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

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ClinicalTrials.gov Identifier: NCT02597673
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Blanchfield Army Community Hospital
Information provided by (Responsible Party):
University of Tennessee

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.


Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Home Exercise Program (HEP) Device: NMES Device: TENS Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
Study Start Date : July 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
No Intervention: Standard rehabilitation protocol
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. The HEP sessions provide the participant with a self-management framework for returning to duty following PFPS rehabilitation. The exercises are quadriceps strengthening exercises. These exercises consist of stretching exercises of the quadriceps and hamstring muscles and a combination of open chain and closed chain exercises. The combined open and closed chain exercises are active straight leg raises, quadriceps straightening, step up, and squats.
Experimental: Self-Managed NMES Program
Neuromuscular electrical stimulation (NMES). This group will receive a portable battery-operated device, KneeHAB® XP (Bio-Medical Research, Galway, Ireland) with the thigh garment. NMES training will consist of 20-minute stimulation sessions performed concurrently with the HEP for 9 weeks; each 20-minute NMES session includes a 2-minute warm-up, a 15-minute work-out and a 3-minute cool down. NMES with the thigh garment will be used as the participant is performing the home exercises of stretching and combined open and closed chain exercises. Those in the NMES group will alternate HEP alone and NMES with HEP for a total of 62 sessions (31 sessions of NMES/HEP and 31 sessions HEP alone).
Other: Home Exercise Program (HEP)
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.

Device: NMES
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.
Other Name: KneeHAB® XP Thigh Garment

Experimental: Self-Managed TENS Program
Transcutaneous electrical nerve stimulation (TENS). The TENS treatment groups will receive the battery-operated Kneehab® XP with lead wire TENS applicator system. 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 for a total of 31 TENS/HEP sessions and 31 HEP alone for a total of 62 sessions.
Other: Home Exercise Program (HEP)
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.

Device: TENS
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 Name: KneeHAB® XP Lead Wire TENS Applicator

Experimental: Combined NMES/TENS Program
The combined NMES/TENS treatment group will receive the Kneehab® XP with the conductive thigh garment and the lead wire TENS applicator. The same parameters for TENS and NMES will be used (described above). The NMES and the TENS protocol will be performed on alternating days. There will be a total of 31 NMES sessions with HEP and 31 TENS sessions with HEP for a total of 62 sessions.
Other: Home Exercise Program (HEP)
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.

Device: NMES
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.
Other Name: KneeHAB® XP Thigh Garment

Device: TENS
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 Name: KneeHAB® XP Lead Wire TENS Applicator




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The study will be open to all active duty personal who are:

  1. diagnosed with knee pain, categorized as anterior or retropatellar in one or both knees;
  2. self-reported difficulty performing at least two or more of the following activities associated with knee pain: prolonged sitting, stair climbing, running, jumping and repetitive movements such as kneeling or squatting or stooping;
  3. military service member at the time of diagnosis;
  4. age ≥18 and <45 years; and
  5. ability to provide freely given informed consent.

Exclusion Criteria:

Those who might be at risk of adverse outcomes from the study interventions will be excluded. This includes individuals with

  1. Fracture or injury to external knee structures such that knee extension or flexion is impaired;
  2. A significant co-morbid medical condition (such as severe hypertension, neurological disorder or pacemaker/defibrillator) in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
  3. Previous knee surgeries (i.e., tibiofemoral, patellofemoral) excluding knee arthroscopy;
  4. Knee instability or recurrent patella dislocation or subluxation;
  5. Inability or unwillingness to participate in a home exercise program or strengthening program;
  6. Inability to speak and/or read English;
  7. Reduced sensory perception in the lower extremities;
  8. Pregnancy;
  9. Vision impairment, where participant is classified as legally blind;
  10. Unwillingness to accept random assignment; or
  11. A score of 23 or greater on the Center for Epidemiological Studies-Depression scale (CES-D).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597673


Contacts
Contact: Laura A Talbot, PhD EdD RN (901) 448-3630 ltalbot@uthsc.edu
Contact: Zack T Solomon, DPT OCS CSCS 270-798-8103 zack.t.solomon.mil@mail.mil

Locations
United States, Kentucky
Blanchfield Army Community Hospital Recruiting
Fort Campbell North, Kentucky, United States, 42223
Contact: Zack T Solomon, DPT OCS CSCS    270-798-8103    zack.t.solomon.mil@mail.mil   
Contact: Laura Dawson, DO       laura.k.dawson.mil@mail.mil   
Sponsors and Collaborators
University of Tennessee
Blanchfield Army Community Hospital
Investigators
Principal Investigator: Laura A Talbot, PhD EdD RN University of Tennessee Health Sciences Center

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02597673     History of Changes
Other Study ID Numbers: HU0001-15-1-TS08 (N15-P01)
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases