Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

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 description: 
      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 differences
      in time trends for the outcome variables among controls and those in the treatment groups can
      be statistically assessed. Positive results could translate into accelerated rehabilitation,
      decreased symptoms and lower medical costs with better patient outcomes.
    

Intervention name(s): Home Exercise Program (HEP); NMES; TENS
Intervention type(s): Other; Device; Device
Intervention description(s): All participants will receive a standard home-based exercise rehabilitation protocol for PFPS. HEP teaches muscle strengthening exercises and self-management strategies to prevent recurrence. This program includes sessions with the study coordinator. A handout and given a demonstration of the daily exercises to be performed at home and weekly communication from the study coordinator regarding compliance with the exercises.; To ensure consistent interventions across participants, a specified percentage of baseline maximal voluntary contraction (% MVC) will be used to determine the intensity of the training contraction. The electrical amplitude to obtain the desired intensity will be determined for each participant. Participants will train at 20-30% of MVC during weeks 1-3, 30-40% of MVC during weeks 3-6, and 40-50% of MVC during weeks 6-9. Incremental increases will be made at the 3 and 6 week clinic visits. Individualized instructions for adjusting the amplitude dial settings, with a return demonstration, will be used to maintain the appropriate percentage of MVC. During the home training sessions, participants will adjust the amplitude required to achieve the desired goal, as tolerated.; The TENS protocol consists of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone will be alternated for 9 weeks. The Active device delivers a pre-set program of pulsed electrostimulation using a patented asymmetrical simple modulated pulse (SMP) waveform. SMP delivers a group of pulses as a repeating 12-second cycle.
Other intervention name(s): KneeHAB® XP Thigh Garment; KneeHAB® XP Lead Wire TENS Applicator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other