Clinical Trial: Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty

Brief Summary:

The overall objective of this project is to compare the three home-managed treatment regimens for PFPS: neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), and NMES combined with TENS to a standard home exercise program (HEP). Each of the three treatment arms will be supplemented by HEP and compared to a group receiving standard HEP alone. The central hypothesis is that the combination of NMES with TENS will show significantly greater improvements in muscle strength, mobility, pain, daily activity and quality of life (QOL) than HEP alone.

The investigators are examining: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving lower extremity muscle strength, physical activity, mobility, pain, and quality of life; 2) lower extremity muscle strength, physical activity, mobility, pain, and quality of life differ significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to lower extremity muscle strength, physical activity, mobility, pain, and quality of life.


Detailed Summary: Patellofemoral pain syndrome (PFPS) is the most common diagnosis among active duty military presenting with knee pain in the military ambulatory care setting. The incidence of PFPS has shown a striking increase of >11.3% over the last 4 years, affecting work performance, limiting activity, and impacting military deployment health. The investigators have shown that home-based neuromuscular electrical stimulation (NMES) is safe, portable, easy-to-use and improves quadriceps muscle strength with some pain relief. NMES and transcutaneous electrical nerve stimulation (TENS) devices are widely used by warfighters in the theatre of operation for knee problems. The overall objective of this project is to compare three home-managed treatment regimens for PFPS: NMES, TENS, and NMES combined with TENS to a standard home exercise program (HEP). The central hypothesis is that the combination of NMES with TENS will show significantly greater improvements in muscle strength, mobility, pain, daily activity and quality of life (QOL) than HEP alone. The rationale for this study is that increasing muscle strength and decreasing pain will significantly improve mobility, physical activity and QOL. Such outcomes will ultimately result in improved deployability, retention of military personnel and decreased economic costs in this population. The specific aims are to determine whether the three treatment regimens are significantly more efficacious than standard HEP for improving muscle strength, physical activity, mobility, QOL and symptoms of PFPS including pain. After consent and baseline testing, the investigators will randomly assign active duty male and female subjects, ages 18 to <45, (n=136) with PFPS to one of the four groups. Each of the three treatment arms will be supplemented by HEP and compared to a group receiving standard HEP alone. All groups will receive 9 weeks of home therapy. Using GEE methods, the investigators will build longitudinal regression models so that di
Sponsor: University of Tennessee

Current Primary Outcome:

  • Change from baseline lower extremity muscle strength at 3, 6, and 9 weeks as measured using the Nicholas Manual Muscle Tester (MMT) [ Time Frame: 0, 3, 6, 9 Weeks ]
    The NMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. Three locations (per limb) for the strength measurement will be taken using the MMT. For each test, participants will perform three maximal efforts holding each contraction for 4 seconds, separated by 30-second rest; the highest value of the three trials will be accepted in kilograms.
  • Change from baseline physical activity at 3, 6, and 9 weeks as measured by the Fitbit Charge accelerometer. [ Time Frame: 0, 3, 6, 9 Weeks ]
    The Charge is a wrist-worn three-axis accelerometer that measures steps walked, distance traveled, energy expenditure and floors climbed. The frequency, duration, intensity and patterns of movement are recorded. Baseline data will be ascertained by wearing the Charge for 3 days while maintaining a typical activity pattern. Subsequently, the device will be worn daily for 9 weeks.
  • Change from baseline mobility at 3, 6, and 9 weeks as measured by a timed stair climb (TSC). [ Time Frame: 0, 3, 6, 9 Weeks ]
    The TSC tests the functional activity of stair climbing. Measures are inversely correlated to quadriceps muscle strength and cardiovascular capacity. The test will begin with participants ascending up four steps (6-inch rise, 11.5-inch run) to a 30-inch square platform, and then descending to the bottom of the stairs. Participants will climb the stairs at a self-selected pace using the handrails if necessary. Each participant will complete two complete r

    Original Primary Outcome:

    • Change from baseline lower extremity muscle strength at 3, 6, and 9 weeks as measured using the Nicholas Manual Muscle Tester (MMT) [ Time Frame: 0, 3, 6, 9 Weeks ]

      The NMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. Three locations (per limb) for the strength measurement will be taken using the MMT. For each test, participants will perform three maximal efforts holding each contraction for 4 seconds, separated by 30-second rest; the highest value of the three trials will be accepted in kilograms.

      We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving lower extremity muscle strength; 2) lower extremity muscle strength differs significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to lower extremity muscle strength.

    • Change from baseline physical activity at 3, 6, and 9 weeks as measured by the Fitbit Charge accelerometer. [ Time Frame: 0, 3, 6, 9 Weeks ]

      The Charge is a wrist-worn three-axis accelerometer that measures steps walked, distance traveled, energy expenditure and floors climbed. The frequency, duration, intensity and patterns of movement are recorded. Baseline data will be ascertained by wearing the Charge for 3 days while maintaining a typical activity pattern. Subsequently, the device will be worn daily for 9 weeks.

