Patellofemoral Pain SyndromeNCT02597673
Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
A study testing Home Exercise Program (HEP), NMES and TENS in people with Patellofemoral Pain Syndrome, run by University of Tennessee at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Home Exercise Program (HEP), NMES and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Blanchfield Army Community Hospital
Fort Campbell North, Kentucky, 42223
About this study
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Home Exercise Program (HEP), NMES, TENS
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise Program (HEP)Other
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.
NMESDevice
Also called KneeHAB® XP Thigh Garment
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.
TENSDevice
Also called KneeHAB® XP Lead Wire TENS Applicator
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation protocol | Active comparator | 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. Receives: Other: Home Exercise Program (HEP) |
| Self-Managed NMES Program | Experimental | 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). Receives: Other: Home Exercise Program (HEP); Device: NMES |
| Self-Managed TENS Program | Experimental | 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. Receives: Other: Home Exercise Program (HEP); Device: TENS |
| Combined NMES/TENS Program | Experimental | 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. Receives: Other: Home Exercise Program (HEP); Device: NMES; Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3, 6, and 9 weeks
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.
Measured: 0, 3, 6, and 9 weeks
Lower Extremity Strength- 30-Second Chair Stand Test
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Measured: 0, 3, 6, and 9 weeks
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).
Measured: 0, 3, 6, and 9 weeks
Lower Extremity Mobility- Forward Step-down Test
Mobility was measured by the number of step down repetitions completed in 30 seconds.
Measured: 0, 3, 6, and 9 weeks
Lower Extremity Mobility- 6-Minute Walk Test
Mobility was measured by the distance walked at a fast pace over 6-minutes.
Measured: 0, 3, 6, and 9 weeks
Secondary outcomes (5)
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.
Measured: 0, 3, 6, and 9 weeks
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.
Measured: 0, 3, 6, and 9 weeks
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.
Measured: 0, 3, 6, and 9 weeks
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.
Measured: 0, 3, 6, and 9 weeks
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.
Measured: 0, 3, 6, and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJul 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Blanchfield Army Community Hospital
- Responsible party
- Sponsor
- Investigators
- Laura A Talbot, PhD EdD RN, Principal investigator, University of Tennessee Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597673
- Sponsor's protocol ID
- HU0001-15-1-TS08 (N15-P01)
- Status last verified
- Aug 2018
- First submitted
- 5 Oct 2015
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
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.
PubMed 32248227
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
- ClinicalTrials.gov ID
- NCT02597673
- Acronym / sponsor ID
- HU0001-15-1-TS08 (N15-P01)
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Blanchfield Army Community Hospital
- Study start
- Jul 2015
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation protocol | Active comparator | Other: Home Exercise Program (HEP)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. |
| Self-Managed NMES Program | Experimental | Other: Home Exercise Program (HEP), Device: NMESNeuromuscular 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). |
| Self-Managed TENS Program | Experimental | Other: Home Exercise Program (HEP), Device: TENSTranscutaneous 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. |
| Combined NMES/TENS Program | Experimental | Other: Home Exercise Program (HEP), Device: NMES, Device: TENSThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Combined NMES/TENS Program, Self-Managed NMES Program, Self-Managed TENS Program, Standard rehabilitation protocol |
| NMESAlso: KneeHAB® XP Thigh GarmentTo 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. | Device | Combined NMES/TENS Program, Self-Managed NMES Program |
| TENSAlso: KneeHAB® XP Lead Wire TENS ApplicatorThe 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. | Device | Combined NMES/TENS Program, Self-Managed TENS Program |
Primary outcome
Lower Extremity Muscle Strength- Extension
Time frame: 0, 3, 6, and 9 weeks
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
Time frame: 0, 3, 6, and 9 weeks
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
Time frame: 0, 3, 6, and 9 weeks
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Lower Extremity Strength- Timed Stair Climb Test
Time frame: 0, 3, 6, and 9 weeks
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
Time frame: 0, 3, 6, and 9 weeks
Mobility was measured by the number of step down repetitions completed in 30 seconds.
Lower Extremity Mobility- 6-Minute Walk Test
Time frame: 0, 3, 6, and 9 weeks
Mobility was measured by the distance walked at a fast pace over 6-minutes.
5 secondary outcomes
Current Knee Pain
Time frame: 0, 3, 6, and 9 weeks
Knee Pain Following Performance Testing- 30-Second Chair Stand Test
Time frame: 0, 3, 6, and 9 weeks
Knee Pain Following Performance Testing- Stair Climb Test
Time frame: 0, 3, 6, and 9 weeks
Knee Pain Following Performance Testing- Forward Step Down Test
Time frame: 0, 3, 6, and 9 weeks
Knee Pain Following Performance Testing- 6-Minute Walk Test
Time frame: 0, 3, 6, and 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundThe 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.
- Derived from this study: PubMed 32248227Talbot 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.
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Talbot, PhD EdD RN principal investigator
University of Tennessee Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Program (HEP), NMES and TENS in people with Patellofemoral Pain Syndrome, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Muscle Strength- Extension (time frame: 0, 3, 6, and 9 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.