Knee OsteoarthritisNCT05211544
The Effect of Physical Therapy Modalities and Kinesio Taping in Patients With Knee Osteoarthritis
A study testing physical therapy modalities and exercise, kinesio taping and exercise and exercise in people with Knee Osteoarthritis and Knee Pain Chronic, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the USA alone.(1-2) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- physical therapy modalities and exercise, kinesio taping and exercise and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2022to 21 Apr 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 50 ages Stage 2-3 osteoarthritis according to Kellgren Lawrence lectures
Who cannot join
- Presence of acute infection The patient has a history of knee surgery Presence of rheumatological disease History of malignancy Major knee trauma Presence of crystal arthropathy Presence of acute trauma/fracture History of avascular necrosis The presence of contracture in the knee Using analgesic or anti-inflammatory drugs in the last 1 week Using oral or intramuscular corticosteroids in the last 3 months Intra-articular injection of the knee in the last 6 months Receiving physical therapy modalities from the knee area in the last 1 year Diseases such as dementia that may cause loss of cognitive functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physical Therapy Modalities and Kinesio Taping on Kinesiophobia and Thickness of the Quadriceps Muscle in Patients With Knee Osteoarthritis
Osteoarthritis (OA) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the USA alone.(1-2)
Read the detailed description
Osteoarthritis (OA) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the USA alone.(1-2) The primary risk factor for OA is age however ; It is a multifactorial disease, including injury and genetic mutations.(3-6) The knee is the most commonly involved joint in OA. In the United States, about 14 million people is presumed to have symptomatic knee osteoarthritis. Typical OA manifests as joint pain which is exacerbated by activity and relieved by rest. In advanced stage, pain at rest and at night and morning stiffness lasting no more than 20-30 minutes can be seen. (2) The diagnosis is based on a detailed anamnesis, a complete physical examination, and diagnostic imaging. Imaging findings include joint space narrowing, osteophytes, pseudocyst and subchondral sclerosis in the subchondral bone.(9) Pharmacological and non-pharmacological treatments are applied. Exercise, conventional physical therapy ( hotpack, therapeutic ultrasound, tens) and kinesioband are some of the non-pharmacological treatments.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Being tested
- physical therapy modalities and exercise, kinesio taping and exercise, exercise
- Keywords
- kinesio tape, kinesiophobia, therapeutic ultrasound, exercise, ultrasound
- Medical subject headings
- Osteoarthritis, Knee, Kinesiophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy modalities and exerciseOther
30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive physical therapy modalities during two weeks for ten times. physical therapy modalities include hotpack, tens, ultrasound.
kinesio taping and exerciseOther
30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive kinesio tape for their knee three times a week for two week
exerciseOther
30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention group 1 | Active comparator | 30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive physical therapy modalities during two weeks for ten times. physical therapy modalities include hotpack, tens, ultrasound. Receives: Other: physical therapy modalities and exercise |
| intervention group 2 | Active comparator | 30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive kinesio tape for their knee three times a week for two week Receives: Other: kinesio taping and exercise |
| control group | Active comparator | 30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
tampa scala of kinesiophobia
It is developed to measure the fear of movement and reinjury. The scale will be measured at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment
Measured: four weeks
thickness of the quadriceps muscle
Muscle hypertrophy is expected with regular isometric and isotonic exercises. In order to investigate the muscle effect of the treatments, the thickness of the quadriceps muscle will be measured with an ultrasound device. Measurement will be made at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment
Measured: four weeks
Secondary outcomes (2)
western ontario and mcmaster universities osteoarthritis index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. Measurement will be made at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment
Measured: four weeks
visual analog scale
The visual analog scale (VAS) is used to measure pain. The patient indicates where his/her condition is appropriate above a 100 mm line. For example, for pain, there is no pain at one end and very severe pain at the other end, and the patient marks his/her condition on this line. Measurement will be made at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start21 Jan 2022 (estimated)
- Primary completion21 Mar 2022 (estimated)
- Study completion21 Apr 2022 (estimated)
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 Abant Izzet Baysal 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three group 1. exercise group 2. exercise and kinesiotape 3. exercise and physical therapy modalities
