Osteoarthritis Knees BothNCT04588558
Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation
A study testing Flywheel exercise, Home exercise and Electrotherapy group in people with Osteoarthritis Knees Both and Pain, Chronic, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of the study is to examine the effect of squat-based exercise approach in individuals with knee osteoarthritis. The aim of this study is to compare effect to three groups (flywheel exercise group, electrotherapy modality group and home exercise group) and also decrease the pain, increase muscle… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Osteoarthritis Knees Both, Pain, Chronic, Walking, Difficulty
- What is being tested?
- Flywheel exercise, Home exercise and Electrotherapy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 2 Apr 2021
- 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
- The age range is between 40-65 years old
- According to ACR criteria, clinically and radiographically, at least one of the knees should be diagnosed with knee OA (within the last 6 months)
- Having findings consistent with Kellgren-Lawrence grade II-III OA on knee radiography
- Pain between 2-7 according to the visual analog scale
Who cannot join
- Acute OA in the knee
- Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries where exercise is contraindicated
- Use of NSAIDs and similar disease modifying drugs (Diacerein, Glucosamine etc.) in the last month
- Having exercised regularly in the last 6 months (more than 1 day a week)
- Having had arthroplasty surgery
- Intra-articular injection (hyaluronic acid / steroid) application in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol University Sefaköy Research and Application Hospital
Istanbul, Küçükçekmece, 34295
About this study
The main purpose of the study is to examine the effect of squat-based exercise approach in individuals with knee osteoarthritis.
The aim of this study is to compare effect to three groups (flywheel exercise group, electrotherapy modality group and home exercise group) and also decrease the pain, increase muscle strength, activation values and increase the functional level of individuals.
Read more
Osteoarthritis is the most common rheumatological disease in the world that primarily results in progressive cartilage destruction. Changes occurring as a result of osteoarthritis are the main cause of disability and are most common in the knee joint.
Osteoarthritis; problems such as pain, tenderness, joint stiffness, joint swelling, movement restriction, joint deformities, loss of muscle strength, decreased functional capacity and impaired quality of life are observed. The daily life activities of individuals with knee osteoarthritis are restricted by the problems of walking up and down stairs, getting out of the chair, standing, squatting, walking.
Improving the symptoms of the disease is an important goal of the rehabilitation process of patients with knee osteoarthritis.
In individuals with knee osteoarthritis, joint structure and deformation in cartilage also show loss of strength with muscles. Strengthening exercises have been used in patients with knee osteoarthritis for a long time. Squat exercise is a type of exercise that is widely used as a strengthening exercise.
Read the detailed description
OA is endemic around the world. About 30.8 million adults in the United States and 300 million people worldwide live with OA. OA is a disease of the entire joint involving structural changes in articular cartilage, subchondral bone, ligaments, capsule, synovial membrane, and periarticular muscles. Clinically, OA is characterized by joint pain, tenderness, limitation of movement, crepitus, effusion and varying degrees of non-systemic inflammation. Pain, stiffness and difficulty in daily life activities due to the negative impact of functional status are among the main symptoms. The knee is the most affected joint.
The aim of this study is to compare effect to three groups (flywheel exercise, electrotherapy modality and home exercise) Flywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training.
Electrophysical agents are used by physiotherapists to treat a wide variety of conditions. Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA
Hypothesis:
- Ho: Three different protocols applied in individuals with knee osteoarthritis have no effect.
- H1-0: It is effective in three different protocols applied in individuals with knee osteoarthritis, but three don't have statistically effect on each other.
- H1-1: Exercise with isoinertial system in individuals with knee osteoarthritis to be more effective than other treatment protocols
- H1-2: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program is more effective than other treatment protocols in individuals with knee osteoarthritis.
- H1-3: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program in individuals with knee osteoarthritis to be more effective than other treatment protocols
Randomization and blinding
After the baseline assessment, the participants were randomized to one of three intervention groups (ratio 1:1:1) using "Research Randomizer," an online randomization web service (https://www.randomizer.org/).
It was planned as a double-blind study without knowing the necessary treatment or experimental condition for both the subject and the researchers.
Sample size
Sample size was determined using an Instat sample size calculator. In the WOMAC sections, the smallest detectable difference and minimal clinically important difference ranged from 0.51 to 1.33 points. This value was used to calculate the sample size (Angst, Aeschlimann, and Stucki, 2001). Investigators included a two sided alpha value of 0.05, a power of 0.9, and a sample size of 21 per group. To allow for dropouts, the sample size was set at 25 per group.
