Meniscus TearsNCT06637670
Kinesiological Taping in Individuals With Meniscus Injury
A study testing Kinesiology taping in people with Meniscus Tears, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore how kinesiology taping affects people with mild to moderate meniscus injuries (grades I/II), focusing on pain, movement fears, muscle strength, balance, joint movement, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Tears
- What is being tested?
- Kinesiology taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with meniscus grade I/II,
- Who agreed to participate in the study
- Signed the voluntary consent form
Who cannot join
- Pregnant individuals
- Individuals with additional knee injuries (e.g., ligament tears) or chronic conditions affecting the knee (e.g., arthritis).
- Patients with grade III meniscus tears or more severe injuries.
- Who had knee surgery in the last 6 months.
- Patients with skin conditions or allergies to adhesive materials or kinesiology tape.
- Individuals with neurological conditions such as multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Kinesiological Taping on Pain, Quality of Life and Musculoskeletal System Parameters in Individuals With Meniscus Injury: A Randomized, Placebo-Controlled Study
This study aims to explore how kinesiology taping affects people with mild to moderate meniscus injuries (grades I/II), focusing on pain, movement fears, muscle strength, balance, joint movement, and quality of life.
Two groups will be involved: one will receive kinesiology taping on the thigh muscle with some tension, while the other will receive a placebo tape with no tension. Researchers will measure various factors, including pain and muscle strength, both before and 48-72 hours after taping.
Read the detailed description
This study aims to understand the short-term (acute) effects of kinesiology taping on people with mild to moderate meniscus injuries (grade I/II). These injuries, affecting the cartilage in the knee, can cause pain, reduced mobility, and fear of movement. Kinesiology taping, a popular therapy, involves applying elastic tape to support muscles and joints. This research looked at whether taping could improve pain, muscle strength, movement, balance, and quality of life in patients with these knee injuries.
Study Design The study will use a randomized, placebo-controlled, and double-blinded design, meaning that patients were randomly assigned to two groups, and neither the patients nor the researchers knew which group each person was in during the treatment.
Experimental Group: will receive kinesiology taping on the quadriceps muscle (the large muscle at the front of the thigh) using a 'Y-shaped' technique with moderate tension (25-50% stretch).
Control Group: will receive a placebo tape applied without tension and placed in a different direction.
Measurements
To evaluate the effects of taping, several aspects will be measured both before the tape was applied and 48-72 hours later:
Pain levels Fear of movement (kinesiophobia) Muscle strength (ability to extend the knee) Proprioception (awareness of limb position and force applied) Joint range of motion (how much the knee can bend and straighten) Joint position sense (accuracy in detecting knee position with eyes closed) Quality of life, using a questionnaire (SF-36) that assesses various aspects like physical function and energy levels.
- Conditions
- Meniscus Tears
- Being tested
- Kinesiology taping, Placebo taping
- Keywords
- kinesiology taping, pain, quality of life, meniscus injury
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology tapingOther
'Y shaped' kinesiology taping was applied on quadriceps femoris muscle, based on facilitation technique with 25-50% stretching.
Placebo tapingOther
A tape without tension was applied perpendicular on the quadriceps femoris muscle.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | This group was applied 'Y shaped' kinesiology taping on quadriceps femoris muscle, based on facilitation technique with 25-50% stretching. Receives: Other: Kinesiology taping |
| The placebo group | Placebo comparator | This group was applied a tape without tension, perpendicular to the quadriceps femoris muscle Receives: Other: Placebo taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain assessment was made with Visual Analogue Scale (VAS). The patient was asked to mark where his or her pain was on the scale by writing "0: No pain, 10: Unbearable pain" at the two ends of the 10-centimeter scale.
Measured: Baseline and 48 hours after the application
Knee extension muscle strength
A hand dynamometer (MicroFet 2 HHD) was used to measure the patients' knee extension muscle strength. Measurements were recorded in kilograms. For measurement, the patient was positioned without support, with his legs hanging off the bed from the knees, knees flexed at 90°, feet free and arms crossed over the shoulders. During the measurement, the thigh to be measured was stabilized with one hand after the patients completed maximum knee extension.
Measured: Baseline and 48 hours after the application
Secondary outcomes (5)
Fear of movement
It was evaluated with the Tampa Kinesiophobia Scale (TKÖ). This scale, developed to measure fear of movement/re-injury, consists of 17 questions. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities.
