Medial Plica SyndromeNCT04085497
Kinesio Tape in the Treatment of Medial Plica Syndrome
A study testing Treatment in people with Medial Plica Syndrome, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the efficacy of kinesio tape (KT) on pain severity, pain threshold, lower extremity functional muscle strength and dynamic balance, functional status, and quality of life in patients with Medial Plica Syndrome (MPS). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Medial Plica Syndrome
- What is being tested?
- Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 1 Oct 2019
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 20 and 55
- Diagnosed as medial plica syndrome by MPP test and MRI imaging
- Did not develop cartilage damage
Who cannot join
- Patients with meniscal tear, chondral injury or instability of the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Kinesio Tape in the Treatment of Medial Plica Syndrome - A Prospective Study
The aim of this study was to investigate the efficacy of kinesio tape (KT) on pain severity, pain threshold, lower extremity functional muscle strength and dynamic balance, functional status, and quality of life in patients with Medial Plica Syndrome (MPS).
Read the detailed description
This randomized prospective controlled trial was designed, conducted and reported in accordance with the standards of the CONSORT (Consolidated Standards of Reporting Trials) statement. The approval of the Istanbul Bilgi University Clinical Investigations Ethics Committee was obtained, and the enrolled subjects signed a free and informed consent form.
Trial design KT was applied once a week, 6 times in total. Exercises were performed for all patients for 5 weeks 5 days a week, 3 sets 15 repetitions each day. The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups.
Intervention KT application: KT application includes 2 stages. The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee. The second step is directed directly on the medial plica to benefit from its analgesic effect. For the first step, an I-band is measured from the top of the patella to the tuberositas tibia. I-band is 6 cm wide and 5 mm thick. This I-band is cut into Y-band. First, the part of the band above the patella is pasted with 10% tension. Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension. The tails of the band are combined together on the tuberositas and completed. For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared. The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
Participants The study was included 80 patients with diagnosed as MPS in the Orthopedics and Traumatology outpatient clinic of Bağcılar Training and Research Hospital. MPS was diagnosed by MRI imaging in patients with pain and MPP test in the patella anteromedial. The patients were divided into two groups, each comprising 50 patients. KT and exercise were given to the patients in the first group, and only exercise was given to the patients in the second group. The inclusion criteria included patients between the ages of 20 and 55 who were diagnosed as MPS by MPP test and MRI imaging and did not develop cartilage damage. Patients with meniscal tear, chondral injury or instability of the knee were excluded.
Outcome measurements Measurements were performed twice before and after the treatment for all patients. Pain threshold with digital algometer, pain severity with visual analog scale (VAS), disability level with Lysholm Knee Scoring Scale, functional strength and dynamic balance of lower extremity with stairs up and down test, quality of life with Nottingham Health Profile (NHP) were evaluated before and after treatment.
- Conditions
- Medial Plica Syndrome
- Being tested
- Treatment
- Keywords
- Medial Plica Syndrome, Kinesio Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
KT application: KT application includes 2 stages. The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee. The second step is directed directly on the medial plica to benefit from its analgesic effect. For the first step, an I-band is measured from the top of the patella to the tuberositas tibia. I-band is 6 cm wide and 5 mm thick. This I-band is cut into Y-band. First, the part of the band above the patella is pasted with 10% tension. Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension. The tails of the band are combined together on the tuberositas and completed. For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared. The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | KT was applied once a week, 6 times in total. Exercises were performed for all patients for 5 weeks 5 days a week, 3 sets 15 repetitions each day. Receives: Other: Treatment |
| Group 2 | Placebo comparator | The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups. Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain threshold
Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests
Measured: 1 minute
Secondary outcomes (3)
Pain severity: score
Participants were told how to do it and were asked to give a score between 0-100
Measured: 1 minutes
Disability scale
The Lysholm Knee Scoring scale is a scale used in all knee injuries. 8 parameters (limp, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, squatting) are evaluated.When calculating the score, the most appropriate option is selected in each parameter and the total score is found by adding the scores obtained from the whole parameter. Lysholm knee score; ≥95 points are rated as 'excellent', 84-94 points as 'good', 65-83 points as 'moderate', ≤64 points as 'bad'.
Measured: 5 minutes
Nottingham Health Profile
The Nottingham Health Profile (NHP) was used to determine quality of life of the participants. This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life. These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item). Each section is scored from 0-100. 0 indicates the best health status, 100 indicates the worst health status.
