Osteo Arthritis KneeNCT05089253
Effect of Physical Therapy Modalities in Osteoarthritis
A study testing Dry Needling and Kinesio tapping in people with Osteo Arthritis Knee and Quadriceps Muscle Atrophy, run by Majmaah University at 1 site in India.
Trial summary
The purpose of this study was to find the most effective treatment out of both techniques; Dry needling and Kinesio Taping for treating knee osteoarthritis (OA) in terms of pain, strength, and balance Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Quadriceps Muscle Atrophy
- What is being tested?
- Dry Needling and Kinesio tapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- 6 Oct 2021to 21 Mar 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with osteoarthritis.
Who cannot join
- Surgical procedures in the lower extremity in the last 6 months
- neurological disorders
- skin allergy
- patient is under pain medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dry Needling and Kinesio Taping On Pain Strength and Balance of Quadriceps Muscle in Knee Osteoarthritis. A Randomized Controlled Trial
The purpose of this study was to find the most effective treatment out of both techniques; Dry needling and Kinesio Taping for treating knee osteoarthritis (OA) in terms of pain, strength, and balance
Read the detailed description
Knee osteoarthritis is also associated with a 50%-60% reduction in maximum quadriceps torque, possibly resulting from disuse atrophy and atherogenic inhibition.
Kinesio taping is a term that comes from the field of kinesiology, because the application of the tape allows the body to move normally, and reacts to fascia via biomechanical or proprioceptive mechanisms. Kinesio tape is an elastic therapeutic tape that finds its application as an adjunct to professional activities in healthcare, rehabilitation, prevention, and sports. In circulatory pathologies, Kinesio tape has the function to promote the drainage of excess fluid, activating a lymphatic drainage response. Kinesio tape promotes better blood circulation and lymph flow in the treated area, and this principle can be used to drain the swelling in trauma and bruises to speed up the process of redistribution of the hematoma. Kinesio tape application decreases the surplus heat via friction reduction resulting in lifting the skin. It also has a good stabilizing effect. Kinesio tape was also used for treating sports and orthopedic injuries, and a variety of musculoskeletal disorders like osteoarthritis. For example, the research of Murray H. has shown an increase in the electromyographic quadriceps muscular activity with Kinesio tape application, applied by patients after ACL repair in the postoperative phase.
Dry is a specific technique for the treatment of functional disorders of the skeleton muscles, fascia, and connective tissue. It can also be used to reduce pain, restore function and reduce structural defects in muscles and joints, the dry needling treatment approaches are based on three models (including models of radiculopathy, spinal sensitization, and myofascial trigger point model). The dry needling technique can be divided into superficial and deep techniques.
Conservative treatment is advocated in patients with mild to moderate osteoarthritis of the knee. Because muscles weakness is associated with pain and physical dysfunction and influences the progression of disease in patients with knee osteoarthritis. Muscle strengthening is a key component in knee osteoarthritis Therefore, local strengthening exercise is prescribed more frequently than general exercise. A growing body of evidence shows that exercise improves knee joint function and decreases symptoms.
- Conditions
- Osteo Arthritis Knee, Quadriceps Muscle Atrophy
- Being tested
- Dry Needling, Kinesio tapping
- Keywords
- dry needling, kinesio tapping, osteoarthritis, Quadriceps
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
The subject will be in the supine position and receive dry needling. The first point will be at the medial femoral condyle of the knee joint line in vastus medialis muscles. The second point will be at the lateral femoral condyle of the knee joint line in vastus lateralis muscles. The third point will be above the base of the patella in the rectus femoris muscle. The fourth point will be 2cm above the third point in rectus femoris muscles. These four points were the most common places of trigger point at quadriceps muscles. Dry needling is affected on A-delta fibers. Therefore when superficial dry needling with a noxious stimulation leads to stimulation on A-delta fibers, the excitation remains almost 72 hours and gradually decreases.
The standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks.
Kinesio tappingOther
The subject will be in the supine position and receive Kinesio taping. The Kinesio tape application with no tension one Y strip with a length of 20 cm, an anchor of 2 cm.
The Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Active comparator | The standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks. Receives: Other: Kinesio tapping |
| kinesio taping | Active comparator | The Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks Receives: Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario McMasters Universities Osteoarthritis index
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The test questions are scored on a scale of 0-4 which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Higher scores on the Western Ontario McMasters Universities Osteoarthritis index indicate worse pain, stiffness, and functional limitations.
Measured: 4 weeks
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: 4 weeks
Visual Analogue scale
A Visual Analogue Scale is a measurement instrument that attempts to measure a characteristic or attitude that is thought to range across a range of values and cannot be easily measured directly. It is frequently used in epidemiologic and clinical research to assess the severity or frequency of different symptoms. For example, a patient's level of pain ranges from none to severe. From the patient's point of view, this spectrum appears continuous; their pain does not appear to have discrete jumps, as a categorization of none, mild, moderate, and severe would imply. The VAS was created in order to capture the concept of an underlying continuum. Pain intensity on the from 0 to 100. 0 represents no pain and 100 represents severe pain
Measured: 4 weeks
Manual Muscle Testing
This method is also known as the Oxford scale involves testing key muscles in the patient's upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5. In this research, the quadriceps muscle will be assessed manually by the examiner. o means no power and 5 means good muscle strength.
- No movement.
- Flicker of contraction.
- Full range of motion in the elimination of gravity.
- Full range of motion against gravity.
- Full range of motion against gravity with mild resistance.
- Full range of motion against gravity with maximum resistance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start6 Oct 2021
- Primary completion1 Feb 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Mohammad Miraj, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089253
- Sponsor's protocol ID
- AIHMS New Delhi
- Status last verified
- Mar 2022
- First submitted
- 10 Oct 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dry Needling and Kinesio Taping On Pain Strength and Balance of Quadriceps Muscle in Knee Osteoarthritis. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05089253
- Acronym / sponsor ID
- AIHMS New Delhi
- Conditions
- Osteo Arthritis Knee, Quadriceps Muscle Atrophy
- Keywords
- dry needling, kinesio tapping, osteoarthritis, Quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 22 Oct 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.
The purpose of this study was to find the most effective treatment out of both techniques; Dry needling and Kinesio Taping for treating knee osteoarthritis (OA) in terms of pain, strength, and balance
Detailed description
Knee osteoarthritis is also associated with a 50%-60% reduction in maximum quadriceps torque, possibly resulting from disuse atrophy and atherogenic inhibition.
Kinesio taping is a term that comes from the field of kinesiology, because the application of the tape allows the body to move normally, and reacts to fascia via biomechanical or proprioceptive mechanisms. Kinesio tape is an elastic therapeutic tape that finds its application as an adjunct to professional activities in healthcare, rehabilitation, prevention, and sports. In circulatory pathologies, Kinesio tape has the function to promote the drainage of excess fluid, activating a lymphatic drainage response. Kinesio tape promotes better blood circulation and lymph flow in the treated area, and this principle can be used to drain the swelling in trauma and bruises to speed up the process of redistribution of the hematoma. Kinesio tape application decreases the surplus heat via friction reduction resulting in lifting the skin. It also has a good stabilizing effect. Kinesio tape was also used for treating sports and orthopedic injuries, and a variety of musculoskeletal disorders like osteoarthritis. For example, the research of Murray H. has shown an increase in the electromyographic quadriceps muscular activity with Kinesio tape application, applied by patients after ACL repair in the postoperative phase.
Dry is a specific technique for the treatment of functional disorders of the skeleton muscles, fascia, and connective tissue. It can also be used to reduce pain, restore function and reduce structural defects in muscles and joints, the dry needling treatment approaches are based on three models (including models of radiculopathy, spinal sensitization, and myofascial trigger point model). The dry needling technique can be divided into superficial and deep techniques.
Conservative treatment is advocated in patients with mild to moderate osteoarthritis of the knee. Because muscles weakness is associated with pain and physical dysfunction and influences the progression of disease in patients with knee osteoarthritis. Muscle strengthening is a key component in knee osteoarthritis Therefore, local strengthening exercise is prescribed more frequently than general exercise. A growing body of evidence shows that exercise improves knee joint function and decreases symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Active comparator | Other: Kinesio tappingThe standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks. |
| kinesio taping | Active comparator | Other: Dry NeedlingThe Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with osteoarthritis.
Key exclusion criteria (4 listed)
- Surgical procedures in the lower extremity in the last 6 months
- neurological disorders
- skin allergy
- patient is under pain medications.
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 |
|---|---|---|
| Dry NeedlingThe subject will be in the supine position and receive dry needling. The first point will be at the medial femoral condyle of the knee joint line in vastus medialis muscles. The second point will be at the lateral femoral condyle of the knee joint line in vastus lateralis muscles. The third point will be above the base of the patella in the rectus femoris muscle. The fourth point will be 2cm above the third point in rectus femoris muscles. These four points were the most common places of trigger point at quadriceps muscles. Dry needling is affected on A-delta fibers. Therefore when superficial dry needling with a noxious stimulation leads to stimulation on A-delta fibers, the excitation remains almost 72 hours and gradually decreases. The standard 9- point dry needling technique will be applied for 20 minutes per session 3 times a week for 4 weeks. | Other | kinesio taping |
| Kinesio tappingThe subject will be in the supine position and receive Kinesio taping. The Kinesio tape application with no tension one Y strip with a length of 20 cm, an anchor of 2 cm. The Kinesio tape will be applied to the participants in supine with the knee in 90 flexions. Two Y-shaped tapes are applied above and below the patella. The tape will be removed after 48 hours after application. The Kinesio tape will be applied 3 times a week for 4 weeks. | Other | Dry needling |
Primary outcome
Western Ontario McMasters Universities Osteoarthritis index
Time frame: 4 weeks
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The test questions are scored on a scale of 0-4 which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the Western Ontario McMasters Universities Osteoarthritis index indicate worse pain, stiffness, and functional limitations.
Berg Balance Scale
Time frame: 4 weeks
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Visual Analogue scale
Time frame: 4 weeks
A Visual Analogue Scale is a measurement instrument that attempts to measure a characteristic or attitude that is thought to range across a range of values and cannot be easily measured directly. It is frequently used in epidemiologic and clinical research to assess the severity or frequency of different symptoms. For example, a patient's level of pain ranges from none to severe. From the patient's point of view, this spectrum appears continuous; their pain does not appear to have discrete jumps, as a categorization of none, mild, moderate, and severe would imply. The VAS was created in order to capture the concept of an underlying continuum. Pain intensity on the from 0 to 100. 0 represents no pain and 100 represents severe pain
Manual Muscle Testing
Time frame: 4 weeks
This method is also known as the Oxford scale involves testing key muscles in the patient's upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5. In this research, the quadriceps muscle will be assessed manually by the examiner. o means no power and 5 means good muscle strength. 0. No movement. 1. Flicker of contraction. 2. Full range of motion in the elimination of gravity. 3. Full range of motion against gravity. 4. Full range of motion against gravity with mild resistance. 5. Full range of motion against gravity with maximum resistance.
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 31 Mar 2022.
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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 Dry Needling and Kinesio tapping in people with Osteo Arthritis Knee and Quadriceps Muscle Atrophy, run by Majmaah University at 1 site in India.
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 4 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 31 Mar 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 India. 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 McMasters Universities Osteoarthritis index (time frame: 4 weeks). 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 31 Mar 2022.