Patellofemoral Pain SyndromeNCT04975113
The Effects of Progressive Neuromuscular Exercise Program and Taping on Muscle Strength and Pain in Patellofemoral Pain
A study testing progressive neuromuscular exercise program and Exercise and Taping in people with Patellofemoral Pain Syndrome and Kinesiotape, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Neuromuscular exercise and taping are widely used in the rehabilitation of Patellofemoral Pain. The aim of this study was to investigate the effects of corrective kinesio taping applied on patellofemoral joint and foot in addition to a progressive neuromuscular exercise program in women with Patellofemoral Pain on… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome, Kinesiotape, Exercise
- What is being tested?
- progressive neuromuscular exercise program and Exercise and Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2015to 20 Dec 2015
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- In order for them to be included in the study, it was necessary to have patellofemoral pain in at least two of the long-term sitting, climbing and descending stairs / climbing activities, squatting, running and jumping, and these pains had to continue for at least six months.
Who cannot join
- Patients with other knee pathologies and knee joint surgery were excluded in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Ankara, 06760
About this study
Official title: The Effects of Progressive Neuromuscular Exercise Program and Taping on Muscle Strength and Pain in Patellofemoral Pain: A Randomized Controlled Blind Study
Neuromuscular exercise and taping are widely used in the rehabilitation of Patellofemoral Pain. The aim of this study was to investigate the effects of corrective kinesio taping applied on patellofemoral joint and foot in addition to a progressive neuromuscular exercise program in women with Patellofemoral Pain on knee pain and muscle strength.
Read the detailed description
Patellofemoral Pain (PFP) is characterized by pain localized in the peripatellar or retropatellar regions in young and physically active individuals . In patients with PFP, during single-leg squatting, an increase in the valgus of the knee joint due to hip abductor muscle weakness and in the internal rotation of the femur due to weakness of the hip external rotators and abductor muscles are observed. Theoretically it has been shown that faulty hip kinematics can increase lateral loading in the patellofemoral joint. Therefore, conducting exercises to strengthen the extensor, external rotator, and abductor muscles of the hip and lateral flexor muscles of the trunk are an important treatment approaches. Strengthening the quadriceps muscle is a widely used method of treating PFP. Previous studies suggest that hip and trunk exercises prescribed in combination with traditional quadriceps strengthening exercises are effective in reducing pain and improving function in patients with PFP .
In recent years, kinesiotape is one of the widely used methods in the treatment of PFP. The correction of the abnormal patellar displacement, the reduction of the patellofemoral joint reaction forces, and the regulation of the activation of the vastus medialis muscle is provided with patellar taping. Patellar taping is recommended as part of evidence-based combined physiotherapy programs in the treatment of PFP . Increased pronation of the subtalar joint and the decrease / flattening of the medial arch height are associated with PFP. Prolonged pronation time is observed in subtalar and midtarsal joints during gait. To correct increased pronation, foot orthoses, low-dye taping and kinesio taping are applied . The effect of kinesiotaping on foot pronation, however, is unclear due to the lack of published studies.
To our knowledge, although patellar taping is applied in patients with PFP no studies have examined the effects of kinesiotaping supporting the medial arch and allowing forefoot and hind foot to move within the normal range. The aim of this study was to investigate the effects of corrective kinesio taping applied on patellofemoral joint and foot in addition to a progressive neuromuscular exercise program in women with Patellofemoral Pain on knee pain and muscle strength.
- Conditions
- Patellofemoral Pain Syndrome, Kinesiotape, Exercise, Strength
- Being tested
- progressive neuromuscular exercise program, Exercise and Taping
- Keywords
- strength, neuromuscular exercise, Kinesiotape, Patellofemoral Pain Syndrome
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive neuromuscular exercise programOther
The exercises to be performed in the following week at the beginning of each week were explained by the researcher physiotherapist on the brochure and given as a home program and continued for a total of 12 weeks. The researcher physiotherapist saw the patients every week and carried out exercise compliance and control.