Risk management:
Failure to reach the number of patients, receiving support from other hospitals of the Medipol Hospital Group Unusual increase in the rate of increase of Covid 19 outbreak, (second wave, permanent curfew): Online controlled (tele-rehabilitation) exercises
Research center
Sefaköy Medipol University Hospital Health Practice and Research Center Statistical method (s) to be used
Statistical analysis will be calculated using SPSS for Windows 22 program.
- Being tested
- Flywheel exercise, Home exercise, Electrotherapy group
- Keywords
- Osteoarthritis, Knee, Muscle Activation, Exercise, Pain, Fly wheel
- Medical subject headings
- Chronic Pain, Mobility Limitation, Osteoarthritis, Knee, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flywheel exerciseDevice
Flywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training. Flywheel exercise applied three days a week for 8 weeks
Home exerciseOther
The active ROM exercise was performed via knee in extension to full-flexion, then knee in flexion to full-extension exercises, repeated 10 times. The strengthening exercises consisted of quadriceps strengthening by holding maximal isometric contractions for 10 s and performing 10 repetitions. Stretching targeted the gastrocnemius- soleus and hamstring muscle and was performed by asking the patient to stretch the muscle for 30 s and to complete three repetitions for each muscle group.
Electrotherapy groupDevice
The participants in the electrotherapy group received TENS (Intellect; Chattanooga Group, Hixson, TN), therapeutic ultrasound (Intellect 340 Combo) and exercise. TENS was applied via four electrodes around the knee joint: two on the medial and two on the lateral aspect on either side of the joint line for approximately 20 min. For pain relief, the devices were set to a continuous mode (110 Hz, 50 μ). Electrical pulses were asymmetric and biphasic.
Therapeutic pulsed ultrasound therapy was administered using a 1-MHz frequency, 0.8 W/cm power ultrasound device with a sound-head area of 5 cm2 and effective radiating area of 3.5-5 cm2 . Ultrasound was applied to the medial and lateral parts of the knee in circular movements for a duration of 5 min with the patient in a supine position.
All participants received the same standardized exercise program. The exercises included aerobic, active ROM, strength, and stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Flywheel exercise | Experimental | The term isoinertial is derived from the words iso (same) and inertial (resistance), which define the primary concept of the isoinertial system in a terminology or that expresses both the concentric and eccentric phases of the same muscle contraction. Isoinertial refers to resistance used in exercise training, maintaining a constant inertia throughout the range of motion, a constant resistance in all respects, and facilitating maximum muscle strength. All participants received home exercise for 8 weeks. Receives: Device: Flywheel exercise |
| Electrotherapy modality | Active comparator | Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA.
All participants received home exercise for 8 weeks. Receives: Device: Electrotherapy group |
| Home exercise | Active comparator | All participants received home exercise three times a week for 8 weeks. Home exercises are structured with squats. The exercise program includes stretching exercises and strengthening (isometric and isotonic) exercises. Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The primary outcome measures included the level of function determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) . WOMAC is a specific, valid, reliable criterion for knee osteoarthritis and includes 24 questions under three subheadings: pain, stiffness and physical function. Each question was scored according to the Likert scale as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
Measured: 10 minutes
Secondary outcomes (8)
EMG-BF
EMG-BF (Intelect Advanced Color Combo + EMG, Chattanooga Group, TN, USA) was used to evaluate muscle activation level. The screen scale was used as a visual feedback, as an increased or decreasing signal tone with varying muscle activity as sensory feedback.
The undermentioned muscles will be evaluated in study, Rectus femoris Vastus lateralis Vastus medialis Biceps femoris Gastrocnemius
Measured: 10 minutes
Muscle strength
A dynamometer was used to evaluate muscle strength. Muscle strength was evaluated in the following muscles, each measurement was made three times and the average was taken.
- Iliopsoas M. Gluteus Maximus M. Gluteus Medius M. Quadriceps Femoris Hamstring muscle group M. Gastrosoleus M. Tibialis Anterior
Measured: 10 minutes
Algometer
The instrument that measures sensitivity to pain and gives a numerical value is called an algometer.
In total, application was made at 4 different points. Medial point of heel - Right Medial point of heel - Left Medial point of knee-Right Medial point of knee-Left Measurements were made three times and averaged.
Measured: 5 minutes
Visual Analog Scale (VAS) Evaluation
Purpose and application of the test: The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into numericals. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. Rest, activity and night were evaluated in three different time periods
Measured: 5 minutes
Time up and go test
To determine fall risk and measure the progress of balance, sit to stand and walking.The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down.
