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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Exercise Program (HEP)
NMES
TENS
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Blanchfield Army Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Standard rehabilitation protocol

Self-Managed NMES Program

Self-Managed TENS Program

Combined NMES/TENS Program

Arm Description

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. 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.

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).

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.

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.

Outcomes

Primary Outcome Measures

Lower Extremity Muscle Strength- Extension
The NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed 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.
Lower Extremity Muscle Strength- Flexion
The NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed 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.
Lower Extremity Strength- 30-Second Chair Stand Test
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Lower Extremity Strength- Timed Stair Climb Test
Strength, balance, and power were measured by the number seconds it took to ascend and descend 4 steps (6 in rise, 11.5 in run).
Lower Extremity Mobility- Forward Step-down Test
Mobility was measured by the number of step down repetitions completed in 30 seconds.
Lower Extremity Mobility- 6-Minute Walk Test
Mobility was measured by the distance walked at a fast pace over 6-minutes.

Secondary Outcome Measures

Current Knee Pain
Current Knee Pain was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Knee pain intensity after the 30-Second Chair Stand Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Knee Pain Following Performance Testing- Stair Climb Test
Knee pain intensity after the Stair Climb Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Knee Pain Following Performance Testing- Forward Step Down Test
Knee pain intensity after the Forward Step Down Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Knee Pain Following Performance Testing- 6-Minute Walk Test
Knee pain intensity after the 6-Minute Walk Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.

Full Information

First Posted
October 5, 2015
Last Updated
September 9, 2020
Sponsor
University of Tennessee
Collaborators
Blanchfield Army Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02597673
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
Blanchfield Army Community Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard rehabilitation protocol
Arm Type
Active Comparator
Arm Description
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. 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.
Arm Title
Self-Managed NMES Program
Arm Type
Experimental
Arm Description
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).
Arm Title
Self-Managed TENS Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined NMES/TENS Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home Exercise Program (HEP)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NMES
Other Intervention Name(s)
KneeHAB® XP Thigh Garment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
KneeHAB® XP Lead Wire TENS Applicator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower Extremity Muscle Strength- Extension
Description
The NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed 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.
Time Frame
0, 3, 6, and 9 weeks
Title
Lower Extremity Muscle Strength- Flexion
Description
The NMMT is a handheld device which measures knee extensor (KE) and flexor (KF) muscle strength. The measurement of KE strength on the PFPS leg is reported. For each test, participants performed 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.
Time Frame
0, 3, 6, and 9 weeks
Title
Lower Extremity Strength- 30-Second Chair Stand Test
Description
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Time Frame
0, 3, 6, and 9 weeks
Title
Lower Extremity Strength- Timed Stair Climb Test
Description
Strength, balance, and power were measured by the number seconds it took to ascend and descend 4 steps (6 in rise, 11.5 in run).
Time Frame
0, 3, 6, and 9 weeks
Title
Lower Extremity Mobility- Forward Step-down Test
Description
Mobility was measured by the number of step down repetitions completed in 30 seconds.
Time Frame
0, 3, 6, and 9 weeks
Title
Lower Extremity Mobility- 6-Minute Walk Test
Description
Mobility was measured by the distance walked at a fast pace over 6-minutes.
Time Frame
0, 3, 6, and 9 weeks
Secondary Outcome Measure Information:
Title
Current Knee Pain
Description
Current Knee Pain was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Time Frame
0, 3, 6, and 9 weeks
Title
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Description
Knee pain intensity after the 30-Second Chair Stand Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Time Frame
0, 3, 6, and 9 weeks
Title
Knee Pain Following Performance Testing- Stair Climb Test
Description
Knee pain intensity after the Stair Climb Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Time Frame
0, 3, 6, and 9 weeks
Title
Knee Pain Following Performance Testing- Forward Step Down Test
Description
Knee pain intensity after the Forward Step Down Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Time Frame
0, 3, 6, and 9 weeks
Title
Knee Pain Following Performance Testing- 6-Minute Walk Test
Description
Knee pain intensity after the 6-Minute Walk Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Time Frame
0, 3, 6, and 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study will be open to all active duty personal who are: diagnosed with knee pain, categorized as anterior or retropatellar in one or both knees; 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; military service member at the time of diagnosis; age ≥18 and <45 years; and 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 Fracture or injury to external knee structures such that knee extension or flexion is impaired; 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; Previous knee surgeries (i.e., tibiofemoral, patellofemoral) excluding knee arthroscopy; Knee instability or recurrent patella dislocation or subluxation; Inability or unwillingness to participate in a home exercise program or strengthening program; Inability to speak and/or read English; Reduced sensory perception in the lower extremities; Pregnancy; Vision impairment, where participant is classified as legally blind; Unwillingness to accept random assignment; or A score of 23 or greater on the Center for Epidemiological Studies-Depression scale (CES-D).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Talbot, PhD EdD RN
Organizational Affiliation
University of Tennessee Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blanchfield Army Community Hospital
City
Fort Campbell North
State/Province
Kentucky
ZIP/Postal Code
42223
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
PubMed Identifier
32248227
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.
Results Reference
derived

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

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