Patellofemoral Pain SyndromeNCT02241148
Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome
A study testing Acetaminophen 500mg and Kinesio taping in people with Patellofemoral Pain Syndrome, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Acetaminophen 500mg and Kinesio taping
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2014to 17 Aug 2017
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between fifteen and thirty-five years,
- Presenting unilateral PFPS with six months of evolution,
- Presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities:
- (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at least thirty minutes of physical activity at least three times per week.)
Who cannot join
- Patients with previous knee surgeries,
- Chronic pain with more than one year of evolution,
- Pregnancy or suspected pregnancy
- Application of intra-articular steroids in the three months prior to their evaluation
- Patients with meniscal injuries
- Ligament or intra-articular knee structures
Show all 12Show fewer
- Degenerative diseases such as diabetes
- Rheumatoid arthritis
- Osteoarthritis of the knee, hip or ankle
- History of dislocation or subluxation of patella
- Osgood Schlatter syndrome
- Patellar tendinitis or quadriceps.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome.
The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome.
Two groups would be made, the control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both groups will be evaluated by an external consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the beginning, third and sixth week
Read the detailed description
The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting unilateral Patellofemoral pain syndrome with six months of evolution, presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities: squatting, running, kneeling, jumping, or climbing stairs; physically active patients, with at least thirty minutes of physical activity at least three times per week. Exclusion criteria include patients with previous knee surgeries, chronic pain with more than one year of evolution, pregnancy or suspected pregnancy, application of intra-articular steroids in the three months prior to their evaluation, patients with meniscal injuries, ligament or intra-articular knee structures, degenerative diseases such as diabetes, rheumatoid arthritis, Osteoarthritis of the knee, hip or ankle, history of dislocation or subluxation of patella, Osgood Schlatter syndrome and patellar tendinitis or quadriceps.
The investigators will divide patients into two groups. The control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both groups will be evaluated by an external consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the beginning, third and sixth week. The patients in the experimental group will be quoted each week to change the tape. The control group will be quoted at the beginning, at three weeks and after six weeks. During the first appointment we will take patients anthropometric measurements (weight, height, BMI) as well as general information. Radiographic studies (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out other diseases and see the degree of contact of the patella on the patellofemoral joint. All patients will receive an explanation about their illness, and a booklet with the required exercises as well as their frequency.
For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips that were placed inferior to the head with no pressure applied, then two bands are placed at the ends of the tape and crossed on the edges of the patella and ending at the thigh to finish applying moderate tension to place them, then two strips were placed at each end of the edges of the first and second tape without applying pressure. The tapes can last up to five days on the extremities while maintaining their purpose, patients included in this group will be summoned each week to remove the tapes and place new ones.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Acetaminophen 500mg, Kinesio taping
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 500mgDrug
Also called Tempra® 500mg
500 mg, tablets every 8 hours
Kinesio tapingDevice
Also called SpiderTech ® Kinesio taping
Taping will be changed every week.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen 500mg | Active comparator | The control group will receive treatment with acetaminophen 500mg and physical therapy rehabilitation Receives: Drug: Acetaminophen 500mg |
| Kinesio taping | Experimental | The experimental treatment group will receive acetaminophen 500mg and physical therapy rehabilitation, plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping Receives: Device: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closed kinetic chain exercise with kinesio taping pain relief measured in the Kujala score
The Kujala patellofemoral score is a functional evaluation instrument to evaluate knee problems related to the patellofemoral system.It is a 13-item knee-specific self-report questionnaire.
It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion.
Measured: Baseline,3 weeks, 6 weeks
Secondary outcomes (1)
Closed kinetic chain exercise with kinesio taping pain relief measured in the Tegner Activity Scale.
The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is 'participation in competitive sports such as soccer at a national or international elite level
Measured: Baseline, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completion17 Aug 2017
- Study completion17 Aug 2017
Why it stopped: Required number of participants were not able to be enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon
- Investigators
- Felix Vilchez, Dr. med., Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241148
- Sponsor's protocol ID
- OR14-003
- Other IDs
- OR14-003, OR14-003, OR14-003
- Status last verified
- Oct 2019
- First submitted
- 26 Jul 2014
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT02241148
- Acronym / sponsor ID
- OR14-003
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Required number of participants were not able to be enrolled.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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 investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome.
