (Biodex Medical Inc, Shirley / NY, USA). At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
Secondary Walking parameters Evaluate their effects on walking parameters. The walking parameters of the patients were obtained with a 3-dimensional motion analysis system consisting of 6 high-speed (100 ps) cameras (Elite System, BTS S.p.A, Milan, Italy). At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A