Exercise and TapingOther
"I" taping for accurate positioning of the tissue was applied to the patients to neutralize the patellofemoral joint. During the knee flexion in the supine position, the tape was adhered to the skin with a moderate-to-extreme stretch (50%-75%) . Clinical therapeutic applications of the Kinesio taping methods (Tokyo, Japan: Ken Ikai Co Ltd.). In addition to the patellar taping, correction taping to neutralize the subtalar joint by elevating the midtarsal joint and medial arch was applied. The patients were positioned in prone lying and knee flexion position, the taping was started at the 5th metatarsal level on the dorsal side of the finger and finished extending towards the medial of the tibia . Tapings were renewed at the beginning of each week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Patients were given a progressive neuromuscular exercise program that included stabilization of the knee and hip joint . Green color elastic band was used in resistant exercises. When subjects used the green color Thera-Band®, they started with an easy length and increased relative to the Omni Scale . Receives: Other: progressive neuromuscular exercise program |
| Exercise and Taping group | Experimental | Patients in this group received the same exercises given in the "exercise group" for 12 weeks. In addition to these exercises, mechanical correction tape (5cm, Kinesio Tex Gold®) was applied for the knee and foot. Receives: Other: Exercise and Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Visual Analogue Pain Scale score at 6th. weeks and 12th. weeks
The knee pain of the patients during stair descending and ascending were evaluated with the Visual Analogue Pain Scale (VAS). The scale is horizontal in the form of a line 10 cm long, starting with "no pain" and ending with "excruciating pain". The pain was measured and recorded as "cm" between the point marked with no onset .
Measured: before and after treatment (12 sessions, 6th. and 12th. weeks)]
Change from isokinetic muscle strength of the hamstring and quadriceps femoris muscles at 6th. weeks and 12th. weeks
Isokinetic dynamometer (Isomed 2000. D\&R. Ferstl GmbH, Germany) was used to evaluate the isokinetic muscle strength of the hamstring and quadriceps femoris muscles. Patients were fixed to the chair with trunk, pelvis, and thigh straps with the back of the seat 70° upright. Concentric peak torque / weight (Nm / kg) at 180° / sec (10 repetitions) after 4 repetitive warm-ups at 180° / sec, in the range of 45 °-90° flexion values were measured, respectively .
Measured: before and after treatment (12 sessions, 6th. and 12th. weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Aug 2015
- Primary completion20 Dec 2015
- Study completion20 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pınar Balcı, Principal investigator, Muğla Sıtkı Koçman UniversityRabia Tugba Kilic, Study director, Ankara Yildirim Beyazıt UniversityVolga Bayrakci Tunay, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975113
- Sponsor's protocol ID
- GO 13/314-01
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater Reliability of Functional Performance Tests for Subjects With Patellofemoral Pain Syndrome. J Athl Train. 2002 Sep;37(3):256-261.
PubMed 12937582Colado JC, Garcia-Masso X, Triplett NT, Calatayud J, Flandez J, Behm D, Rogers ME. Construct and concurrent validation of a new resistance intensity scale for exercise with thera-band(R) elastic bands. J Sports Sci Med. 2014 Dec 1;13(4):758-66. eCollection 2014 Dec.
PubMed 25435767Aguilar MB, Abian-Vicen J, Halstead J, Gijon-Nogueron G. Effectiveness of neuromuscular taping on pronated foot posture and walking plantar pressures in amateur runners. J Sci Med Sport. 2016 Apr;19(4):348-53. doi: 10.1016/j.jsams.2015.04.004. Epub 2015 Apr 24.
PubMed 25956688Baldon Rde M, Serrao FV, Scattone Silva R, Piva SR. Effects of functional stabilization training on pain, function, and lower extremity biomechanics in women with patellofemoral pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):240-251, A1-A8. doi: 10.2519/jospt.2014.4940. Epub 2014 Feb 25.
PubMed 24568258
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Progressive Neuromuscular Exercise Program and Taping on Muscle Strength and Pain in Patellofemoral Pain: A Randomized Controlled Blind Study
- ClinicalTrials.gov ID
- NCT04975113
- Acronym / sponsor ID
- GO 13/314-01
- Conditions
- Patellofemoral Pain Syndrome, Kinesiotape, Exercise, Strength
- Keywords
- strength, neuromuscular exercise, Kinesiotape, Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 20 Dec 2015 (actual)
- Study completion
- 20 Dec 2015 (actual)
- First posted
- 23 Jul 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.
Neuromuscular exercise and taping are widely used in the rehabilitation of Patellofemoral Pain. The aim of this study was to investigate the effects of corrective kinesio taping applied on patellofemoral joint and foot in addition to a progressive neuromuscular exercise program in women with Patellofemoral Pain on knee pain and muscle strength.
Detailed description
Patellofemoral Pain (PFP) is characterized by pain localized in the peripatellar or retropatellar regions in young and physically active individuals . In patients with PFP, during single-leg squatting, an increase in the valgus of the knee joint due to hip abductor muscle weakness and in the internal rotation of the femur due to weakness of the hip external rotators and abductor muscles are observed. Theoretically it has been shown that faulty hip kinematics can increase lateral loading in the patellofemoral joint. Therefore, conducting exercises to strengthen the extensor, external rotator, and abductor muscles of the hip and lateral flexor muscles of the trunk are an important treatment approaches. Strengthening the quadriceps muscle is a widely used method of treating PFP. Previous studies suggest that hip and trunk exercises prescribed in combination with traditional quadriceps strengthening exercises are effective in reducing pain and improving function in patients with PFP .
In recent years, kinesiotape is one of the widely used methods in the treatment of PFP. The correction of the abnormal patellar displacement, the reduction of the patellofemoral joint reaction forces, and the regulation of the activation of the vastus medialis muscle is provided with patellar taping. Patellar taping is recommended as part of evidence-based combined physiotherapy programs in the treatment of PFP . Increased pronation of the subtalar joint and the decrease / flattening of the medial arch height are associated with PFP. Prolonged pronation time is observed in subtalar and midtarsal joints during gait. To correct increased pronation, foot orthoses, low-dye taping and kinesio taping are applied . The effect of kinesiotaping on foot pronation, however, is unclear due to the lack of published studies.
To our knowledge, although patellar taping is applied in patients with PFP no studies have examined the effects of kinesiotaping supporting the medial arch and allowing forefoot and hind foot to move within the normal range. The aim of this study was to investigate the effects of corrective kinesio taping applied on patellofemoral joint and foot in addition to a progressive neuromuscular exercise program in women with Patellofemoral Pain on knee pain and muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: progressive neuromuscular exercise programPatients were given a progressive neuromuscular exercise program that included stabilization of the knee and hip joint . Green color elastic band was used in resistant exercises. When subjects used the green color Thera-Band®, they started with an easy length and increased relative to the Omni Scale . |
| Exercise and Taping group | Experimental | Other: Exercise and TapingPatients in this group received the same exercises given in the "exercise group" for 12 weeks. In addition to these exercises, mechanical correction tape (5cm, Kinesio Tex Gold®) was applied for the knee and foot. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In order for them to be included in the study, it was necessary to have patellofemoral pain in at least two of the long-term sitting, climbing and descending stairs / climbing activities, squatting, running and jumping, and these pains had to continue for at least six months.
Key exclusion criteria (1 listed)
- Patients with other knee pathologies and knee joint surgery were excluded in the study.
