Knee OsteoarthritisNCT06196021
Effects of Hyaluronic Acid Injection and Exercise Treatments in Knee Osteoarthritis
A study testing Intra-articular hyaluronic acid injection in people with Knee Osteoarthritis, run by Balikesir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra-articular hyaluronic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2006to 29 Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Patients with bleeding disorders
- Malignancy
- Patients who are pregnant
- Patients who are with diabetes
- Patients who are with active vestibular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hyaluronic Acid Injection and Exercise Therapies on Proprioception, Gait Analysis and Quality of Life in Patients With Knee Osteoarthritis
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.
Read the 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
- Being tested
- Intra-articular hyaluronic acid injection
- Keywords
- Knee Osteoarthritis, Hyaluronic Acid Injection, Exercise, Gait Analysis, Proprioception
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular hyaluronic acid injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Intra-articular hyaluronic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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)
Measured: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
Secondary outcomes (3)
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).
Measured: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
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).
Measured: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
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).
Measured: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Mar 2006
- Primary completion1 Sep 2006
- Study completion29 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Uysal, Balikesir University
- Investigators
- Bilal Uysal, Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196021
- Sponsor's protocol ID
- Knee Osteoarthritis
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyaluronic Acid Injection and Exercise Therapies on Proprioception, Gait Analysis and Quality of Life in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06196021
- Acronym / sponsor ID
- Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Hyaluronic Acid Injection, Exercise, Gait Analysis, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Mar 2006 (actual)
- Primary completion
- 1 Sep 2006 (actual)
- Study completion
- 29 Dec 2006 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grup 1 quadriceps strengthening exercises | Active comparator | Other: Intra-articular hyaluronic acid injectionThe 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. |
| Grup 2 a home exercise program | Active comparator | Other: Intra-articular hyaluronic acid injectionThe 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. |
| Grup 3 did not receive exercise | Placebo comparator | Other: Intra-articular hyaluronic acid injectionThe 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular hyaluronic acid injectionHyaluronic 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. | Other | Grup 1 quadriceps strengthening exercises, Grup 2 a home exercise program, Grup 3 did not receive exercise |
Primary outcome
Visual Analogue Scale-pain,
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
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
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
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).
Lequesne knee index
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
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.
The Health Assessment Questionnaire
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
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)
3 secondary outcomes
Muscle strength
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Proprioception
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
Walking parameters
Time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilal Uysal principal investigator
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular hyaluronic acid injection in people with Knee Osteoarthritis, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale-pain, (time frame: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.