NCT01434966

Brief Summary

The purpose of this study is to determine if interventions applied at a distant site, lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied locally at the knee (TENS) on quadriceps force output and activation as well as reports of pain during common exercises in individuals with PFPS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

September 14, 2011

Last Update Submit

December 10, 2015

Conditions

Patellofemoral Pain SyndromeChondromalacia PatellaeAnterior Knee Pain Syndrome

Keywords

Lumbopelvic ManipulationLumbosacral ManipulationSacroiliac ManipulationTENS SpineTENS KneeKnee PainChronic Knee Pain

Outcome Measures

Primary Outcomes (1)

  • Quadriceps force output and activation

    Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.

    Single Study Visit

Secondary Outcomes (1)

  • Knee pain during exercise

    Single Study Visit

Study Arms (3)

Lumbopelvic Manipulation

EXPERIMENTAL

The lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual.

Other: Lumbopelvic Manipulation

TENS- Spine

EXPERIMENTAL

The TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.

Other: TENS- Spine

TENS- Knee

EXPERIMENTAL

The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.

Other: TENS- Knee

Interventions

Lumbopelvic ManipulationOTHER

The lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual.

Also known as: Grade V mobilization, High velocity, low amplitude thrust mobilization
Lumbopelvic Manipulation
TENS- SpineOTHER

The TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.

Also known as: Transcutaneous electrical nerve stimulation (TENS), Electrical stimulation
TENS- Spine
TENS- KneeOTHER

The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.

Also known as: Transcutaneous electrical nerve stimulation (TENS), Electrical stimulation
TENS- Knee

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15-50 years
  • Insidious onset of patellofemoral pain lasting greater than 1 month in duration
  • Unilateral or Bilateral knee pain or dysfunction with at least two of the following symptoms: patella compression, squatting, prolonged sitting, going up or down stairs, or isometric quadriceps contraction.

You may not qualify if:

  • Participants who are outside of age range (to ensure bony maturity while reducing the prevalence of age related degenerative changes and hypomobility.)
  • Ligamentous insufficiency, meniscus damage, patellar tendonitis, history of subluxation/dislocation
  • Participants with traumatic spine or lower extremity injury within past 6 months
  • Participants who have had previous adverse reactions to electrical stimulation (i.e. electrode burns.)
  • Participants with signs indicating lumbar nerve root compression or upper motor neuron lesions (contraindication for lumbopelvic joint manipulation)
  • Participants with ankylosing spondylitis (contraindication for lumbopelvic manipulation)
  • Participants with spinal cord disease or cauda equina (contraindication for lumbopelvic manipulation)
  • Participants with osteoporosis (contraindication for lumbopelvic joint manipulation)
  • Participants with rheumatoid arthritis (contraindication to lumbopelvic joint manipulation.)
  • Participants who may be currently pregnant. (contraindication for electrical stimulation and lumbopelvic joint manipulation.)
  • Participants who have a demand-type cardiac pacemaker (contraindication for electrical stimulation)
  • Participants with diagnosis of cancer (current cancer is a contraindication for electrical stimulation and relative contraindication for lumbopelvic joint manipulation)
  • Participants who are unable to give consent or are unable to understand procedures of experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromeChondromalacia Patellae

Interventions

Transcutaneous Electric Nerve StimulationElectric Stimulation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesCartilage DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPhysical StimulationInvestigative Techniques

Study Officials

  • Terry L Grindstaff, PhD, PT, ATC

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 15, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(1)