Measured: 20 seconds
30 Seconds Sit To Stand Test
The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults.The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.
Measured: 30 Seconds
Step test
The individual is asked to climb and descend 7 times. The total time is recorded.
Measured: 1 minute
goniometer
Lower extremity joints and range of motion were evaluated. Hip Flexion Hip Extension Hip Internal Rotation Hip External Rotation Knee Flexion Knee Extension Ankle Plantar Flexion Ankle Dorsi Flexion
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Sep 2020
- Primary completion5 Feb 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Knees BothStudies 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
- Parallel groups
- Model description
- Squat based exercise will be applied to the first group with isoinertial system. Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program will be applied to the second group, and only squat-based home exercise program will be applied to the third group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588558
- Sponsor's protocol ID
- hazalgenc
- Status last verified
- Apr 2021
- First submitted
- 8 Oct 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of a Structured Squat-based Program in Knee Osteoarthritis Rehabilitation
- ClinicalTrials.gov ID
- NCT04588558
- Acronym / sponsor ID
- hazalgenc
- Keywords
- Osteoarthritis, Knee, Muscle Activation, Exercise, Pain, Fly wheel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 19 Oct 2020 (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.
The main purpose of the study is to examine the effect of squat-based exercise approach in individuals with knee osteoarthritis.
The aim of this study is to compare effect to three groups (flywheel exercise group, electrotherapy modality group and home exercise group) and also decrease the pain, increase muscle strength, activation values and increase the functional level of individuals.
Osteoarthritis is the most common rheumatological disease in the world that primarily results in progressive cartilage destruction. Changes occurring as a result of osteoarthritis are the main cause of disability and are most common in the knee joint.
Osteoarthritis; problems such as pain, tenderness, joint stiffness, joint swelling, movement restriction, joint deformities, loss of muscle strength, decreased functional capacity and impaired quality of life are observed. The daily life activities of individuals with knee osteoarthritis are restricted by the problems of walking up and down stairs, getting out of the chair, standing, squatting, walking.
Improving the symptoms of the disease is an important goal of the rehabilitation process of patients with knee osteoarthritis.
In individuals with knee osteoarthritis, joint structure and deformation in cartilage also show loss of strength with muscles. Strengthening exercises have been used in patients with knee osteoarthritis for a long time. Squat exercise is a type of exercise that is widely used as a strengthening exercise.
Detailed description
OA is endemic around the world. About 30.8 million adults in the United States and 300 million people worldwide live with OA. OA is a disease of the entire joint involving structural changes in articular cartilage, subchondral bone, ligaments, capsule, synovial membrane, and periarticular muscles. Clinically, OA is characterized by joint pain, tenderness, limitation of movement, crepitus, effusion and varying degrees of non-systemic inflammation. Pain, stiffness and difficulty in daily life activities due to the negative impact of functional status are among the main symptoms. The knee is the most affected joint.
The aim of this study is to compare effect to three groups (flywheel exercise, electrotherapy modality and home exercise) Flywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training.
Electrophysical agents are used by physiotherapists to treat a wide variety of conditions. Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA
Hypothesis:
- Ho: Three different protocols applied in individuals with knee osteoarthritis have no effect.
- H1-0: It is effective in three different protocols applied in individuals with knee osteoarthritis, but three don't have statistically effect on each other.
- H1-1: Exercise with isoinertial system in individuals with knee osteoarthritis to be more effective than other treatment protocols
- H1-2: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program is more effective than other treatment protocols in individuals with knee osteoarthritis.
- H1-3: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program in individuals with knee osteoarthritis to be more effective than other treatment protocols
Randomization and blinding
After the baseline assessment, the participants were randomized to one of three intervention groups (ratio 1:1:1) using "Research Randomizer," an online randomization web service (https://www.randomizer.org/).
It was planned as a double-blind study without knowing the necessary treatment or experimental condition for both the subject and the researchers.
Sample size
Sample size was determined using an Instat sample size calculator. In the WOMAC sections, the smallest detectable difference and minimal clinically important difference ranged from 0.51 to 1.33 points. This value was used to calculate the sample size (Angst, Aeschlimann, and Stucki, 2001). Investigators included a two sided alpha value of 0.05, a power of 0.9, and a sample size of 21 per group. To allow for dropouts, the sample size was set at 25 per group.