Measured: 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start2 Jan 2019
- Primary completion10 May 2019
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Plica SyndromeStudies 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
- The patients were divided into two groups, each comprising 40 patients. KT and exercise were given to the patients in the first group, and only exercise was given to the patients in the second group. The inclusion criteria included patients between the ages of 20 and 55 who were diagnosed as MPS by MPP test and MRI imaging and did not develop cartilage damage. Patients with meniscal tear, chondral injury or instability of the knee were excluded.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- Tomri̇s Duymaz, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085497
- Sponsor's protocol ID
- MPS
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kinesio Tape in the Treatment of Medial Plica Syndrome - A Prospective Study
- ClinicalTrials.gov ID
- NCT04085497
- Acronym / sponsor ID
- MPS
- Conditions
- Medial Plica Syndrome
- Keywords
- Medial Plica Syndrome, Kinesio Tape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 11 Sep 2019 (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 aim of this study was to investigate the efficacy of kinesio tape (KT) on pain severity, pain threshold, lower extremity functional muscle strength and dynamic balance, functional status, and quality of life in patients with Medial Plica Syndrome (MPS).
Detailed description
This randomized prospective controlled trial was designed, conducted and reported in accordance with the standards of the CONSORT (Consolidated Standards of Reporting Trials) statement. The approval of the Istanbul Bilgi University Clinical Investigations Ethics Committee was obtained, and the enrolled subjects signed a free and informed consent form.
Trial design KT was applied once a week, 6 times in total. Exercises were performed for all patients for 5 weeks 5 days a week, 3 sets 15 repetitions each day. The exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups.
Intervention KT application: KT application includes 2 stages. The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee. The second step is directed directly on the medial plica to benefit from its analgesic effect. For the first step, an I-band is measured from the top of the patella to the tuberositas tibia. I-band is 6 cm wide and 5 mm thick. This I-band is cut into Y-band. First, the part of the band above the patella is pasted with 10% tension. Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension. The tails of the band are combined together on the tuberositas and completed. For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared. The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
Participants The study was included 80 patients with diagnosed as MPS in the Orthopedics and Traumatology outpatient clinic of Bağcılar Training and Research Hospital. MPS was diagnosed by MRI imaging in patients with pain and MPP test in the patella anteromedial. The patients were divided into two groups, each comprising 50 patients. KT and exercise were given to the patients in the first group, and only exercise was given to the patients in the second group. The inclusion criteria included patients between the ages of 20 and 55 who were diagnosed as MPS by MPP test and MRI imaging and did not develop cartilage damage. Patients with meniscal tear, chondral injury or instability of the knee were excluded.
Outcome measurements Measurements were performed twice before and after the treatment for all patients. Pain threshold with digital algometer, pain severity with visual analog scale (VAS), disability level with Lysholm Knee Scoring Scale, functional strength and dynamic balance of lower extremity with stairs up and down test, quality of life with Nottingham Health Profile (NHP) were evaluated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The patients were divided into two groups, each comprising 40 patients. KT and exercise were given to the patients in the first group, and only exercise was given to the patients in the second group. The inclusion criteria included patients between the ages of 20 and 55 who were diagnosed as MPS by MPP test and MRI imaging and did not develop cartilage damage. Patients with meniscal tear, chondral injury or instability of the knee were excluded.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: TreatmentKT was applied once a week, 6 times in total. Exercises were performed for all patients for 5 weeks 5 days a week, 3 sets 15 repetitions each day. |
| Group 2 | Placebo comparator | Other: TreatmentThe exercise program included quadriceps set exercise, straight leg lifting, mini squat, stretching to hamstring and gastrosoleus muscle groups. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the ages of 20 and 55
- Diagnosed as medial plica syndrome by MPP test and MRI imaging
- Did not develop cartilage damage
Key exclusion criteria (1 listed)
- Patients with meniscal tear, chondral injury or instability of the knee
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 |
|---|---|---|
| TreatmentKT application: KT application includes 2 stages. The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee. The second step is directed directly on the medial plica to benefit from its analgesic effect. For the first step, an I-band is measured from the top of the patella to the tuberositas tibia. I-band is 6 cm wide and 5 mm thick. This I-band is cut into Y-band. First, the part of the band above the patella is pasted with 10% tension. Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension. The tails of the band are combined together on the tuberositas and completed. For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared. The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape. | Other | Group 2, Treatment |
Primary outcome
Pain threshold
Time frame: 1 minute
Algometer is a tool that measures pressure pain threshold and pain tolerance in quantitative sensory tests
3 secondary outcomes
Pain severity: score
Time frame: 1 minutes
Disability scale
Time frame: 5 minutes
Nottingham Health Profile
Time frame: 8 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: No
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.
Tomri̇s Duymaz principal investigator
Istanbul Bilgi 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 Treatment in people with Medial Plica Syndrome, run by Istanbul Bilgi 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 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 13 Sep 2019. 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?
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?
Pain threshold (time frame: 1 minute). 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 13 Sep 2019.