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe özdemirkan, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211544
- Sponsor's protocol ID
- ao...1
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- 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 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Therapy Modalities and Kinesio Taping on Kinesiophobia and Thickness of the Quadriceps Muscle in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05211544
- Acronym / sponsor ID
- ao...1
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Keywords
- kinesio tape, kinesiophobia, therapeutic ultrasound, exercise, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 21 Jan 2022 (estimated)
- Primary completion
- 21 Mar 2022 (estimated)
- Study completion
- 21 Apr 2022 (estimated)
- First posted
- 27 Jan 2022 (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) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the USA alone.(1-2)
Detailed description
Osteoarthritis (OA) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the USA alone.(1-2) The primary risk factor for OA is age however ; It is a multifactorial disease, including injury and genetic mutations.(3-6) The knee is the most commonly involved joint in OA. In the United States, about 14 million people is presumed to have symptomatic knee osteoarthritis. Typical OA manifests as joint pain which is exacerbated by activity and relieved by rest. In advanced stage, pain at rest and at night and morning stiffness lasting no more than 20-30 minutes can be seen. (2) The diagnosis is based on a detailed anamnesis, a complete physical examination, and diagnostic imaging. Imaging findings include joint space narrowing, osteophytes, pseudocyst and subchondral sclerosis in the subchondral bone.(9) Pharmacological and non-pharmacological treatments are applied. Exercise, conventional physical therapy ( hotpack, therapeutic ultrasound, tens) and kinesioband are some of the non-pharmacological treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three group 1. exercise group 2. exercise and kinesiotape 3. exercise and physical therapy modalities
| Arm | Type | Receives |
|---|---|---|
| intervention group 1 | Active comparator | Other: physical therapy modalities and exercise30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive physical therapy modalities during two weeks for ten times. physical therapy modalities include hotpack, tens, ultrasound. |
| intervention group 2 | Active comparator | Other: kinesio taping and exercise30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive kinesio tape for their knee three times a week for two week |
| control group | Active comparator | Other: exercise30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 50 ages Stage 2-3 osteoarthritis according to Kellgren Lawrence lectures
Key exclusion criteria (1 listed)
- Presence of acute infection The patient has a history of knee surgery Presence of rheumatological disease History of malignancy Major knee trauma Presence of crystal arthropathy Presence of acute trauma/fracture History of avascular necrosis The presence of contracture in the knee Using analgesic or anti-inflammatory drugs in the last 1 week Using oral or intramuscular corticosteroids in the last 3 months Intra-articular injection of the knee in the last 6 months Receiving physical therapy modalities from the knee area in the last 1 year Diseases such as dementia that may cause loss of cognitive functions
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 |
|---|---|---|
| physical therapy modalities and exercise30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive physical therapy modalities during two weeks for ten times. physical therapy modalities include hotpack, tens, ultrasound. | Other | intervention group 1 |
| kinesio taping and exercise30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. Also they will receive kinesio tape for their knee three times a week for two week | Other | intervention group 2 |
| exercise30 patient with osteoartritis will do knee strengthening exercise for half an hour a day,3 days a week. This exercise program will continue for 4 weeks. | Other | control group |
Primary outcome
tampa scala of kinesiophobia
Time frame: four weeks
It is developed to measure the fear of movement and reinjury. The scale will be measured at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment
thickness of the quadriceps muscle
Time frame: four weeks
Muscle hypertrophy is expected with regular isometric and isotonic exercises. In order to investigate the muscle effect of the treatments, the thickness of the quadriceps muscle will be measured with an ultrasound device. Measurement will be made at the beginning of the study and at the end of the fourth week, which corresponds to the end of the treatment
2 secondary outcomes
western ontario and mcmaster universities osteoarthritis index
Time frame: four weeks
visual analog scale
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- 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.
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 physical therapy modalities and exercise, kinesio taping and exercise and exercise in people with Knee Osteoarthritis and Knee Pain Chronic, run by Abant Izzet Baysal 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2022. 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?
Results are not available in the source record.
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?
tampa scala of kinesiophobia (time frame: four 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 27 Jan 2022.