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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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.

Mexico1 site
  • Facultad de Medicina UANL

    Monterrey, Nuevo León, 66235

Other trials in Mexico

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.

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 groups in NCT02241148
Study groupRoleWhat they receive
Acetaminophen 500mgActive comparatorThe control group will receive treatment with acetaminophen 500mg and physical therapy rehabilitation
Receives: Drug: Acetaminophen 500mg
Kinesio tapingExperimentalThe 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.

  1. 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)
  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.

  1. First posted16 Sep 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completion17 Aug 2017
  4. Study completion17 Aug 2017

Why it stopped: Required number of participants were not able to be enrolled.

Resources

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)
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

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.

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