Measured: Baseline and 48 hours after the application
Proprioceptive force sense
It was evaluated with a pressurized biofeedback device. While the patients were lying on the treatment bed in a supine position, the biofeedback device was placed under the knee and its pressure was adjusted to 20 mmHg. Patients were asked to make maximum isometric contraction of the quadriceps femoris muscle and maintain it for 5 seconds. The highest value read from the device during the patients' contractions was recorded.
Measured: Baseline and 48 hours after the application
Joint range of motion
Knee flexion range of motion measurements were made using a goniometer while the patient was lying in the prone position.
Measured: Baseline and 48 hours after the application
Joint position sense
Baseline Digital Inclinometer was used for this. Knee extension movement was performed for the right and left extremities in eyes open and eyes closed positions. The reposition angle method was used to measure joint position sense. According to this method; The patient's extremity was moved to the required position by the physiotherapist. The patient was asked to remember this position by waiting 5 seconds in this position. The patient was then asked to bring his extremity back to that position.
Measured: Baseline and 48 hours after the application
Quality of life
It was evaluated using the SF-36 scale. The scale consists of a total of 36 questions in eight subsections. These sections are: physical function, body pain, limitation due to physical problems, limitation due to emotional problems, cognitive well-being, social competence, energy, general health. In the scale, each section is evaluated separately, and each question is scored between 0 and 100. The increase in score is interpreted as an improvement in health status.
Measured: Baseline and 48 hours after the application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Meniscus TearsStudies 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
- Randomised, placebo-controlled, double-blinded study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Okuyucu, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637670
- Sponsor's protocol ID
- 81180
- Status last verified
- Jul 2022
- First submitted
- 3 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.
PubMed 22124445Weiss CB, Lundberg M, Hamberg P, DeHaven KE, Gillquist J. Non-operative treatment of meniscal tears. J Bone Joint Surg Am. 1989 Jul;71(6):811-22.
PubMed 2745476Reicher MA, Hartzman S, Duckwiler GR, Bassett LW, Anderson LJ, Gold RH. Meniscal injuries: detection using MR imaging. Radiology. 1986 Jun;159(3):753-7. doi: 10.1148/radiology.159.3.3754645.
PubMed 3754645Ageberg E. Consequences of a ligament injury on neuromuscular function and relevance to rehabilitation - using the anterior cruciate ligament-injured knee as model. J Electromyogr Kinesiol. 2002 Jun;12(3):205-12. doi: 10.1016/s1050-6411(02)00022-6.
PubMed 12086815Spindler KP, Schils JP, Bergfeld JA, Andrish JT, Weiker GG, Anderson TE, Piraino DW, Richmond BJ, Medendorp SV. Prospective study of osseous, articular, and meniscal lesions in recent anterior cruciate ligament tears by magnetic resonance imaging and arthroscopy. Am J Sports Med. 1993 Jul-Aug;21(4):551-7. doi: 10.1177/036354659302100412.
PubMed 8368416
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Kinesiological Taping on Pain, Quality of Life and Musculoskeletal System Parameters in Individuals With Meniscus Injury: A Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06637670
- Acronym / sponsor ID
- 81180
- Conditions
- Meniscus Tears
- Keywords
- kinesiology taping, pain, quality of life, meniscus injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore how kinesiology taping affects people with mild to moderate meniscus injuries (grades I/II), focusing on pain, movement fears, muscle strength, balance, joint movement, and quality of life.
Two groups will be involved: one will receive kinesiology taping on the thigh muscle with some tension, while the other will receive a placebo tape with no tension. Researchers will measure various factors, including pain and muscle strength, both before and 48-72 hours after taping.
Detailed description
This study aims to understand the short-term (acute) effects of kinesiology taping on people with mild to moderate meniscus injuries (grade I/II). These injuries, affecting the cartilage in the knee, can cause pain, reduced mobility, and fear of movement. Kinesiology taping, a popular therapy, involves applying elastic tape to support muscles and joints. This research looked at whether taping could improve pain, muscle strength, movement, balance, and quality of life in patients with these knee injuries.
Study Design The study will use a randomized, placebo-controlled, and double-blinded design, meaning that patients were randomly assigned to two groups, and neither the patients nor the researchers knew which group each person was in during the treatment.
Experimental Group: will receive kinesiology taping on the quadriceps muscle (the large muscle at the front of the thigh) using a 'Y-shaped' technique with moderate tension (25-50% stretch).