      We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significa

      Current Secondary Outcome:

      • Change from baseline symptoms of PFPS at 3, 6, and 9 weeks as measured by the Kujala Anterior Knee Pain Scale (KAKPS). [ Time Frame: 0, 3, 6, 9 Weeks ]
        The KAKPS is a 13-item knee specific self-report questionnaire. Scores range from 0-100 (higher scores indicate better performance). Change in baseline symptoms is assessed as the change in score.
      • Change from baseline symptoms of PFPS at 3, 6, and 9 weeks as measured by the International Knee Documentation Committee (IKDC) subjective knee form. [ Time Frame: 0, 3, 6, 9 Weeks ]
        The IKDC subjective knee form is a a well standardized outcomes questionnaire that is knee-specific and assesses patients with various knee disorders. The 18-item instrument assesses symptoms, function and level of sports participation for those with an injured knee. Higher scores indicate higher functioning and reduced symptoms. Change in symptoms is assessed as the change in score.
      • Change from baseline symptoms of PFPS at 3, 6, and 9 weeks as measured by the Visual Analog Scale (VAS) of pain. [ Time Frame: 0, 3, 6, 9 Weeks ]
        The VAS pain scale will be used to assess pain at rest and after activity. . Participants will complete this scale following the stair climb, step down test, 6-minute walk and the chair rise test. This VAS pain subscale is a 100-mm horizontal line index with descriptive anchors at each end. At the far left (0.0 cm) is "no pain" and at the far right (10 cm) is "worst possible pain". The participant is instructed to place a vertical line at some point between the anchors to describe his/her level of pain. The VAS pain scale shows high correlations with acute pain levels. Change in symptoms is assessed as the change in reported pain level.
      • Change from baseline Quality of Life (QOL) at 3, 6, and 9 weeks as measured by the Medical Outcomes Study 36-item Short Form Health Survey (SF-36). [ Time Frame: 0, 3, 6, 9 Weeks ]
        The SF-36 multidimensional scale has two summary scores for physical and mental health as well as eight subscale scores. Each subscale score is transformed into a 0-100 score, with a higher score corresponding with less disability. Change in QOL is assessed as the change in score.
      • Change from baseline Quality of Life (QOL) at 3, 6, and 9 weeks as measured by the Centers for Epidemiologic Studies Depression instrument (CES-D) [ Time Frame: 0, 3, 6, 9 Weeks ]
        The CES-D has 20 questions measuring symptoms of depression in 9 areas. Possible scores range from 0-60. Categorization of results ranges from No clinical significance (<16 total score) to Meets Criteria for Major Depressive Episode (depends on responses to specific categories). Change in QOL is assessed as change in score.


      Original Secondary Outcome:

      • Change from baseline symptoms of PFPS at 3, 6, and 9 weeks as measured by the Kujala Anterior Knee Pain Scale (KAKPS). [ Time Frame: 0, 3, 6, 9 Weeks ]

        The KAKPS is a 13-item knee specific self-report questionnaire. Scores range from 0-100 (higher scores indicate better performance). Change in baseline symptoms is assessed as the change in score.

        We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving symptoms of PFPS; 2) symptoms of PFPS differ significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to symptoms of PFPS.

      • Change from baseline symptoms of PFPS at 3, 6, and 9 weeks as measured by the International Knee Documentation Committee (IKDC) subjective knee form. [ Time Frame: 0, 3, 6, 9 Weeks ]

        The IKDC subjective knee form is a a well standardized outcomes questionnaire that is knee-specific and assesses patients with various knee disorders. The 18-item instrument assesses symptoms, function and level of sports participation for those with an injured knee. Higher scores indicate higher functioning and reduced symptoms. Change in symptoms is assessed as the change in score.

        We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving symptoms of PFPS; 2) symptoms of PFPS differ significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to symptoms of PFPS.

      • Change from baseline symptoms of PFPS at 3, 6, and 9 weeks as measured by the Visual Analog Scale (VAS) of pain. [ Time Frame: 0, 3, 6, 9 Weeks ]

        The VAS pain scale will be used to assess pain at rest and after activity. . Participants will complete this scale following the stair climb, step down test, 6-minute walk and the chair rise test. This VAS pain subscale is a 100-mm horizontal line index with descriptive anchors at each end. At the far left (0.0 cm) is "no pain" and at the far right (10 cm) is "worst possible pain". The participant is instructed to place a vertical line at some point between the anchors to describe his/her level of pain. The VAS pain scale shows high correlations with acute pain levels. Change in symptoms is assessed as the change in reported pain level.

        We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving symptoms of PFPS; 2) symptoms of PFPS differ significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to symptoms of PFPS.

      • Change from baseline Quality of Life (QOL) at 3, 6, and 9 weeks as measured by the Medical Outcomes Study 36-item Short Form Health Survey (SF-36). [ Time Frame: 0, 3, 6, 9 Weeks ]

        The SF-36 multidimensional scale has two summary scores for physical and mental health as well as eight subscale scores. Each subscale score is transformed into a 0-100 score, with a higher score corresponding with less disability. Change in QOL is assessed as the change in score.

        We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving quality of life (QOL); 2) quality of life (QOL) differs significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to quality of life (QOL).

      • Change from baseline Quality of Life (QOL) at 3, 6, and 9 weeks as measured by the Centers for Epidemiologic Studies Depression instrument (CES-D) [ Time Frame: 0, 3, 6, 9 Weeks ]

        The CES-D has 20 questions measuring symptoms of depression in 9 areas. Possible scores range from 0-60. Categorization of results ranges from No clinical significance (<16 total score) to Meets Criteria for Major Depressive Episode (depends on responses to specific categories). Change in QOL is assessed as change in score.

        We are examining the outcome measure to determine if: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving quality of life (QOL); 2) quality of life (QOL) differs significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to quality of life (QOL).



      Information By: University of Tennessee

      Dates:
      Date Received: October 5, 2015
      Date Started: July 2015
      Date Completion: June 2018
      Last Updated: June 29, 2016
      Last Verified: June 2016