Two groups would be made, the control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both groups will be evaluated by an external consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the beginning, third and sixth week
Detailed description
The investigators will include patients attending outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of unilateral Patellofemoral Pain Syndrome. Inclusion criteria are: age between fifteen and thirty-five years, presenting unilateral Patellofemoral pain syndrome with six months of evolution, presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities: squatting, running, kneeling, jumping, or climbing stairs; physically active patients, with at least thirty minutes of physical activity at least three times per week. Exclusion criteria include patients with previous knee surgeries, chronic pain with more than one year of evolution, pregnancy or suspected pregnancy, application of intra-articular steroids in the three months prior to their evaluation, patients with meniscal injuries, ligament or intra-articular knee structures, degenerative diseases such as diabetes, rheumatoid arthritis, Osteoarthritis of the knee, hip or ankle, history of dislocation or subluxation of patella, Osgood Schlatter syndrome and patellar tendinitis or quadriceps.
The investigators will divide patients into two groups. The control group will receive treatment with acetaminophen and physical therapy rehabilitation, closed chain exercises and stretches at home intended for the strengthening of quadriceps, abductors and internal rotators of the hip for the duration of six weeks. The experimental treatment group will receive the above plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping on the affected knee. Both groups will be evaluated by an external consultation. They will be assessed by the Tegner Activity Scale, the Kujala score of the WOMAC and visual analog scale (VAS) for pain assessment; these scales will be applied at the beginning, third and sixth week. The patients in the experimental group will be quoted each week to change the tape. The control group will be quoted at the beginning, at three weeks and after six weeks. During the first appointment we will take patients anthropometric measurements (weight, height, BMI) as well as general information. Radiographic studies (anteroposterior and lateral knee, plus the projection Merchant) will be sought to rule out other diseases and see the degree of contact of the patella on the patellofemoral joint. All patients will receive an explanation about their illness, and a booklet with the required exercises as well as their frequency.
For patients to be included in the group of Spider ® Taping, Kinesio Tape pre-cut strips that were placed inferior to the head with no pressure applied, then two bands are placed at the ends of the tape and crossed on the edges of the patella and ending at the thigh to finish applying moderate tension to place them, then two strips were placed at each end of the edges of the first and second tape without applying pressure. The tapes can last up to five days on the extremities while maintaining their purpose, patients included in this group will be summoned each week to remove the tapes and place new ones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen 500mg | Active comparator | Drug: Acetaminophen 500mgThe control group will receive treatment with acetaminophen 500mg and physical therapy rehabilitation |
| Kinesio taping | Experimental | Device: Kinesio tapingThe experimental treatment group will receive acetaminophen 500mg and physical therapy rehabilitation, plus the application of the technique NUCAP Medical Upper Knee Spider ® Kinesio taping |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between fifteen and thirty-five years,
- Presenting unilateral PFPS with six months of evolution,
- Presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities:
- (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at least thirty minutes of physical activity at least three times per week.)
Key exclusion criteria (12 listed)
- Patients with previous knee surgeries,
- Chronic pain with more than one year of evolution,
- Pregnancy or suspected pregnancy
- Application of intra-articular steroids in the three months prior to their evaluation
- Patients with meniscal injuries
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 |
|---|---|---|
| Acetaminophen 500mgAlso: Tempra® 500mg500 mg, tablets every 8 hours | Drug | Acetaminophen 500mg |
| Kinesio tapingAlso: SpiderTech ® Kinesio tapingTaping will be changed every week. | Device | Kinesio taping |
Primary outcome
Closed kinetic chain exercise with kinesio taping pain relief measured in the Kujala score
Time frame: Baseline,3 weeks, 6 weeks
The Kujala patellofemoral score is a functional evaluation instrument to evaluate knee problems related to the patellofemoral system.It is a 13-item knee-specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion.
1 secondary outcome
Closed kinetic chain exercise with kinesio taping pain relief measured in the Tegner Activity Scale.
Time frame: Baseline, 3 weeks, 6 weeks
Results and safety
The study was stopped early (reason given: Required number of participants were not able to be enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
Felix Vilchez, Dr. med. principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen 500mg and Kinesio taping in people with Patellofemoral Pain Syndrome, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 23 Oct 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 Mexico. 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 was stopped early (reason given: Required number of participants were not able to be enrolled.). 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?
Closed kinetic chain exercise with kinesio taping pain relief measured in the Kujala score (time frame: Baseline,3 weeks, 6 weeks). 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 23 Oct 2019.