Knee OsteoarthritisNCT05033977
Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection
A study testing Exercise (center-based) and Exercise (home-based) in people with Knee Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of motion, instability and effusion in the joint. Moreover, no study has investigated the effect of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same patient with bilateral knee OA. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise (center-based) and Exercise (home-based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Apr 2020
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with knee osteoarthritis
- Patients with PRP injections
Who cannot join
- have any neurologic disease
- have any oncologic disease
- have any other intraarticular injection last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
Official title: Investigating of Difference Between Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection in Women With Knee Osteoarthritis
Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of motion, instability and effusion in the joint. Moreover, no study has investigated the effect of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same patient with bilateral knee OA. The purpose of this study was to compare the effectiveness of supervised physiotherapy and home exercises after PRP injection in patients with knee OA. The investigator hypothesized that the supervised physiotherapy program would be more effective in decreasing pain and improving muscle strength, physical function, and quality of life than home exercises following PRP injection in patients with knee OA. A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.
Read the detailed description
A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.
Pain Measurement Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity.
Muscle Strength Measurement Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement. According to this technique, the evaluator gradually overcomes the muscle strength and stops when the joint gives way. The quadriceps muscle strength was measured in a sitting position (Hip 90° flexion, knee extended) with hands crossed across the chest. The hand-held dynamometer was positioned on the anterior surface of the lower leg proximal to the ankle during test. Hamstring muscle group measurement was carried out on prone position (Hip neutral position, knee flexion 90°). The hand-held dynamometer was positioned on the posterior surface of the lower leg proximal to the ankle during test. The HipSIT evaluates the abductor, external rotator and extensor muscles of the hip together. This test was performed in a side-lying position (Hips 45° flexion, knees 90° flexion, heels in contact with the limb tested superior to opposing limb as 20° abduction). The hand-held dynamometer was placed on laterally positioned 5 cm above the knee joint interline during test. Each measurement for each muscle was performed 3 times at 30 sec intervals and the higher value was recorded. There was also a minute interval between muscle groups measurements.
Functional Status The Western Ontario and McMaster Universities (WOMAC) index is a disease specific self-administered test for OA to assess functions of the affected joints. It consists of 24 questions (three subscale; pain (5 questions), stiffness (2 questions) and daily activities (17 questions).
Interventions Each subject was informed about knee OA and daily activities that negatively affect the knee OA. They were also asked to use cold press 3 times (10-15 min) a day for 6 weeks. Supervised physiotherapy group performed exercises 3 times a week for 6 weeks under supervision of a physiotherapist after the first evaluation. The subjects in home exercise group were taught exercises and they were informed to do exercises 3 times a week for 6 weeks. Home exercise group was telephoned to motivate them to do exercise or to find out if they have any problem about the exercises once a week for 6 weeks. The exercise programs for each group consisted of these parts: warm up, strengthening, balance and cool down period. The standard exercises were performed by all of the subjects in each group in order to standardize the exercise procedure. We used OMNI Resistance Exercise Scale for perceived effort to standardize elastic-band (Thera-Band; The Hygenic Corporation, Akron, OH) resistance among subjects. Subjects were asked to do 3 repetitions for each exercise starting with lowest resistance elastic band, and the resistance of the elastic band was increased until it reached 5 on the 11-point scale to determine the appropriate elastic band. Second measurements were performed at the end of 6 weeks, the day of routine doctor control for PRP injection. All assessments were performed by the same physiotherapist.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise (center-based), Exercise (home-based)
- Keywords
- Knee, Osteoarthritis, Exercise, Platelet rich plasma, muscle strength
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise (center-based)Other
Exercise therapy with a physical therapist in a clinic.
Exercise (home-based)Other
Patients did exercises at home every day and 3 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Center-based Exercise | Experimental | patients did exercises with a physical therapist in a clinic 3 days and 45 minute in a week for 6 weeks.
The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings. Receives: Other: Exercise (center-based) |
| Home-based exercise | Experimental | Patients did exercises at home every day and 3 times per day. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings. Receives: Other: Exercise (home-based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel analogue scale
Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity
Measured: 6 weeks
Muscle Strenght
Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement.
Measured: 6 weeks
Secondary outcomes (5)
Physical Function
A 30-sec chair stand test and stair climb test were used to assess physical performance. The subjects were asked to stand up from a chair (height: 43cm) and sit down in 30 sec with their arms folded across the chest during the 30-sec chair stand test. The number of the repetitions were recorded. The subjects were asked to ascend and descend 10 steps (step height 20 cm) at a safe and comfortable pace during the stair climb test. The time (sec) of stair ascend and descend were recorded separately.
