NCT02241148

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

3.5 years

First QC Date

July 26, 2014

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (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.

    Baseline,3 weeks, 6 weeks

Secondary Outcomes (1)

  • Closed kinetic chain exercise with kinesio taping pain relief measured in the Tegner Activity Scale.

    Baseline, 3 weeks, 6 weeks

Other Outcomes (2)

  • Closed kinetic chain exercise with kinesio taping pain relief measured in WOMAC

    Baseline, 3 weeks, 6 weeks

  • Closed kinetic chain exercise with kinesio taping pain relief measured in the visual analog scale (VAS) for pain assessment.

    Baseline, 3 weeks, 6 weeks

Study Arms (2)

Acetaminophen 500mg

ACTIVE COMPARATOR

The control group will receive treatment with acetaminophen 500mg and physical therapy rehabilitation

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

Device: Kinesio taping

Interventions

500 mg, tablets every 8 hours

Also known as: Tempra® 500mg
Acetaminophen 500mg

Taping will be changed every week.

Also known as: SpiderTech ® Kinesio taping
Kinesio taping

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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
  • Patellar tendinitis or quadriceps.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina UANL

Monterrey, Nuevo León, 66235, Mexico

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Felix Vilchez, Dr. med.

    Universidad Autonoma de Nuevo Leon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Felix Vilchez Cavazos

Study Record Dates

First Submitted

July 26, 2014

First Posted

September 16, 2014

Study Start

February 1, 2014

Primary Completion

August 17, 2017

Study Completion

August 17, 2017

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations