Clinical trial NCT02597673: Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
Official title: Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Blanchfield Army Community Hospital
First posted: 2015-11-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility 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).

Primary outcomes:
measure: Lower Extremity Muscle Strength- Extension
timeFrame: 0, 3, 6, and 9 weeks
measure: Lower Extremity Muscle Strength- Flexion
timeFrame: 0, 3, 6, and 9 weeks
measure: Lower Extremity Strength- 30-Second Chair Stand Test
timeFrame: 0, 3, 6, and 9 weeks
measure: Lower Extremity Strength- Timed Stair Climb Test
timeFrame: 0, 3, 6, and 9 weeks
measure: Lower Extremity Mobility- Forward Step-down Test
timeFrame: 0, 3, 6, and 9 weeks
measure: Lower Extremity Mobility- 6-Minute Walk Test
timeFrame: 0, 3, 6, and 9 weeks
Secondary outcomes:
measure: Current Knee Pain
timeFrame: 0, 3, 6, and 9 weeks
measure: Knee Pain Following Performance Testing- 30-Second Chair Stand Test
timeFrame: 0, 3, 6, and 9 weeks
measure: Knee Pain Following Performance Testing- Stair Climb Test
timeFrame: 0, 3, 6, and 9 weeks
measure: Knee Pain Following Performance Testing- Forward Step Down Test
timeFrame: 0, 3, 6, and 9 weeks
measure: Knee Pain Following Performance Testing- 6-Minute Walk Test
timeFrame: 0, 3, 6, and 9 weeks
Other outcomes:
Locations:
city: Fort Campbell North
country: United States
facility: Blanchfield Army Community Hospital
state: Kentucky
Study officials:
affiliation: University of Tennessee Health Sciences Center
name: Laura A Talbot, PhD EdD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: The results of this study have not yet been published in a peer-reviewed journal. The registration will be updated with the full journal citation when the results are published.
citation: Talbot LA, Solomon Z, Webb L, Morrell C, Metter EJ. Electrical Stimulation Therapies for Active Duty Military with Patellofemoral Pain Syndrome: A Randomized Trial. Mil Med. 2020 Aug 14;185(7-8):e963-e971. doi: 10.1093/milmed/usaa037.