Measured: 6 weeks
Knee Function
The Western Ontario and McMaster Universities (WOMAC) index is a disease specific self-administered test for OA to assess functions of the affected joints. It consists of 24 questions (three subscale; pain (5 questions), stiffness (2 questions) and daily activities (17 questions)
Measured: 6 weeks
Weight
participants' weight was measured with a digital scale
Measured: 6 weeks
Height
participants' height was measured with a tape measure
Measured: 6 weeks
Body mass index (BMI)
Body Mass Index was calculated using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Apr 2020
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- supervised exercise group home exercise group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE GUNEY, Hacettepe University
- Investigators
- Hande Güney Deniz, Assoc.,Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033977
- Sponsor's protocol ID
- GO 2021/049
- Status last verified
- Aug 2021
- First submitted
- 31 May 2021
- Last updated
- 5 Sep 2021
- Results posted
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating of Difference Between Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection in Women With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05033977
- Acronym / sponsor ID
- GO 2021/049
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Exercise, Platelet rich plasma, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 5 Sep 2021 (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.
Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of motion, instability and effusion in the joint. Moreover, no study has investigated the effect of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same patient with bilateral knee OA. The purpose of this study was to compare the effectiveness of supervised physiotherapy and home exercises after PRP injection in patients with knee OA. The investigator hypothesized that the supervised physiotherapy program would be more effective in decreasing pain and improving muscle strength, physical function, and quality of life than home exercises following PRP injection in patients with knee OA. A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.
Detailed description
A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.
Pain Measurement Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity.
Muscle Strength Measurement Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement. According to this technique, the evaluator gradually overcomes the muscle strength and stops when the joint gives way. The quadriceps muscle strength was measured in a sitting position (Hip 90° flexion, knee extended) with hands crossed across the chest. The hand-held dynamometer was positioned on the anterior surface of the lower leg proximal to the ankle during test. Hamstring muscle group measurement was carried out on prone position (Hip neutral position, knee flexion 90°). The hand-held dynamometer was positioned on the posterior surface of the lower leg proximal to the ankle during test. The HipSIT evaluates the abductor, external rotator and extensor muscles of the hip together. This test was performed in a side-lying position (Hips 45° flexion, knees 90° flexion, heels in contact with the limb tested superior to opposing limb as 20° abduction). The hand-held dynamometer was placed on laterally positioned 5 cm above the knee joint interline during test. Each measurement for each muscle was performed 3 times at 30 sec intervals and the higher value was recorded. There was also a minute interval between muscle groups measurements.
Functional Status The Western Ontario and McMaster Universities (WOMAC) index is a disease specific self-administered test for OA to assess functions of the affected joints. It consists of 24 questions (three subscale; pain (5 questions), stiffness (2 questions) and daily activities (17 questions).
Interventions Each subject was informed about knee OA and daily activities that negatively affect the knee OA. They were also asked to use cold press 3 times (10-15 min) a day for 6 weeks. Supervised physiotherapy group performed exercises 3 times a week for 6 weeks under supervision of a physiotherapist after the first evaluation. The subjects in home exercise group were taught exercises and they were informed to do exercises 3 times a week for 6 weeks. Home exercise group was telephoned to motivate them to do exercise or to find out if they have any problem about the exercises once a week for 6 weeks. The exercise programs for each group consisted of these parts: warm up, strengthening, balance and cool down period. The standard exercises were performed by all of the subjects in each group in order to standardize the exercise procedure. We used OMNI Resistance Exercise Scale for perceived effort to standardize elastic-band (Thera-Band; The Hygenic Corporation, Akron, OH) resistance among subjects. Subjects were asked to do 3 repetitions for each exercise starting with lowest resistance elastic band, and the resistance of the elastic band was increased until it reached 5 on the 11-point scale to determine the appropriate elastic band. Second measurements were performed at the end of 6 weeks, the day of routine doctor control for PRP injection. All assessments were performed by the same physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- supervised exercise group home exercise group
| Arm | Type | Receives |
|---|---|---|
| Center-based Exercise | Experimental | Other: Exercise (center-based)patients did exercises with a physical therapist in a clinic 3 days and 45 minute in a week for 6 weeks. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings. |
| Home-based exercise | Experimental | Other: Exercise (home-based)Patients did exercises at home every day and 3 times per day. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with knee osteoarthritis
- Patients with PRP injections
Key exclusion criteria (3 listed)
- have any neurologic disease
- have any oncologic disease
- have any other intraarticular injection last 6 months
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 |
|---|---|---|
| Exercise (center-based)Exercise therapy with a physical therapist in a clinic. | Other | Center-based Exercise |
| Exercise (home-based)Patients did exercises at home every day and 3 times per day. | Other | Home-based exercise |
Primary outcome
Visuel analogue scale
Time frame: 6 weeks
Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity
Muscle Strenght
Time frame: 6 weeks
Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement.
5 secondary outcomes
Physical Function
Time frame: 6 weeks
Knee Function
Time frame: 6 weeks
Weight
Time frame: 6 weeks
Height
Time frame: 6 weeks
Body mass index (BMI)
Time frame: 6 weeks
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 5 Sep 2021.
- 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.
Hande Güney Deniz, Assoc.,Prof study director
Hacettepe 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 Exercise (center-based) and Exercise (home-based) in people with Knee Osteoarthritis, run by Hacettepe 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 2 inclusion and 3 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 5 Sep 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?
Visuel analogue scale (time frame: 6 weeks). The study lists 2 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 5 Sep 2021.