Risk management:
Failure to reach the number of patients, receiving support from other hospitals of the Medipol Hospital Group Unusual increase in the rate of increase of Covid 19 outbreak, (second wave, permanent curfew): Online controlled (tele-rehabilitation) exercises
Research center
Sefaköy Medipol University Hospital Health Practice and Research Center Statistical method (s) to be used
Statistical analysis will be calculated using SPSS for Windows 22 program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Squat based exercise will be applied to the first group with isoinertial system. Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program will be applied to the second group, and only squat-based home exercise program will be applied to the third group.
| Arm | Type | Receives |
|---|---|---|
| Flywheel exercise | Experimental | Device: Flywheel exerciseThe term isoinertial is derived from the words iso (same) and inertial (resistance), which define the primary concept of the isoinertial system in a terminology or that expresses both the concentric and eccentric phases of the same muscle contraction. Isoinertial refers to resistance used in exercise training, maintaining a constant inertia throughout the range of motion, a constant resistance in all respects, and facilitating maximum muscle strength. All participants received home exercise for 8 weeks. |
| Electrotherapy modality | Active comparator | Device: Electrotherapy groupElectrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA. All participants received home exercise for 8 weeks. |
| Home exercise | Active comparator | Other: Home exerciseAll participants received home exercise three times a week for 8 weeks. Home exercises are structured with squats. The exercise program includes stretching exercises and strengthening (isometric and isotonic) exercises. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The age range is between 40-65 years old
- According to ACR criteria, clinically and radiographically, at least one of the knees should be diagnosed with knee OA (within the last 6 months)
- Having findings consistent with Kellgren-Lawrence grade II-III OA on knee radiography
- Pain between 2-7 according to the visual analog scale
Key exclusion criteria (6 listed)
- Acute OA in the knee
- Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries where exercise is contraindicated
- Use of NSAIDs and similar disease modifying drugs (Diacerein, Glucosamine etc.) in the last month
- Having exercised regularly in the last 6 months (more than 1 day a week)
- Having had arthroplasty surgery
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 |
|---|---|---|
| Flywheel exerciseFlywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training. Flywheel exercise applied three days a week for 8 weeks | Device | Flywheel exercise |
| Home exerciseThe active ROM exercise was performed via knee in extension to full-flexion, then knee in flexion to full-extension exercises, repeated 10 times. The strengthening exercises consisted of quadriceps strengthening by holding maximal isometric contractions for 10 s and performing 10 repetitions. Stretching targeted the gastrocnemius- soleus and hamstring muscle and was performed by asking the patient to stretch the muscle for 30 s and to complete three repetitions for each muscle group. | Other | Home exercise |
| Electrotherapy groupThe participants in the electrotherapy group received TENS (Intellect; Chattanooga Group, Hixson, TN), therapeutic ultrasound (Intellect 340 Combo) and exercise. TENS was applied via four electrodes around the knee joint: two on the medial and two on the lateral aspect on either side of the joint line for approximately 20 min. For pain relief, the devices were set to a continuous mode (110 Hz, 50 μ). Electrical pulses were asymmetric and biphasic. Therapeutic pulsed ultrasound therapy was administered using a 1-MHz frequency, 0.8 W/cm power ultrasound device with a sound-head area of 5 cm2 and effective radiating area of 3.5-5 cm2 . Ultrasound was applied to the medial and lateral parts of the knee in circular movements for a duration of 5 min with the patient in a supine position. All participants received the same standardized exercise program. The exercises included aerobic, active ROM, strength, and stretching exercises | Device | Electrotherapy modality |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 10 minutes
The primary outcome measures included the level of function determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) . WOMAC is a specific, valid, reliable criterion for knee osteoarthritis and includes 24 questions under three subheadings: pain, stiffness and physical function. Each question was scored according to the Likert scale as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
8 secondary outcomes
EMG-BF
Time frame: 10 minutes
Muscle strength
Time frame: 10 minutes
Algometer
Time frame: 5 minutes
Visual Analog Scale (VAS) Evaluation
Time frame: 5 minutes
Time up and go test
Time frame: 20 seconds
30 Seconds Sit To Stand Test
Time frame: 30 Seconds
Step test
Time frame: 1 minute
goniometer
Time frame: 10 minutes
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 12 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flywheel exercise, Home exercise and Electrotherapy group in people with Osteoarthritis Knees Both and Pain, Chronic, run by Istanbul Medipol University Hospital 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 6 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 12 Apr 2021. 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. 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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 10 minutes). 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 12 Apr 2021.