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 |
|---|---|---|
| progressive neuromuscular exercise programThe exercises to be performed in the following week at the beginning of each week were explained by the researcher physiotherapist on the brochure and given as a home program and continued for a total of 12 weeks. The researcher physiotherapist saw the patients every week and carried out exercise compliance and control. | Other | Exercise group |
| Exercise and Taping"I" taping for accurate positioning of the tissue was applied to the patients to neutralize the patellofemoral joint. During the knee flexion in the supine position, the tape was adhered to the skin with a moderate-to-extreme stretch (50%-75%) . Clinical therapeutic applications of the Kinesio taping methods (Tokyo, Japan: Ken Ikai Co Ltd.). In addition to the patellar taping, correction taping to neutralize the subtalar joint by elevating the midtarsal joint and medial arch was applied. The patients were positioned in prone lying and knee flexion position, the taping was started at the 5th metatarsal level on the dorsal side of the finger and finished extending towards the medial of the tibia . Tapings were renewed at the beginning of each week for 6 weeks. | Other | Exercise and Taping group |
Primary outcome
Change from Visual Analogue Pain Scale score at 6th. weeks and 12th. weeks
Time frame: before and after treatment (12 sessions, 6th. and 12th. weeks)]
The knee pain of the patients during stair descending and ascending were evaluated with the Visual Analogue Pain Scale (VAS). The scale is horizontal in the form of a line 10 cm long, starting with "no pain" and ending with "excruciating pain". The pain was measured and recorded as "cm" between the point marked with no onset .
Change from isokinetic muscle strength of the hamstring and quadriceps femoris muscles at 6th. weeks and 12th. weeks
Time frame: before and after treatment (12 sessions, 6th. and 12th. weeks)]
Isokinetic dynamometer (Isomed 2000. D\&R. Ferstl GmbH, Germany) was used to evaluate the isokinetic muscle strength of the hamstring and quadriceps femoris muscles. Patients were fixed to the chair with trunk, pelvis, and thigh straps with the back of the seat 70° upright. Concentric peak torque / weight (Nm / kg) at 180° / sec (10 repetitions) after 4 repetitive warm-ups at 180° / sec, in the range of 45 °-90° flexion values were measured, respectively .
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 23 Jul 2021.
- Background: PubMed 12937582Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater Reliability of Functional Performance Tests for Subjects With Patellofemoral Pain Syndrome. J Athl Train. 2002 Sep;37(3):256-261.
- Background: PubMed 25435767Colado JC, Garcia-Masso X, Triplett NT, Calatayud J, Flandez J, Behm D, Rogers ME. Construct and concurrent validation of a new resistance intensity scale for exercise with thera-band(R) elastic bands. J Sports Sci Med. 2014 Dec 1;13(4):758-66. eCollection 2014 Dec.
- Background: PubMed 25956688Aguilar MB, Abian-Vicen J, Halstead J, Gijon-Nogueron G. Effectiveness of neuromuscular taping on pronated foot posture and walking plantar pressures in amateur runners. J Sci Med Sport. 2016 Apr;19(4):348-53. doi: 10.1016/j.jsams.2015.04.004. Epub 2015 Apr 24.
- Background: PubMed 24568258Baldon Rde M, Serrao FV, Scattone Silva R, Piva SR. Effects of functional stabilization training on pain, function, and lower extremity biomechanics in women with patellofemoral pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):240-251, A1-A8. doi: 10.2519/jospt.2014.4940. Epub 2014 Feb 25.
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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.
Pınar Balcı principal investigator
Muğla Sıtkı Koçman University
Rabia Tugba Kilic study director
Ankara Yildirim Beyazıt University
Volga Bayrakci Tunay study chair
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 progressive neuromuscular exercise program and Exercise and Taping in people with Patellofemoral Pain Syndrome and Kinesiotape, run by Ankara Yildirim Beyazıt 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: finished, as of the sponsor's last update on 23 Jul 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?
Change from Visual Analogue Pain Scale score at 6th. weeks and 12th. weeks (time frame: before and after treatment (12 sessions, 6th. and 12th. 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?
On the ClinicalTrials.gov record for NCT04975113, which also lists 4 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 23 Jul 2021.