Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01434966
First received: September 14, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Patellofemoral Pain Syndrome
Chondromalacia Patellae
Anterior Knee Pain Syndrome
Other: Lumbopelvic Manipulation
Other: TENS- Spine
Other: TENS- Knee

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Quadriceps force output and activation [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Knee pain during exercise [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
    Participants will perform three common exercises which include going up a step (20 cm), going down a step (20 cm) and squatting. Pain during activity will be assessed using a visual analog scale (VAS).


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbopelvic Manipulation
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
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 Names:
  • Grade V mobilization
  • High velocity, low amplitude thrust mobilization
Experimental: TENS- Spine
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
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 Names:
  • Transcutaneous electrical nerve stimulation (TENS)
  • Electrical stimulation
Experimental: TENS- Knee
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
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 Names:
  • Transcutaneous electrical nerve stimulation (TENS)
  • Electrical stimulation

Detailed Description:

Interventions for PFPS usually focus on strengthening the quadriceps muscle and hip musculature. It is suggest that intervention programs specifically address muscle inhibition beyond typical strengthening exercises. To specifically address decreased muscle activation transcutaneous electrical neuromuscular stimulation (TENS), applied to the knee, has been shown to reduce pain and increase muscle activation in individuals with knee osteoarthritis. Interventions including joint manipulation applied at distant sites, such as the lumbopelvic region have also been shown to increase muscle activation following intervention in individuals with PFPS, but the duration of effect is unknown. It is hypothesized that interventions which alter spinal afferent signals may have an effect on efferent motor output. Since the lumbopelvic region and the knee joint share common nerve root levels it is possible that interventions applied to either site may influence efferent motor output to the quadriceps muscle. The magnitude and duration of this effect is unknown.

Both TENS and lumbopelvic manipulation have also been shown to reduce pain during exercise in individuals with knee joint pathology. This study would better determine the magnitude of effective pain reduction between interventions applied at the knee joint and at a distant site, the lumbopelvic region.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434966

Contacts
Contact: Terry L Grindstaff, PhD, PT, ATC 402-280-5674 GrindstaffTL@creighton.edu

Locations
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68178
Contact: Terry L Grindstaff, PhD, PT, ATC    402-280-5674    GrindstaffTL@creighton.edu   
Contact: Scott Yokota       ScottYokota@creighton.edu   
Sub-Investigator: Scott T Yokota         
Sub-Investigator: Sam K Morton, MS         
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Terry L Grindstaff, PhD, PT, ATC Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01434966     History of Changes
Other Study ID Numbers: NCT11-16215
Study First Received: September 14, 2011
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Lumbopelvic Manipulation
Lumbosacral Manipulation
Sacroiliac Manipulation
TENS Spine
TENS Knee
Knee Pain
Chronic Knee Pain

Additional relevant MeSH terms:
Cartilage Diseases
Chondromalacia Patellae
Patellofemoral Pain Syndrome
Somatoform Disorders
Syndrome
Connective Tissue Diseases
Disease
Joint Diseases
Mental Disorders
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014