Control Group: will receive a placebo tape applied without tension and placed in a different direction.
Measurements
To evaluate the effects of taping, several aspects will be measured both before the tape was applied and 48-72 hours later:
Pain levels Fear of movement (kinesiophobia) Muscle strength (ability to extend the knee) Proprioception (awareness of limb position and force applied) Joint range of motion (how much the knee can bend and straighten) Joint position sense (accuracy in detecting knee position with eyes closed) Quality of life, using a questionnaire (SF-36) that assesses various aspects like physical function and energy levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, placebo-controlled, double-blinded study
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Other: Kinesiology tapingThis group was applied 'Y shaped' kinesiology taping on quadriceps femoris muscle, based on facilitation technique with 25-50% stretching. |
| The placebo group | Placebo comparator | Other: Placebo tapingThis group was applied a tape without tension, perpendicular to the quadriceps femoris muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with meniscus grade I/II,
- Who agreed to participate in the study
- Signed the voluntary consent form
Key exclusion criteria (6 listed)
- Pregnant individuals
- Individuals with additional knee injuries (e.g., ligament tears) or chronic conditions affecting the knee (e.g., arthritis).
- Patients with grade III meniscus tears or more severe injuries.
- Who had knee surgery in the last 6 months.
- Patients with skin conditions or allergies to adhesive materials or kinesiology tape.
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 |
|---|---|---|
| Kinesiology taping'Y shaped' kinesiology taping was applied on quadriceps femoris muscle, based on facilitation technique with 25-50% stretching. | Other | The experimental group |
| Placebo tapingA tape without tension was applied perpendicular on the quadriceps femoris muscle. | Other | The placebo group |
Primary outcome
Pain
Time frame: Baseline and 48 hours after the application
Pain assessment was made with Visual Analogue Scale (VAS). The patient was asked to mark where his or her pain was on the scale by writing "0: No pain, 10: Unbearable pain" at the two ends of the 10-centimeter scale.
Knee extension muscle strength
Time frame: Baseline and 48 hours after the application
A hand dynamometer (MicroFet 2 HHD) was used to measure the patients' knee extension muscle strength. Measurements were recorded in kilograms. For measurement, the patient was positioned without support, with his legs hanging off the bed from the knees, knees flexed at 90°, feet free and arms crossed over the shoulders. During the measurement, the thigh to be measured was stabilized with one hand after the patients completed maximum knee extension.
5 secondary outcomes
Fear of movement
Time frame: Baseline and 48 hours after the application
Proprioceptive force sense
Time frame: Baseline and 48 hours after the application
Joint range of motion
Time frame: Baseline and 48 hours after the application
Joint position sense
Time frame: Baseline and 48 hours after the application
Quality of life
Time frame: Baseline and 48 hours after the application
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 15 Oct 2024.
- Results publication: PubMed 22124445Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.
- Results publication: PubMed 2745476Weiss CB, Lundberg M, Hamberg P, DeHaven KE, Gillquist J. Non-operative treatment of meniscal tears. J Bone Joint Surg Am. 1989 Jul;71(6):811-22.
- Results publication: PubMed 3754645Reicher MA, Hartzman S, Duckwiler GR, Bassett LW, Anderson LJ, Gold RH. Meniscal injuries: detection using MR imaging. Radiology. 1986 Jun;159(3):753-7. doi: 10.1148/radiology.159.3.3754645.
- Results publication: PubMed 12086815Ageberg E. Consequences of a ligament injury on neuromuscular function and relevance to rehabilitation - using the anterior cruciate ligament-injured knee as model. J Electromyogr Kinesiol. 2002 Jun;12(3):205-12. doi: 10.1016/s1050-6411(02)00022-6.
- Results publication: PubMed 8368416Spindler KP, Schils JP, Bergfeld JA, Andrish JT, Weiker GG, Anderson TE, Piraino DW, Richmond BJ, Medendorp SV. Prospective study of osseous, articular, and meniscal lesions in recent anterior cruciate ligament tears by magnetic resonance imaging and arthroscopy. Am J Sports Med. 1993 Jul-Aug;21(4):551-7. doi: 10.1177/036354659302100412.
- 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 Kinesiology taping in people with Meniscus Tears, run by Amasya 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 3 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Baseline and 48 hours after the application). 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?
On the ClinicalTrials.gov record for NCT06637670, which also lists 5 linked publications.
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 15 Oct 2024.