Anterior Knee Pain SyndromeNCT06536426
Knee Isometric Program (KIP) Home Exercise Programs (HEP) Physical Therapy (PT) Study
A study testing Knee Isometric Program (KIP) in people with Anterior Knee Pain Syndrome, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline [CPG] - Academy of Orthopedic Physical Therapy). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Knee Isometric Program (KIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accept all provisions of the study and agree to complete the program in its entirety
- Age between 18-65
- Complaint of anterior knee pain for at least 4 weeks, but no more than 12 months
- Prescribed referral for physical therapy for their knee(s) from one of the investigators
Who cannot join
- Potential participant does not agree to comply with study protocols or does not wish to be subjected to a random group allocation
- Any neurological or degenerative musculoskeletal condition involving the lower extremities
- Ages outside of 18-65
- Surgical history or fracture within the last 12 months on the affected extremity(ies)
- Currently participating in a structured strength training program
- Inability to access clinic for data collection or follow-up sessions
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- Significant anatomical anomaly or limb alignment disorder as diagnosed by medical professional (femoral anteversion/retroversion, patella alta/baja, varus/valgus deformities, patella deformities/fractures, osteotomy procedures, limb lengthening procedures)
- Significant cartilage damage as diagnosed by medical professional (grade 3+ chondral defects of the femur or patella)
- Any other condition that limits full weight bearing of the affected lower extremity(ies)
- Vulnerable populations
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
Official title: Effectiveness of a Knee Isometric Program on Reducing Anterior Knee Pain and Improving Functional Outcomes
The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline [CPG] - Academy of Orthopedic Physical Therapy).
Read the detailed description
Participants will be randomly allocated into the KIP or control intervention via spreadsheet randomization algorithm at the time of consenting. Each patient will have equivalent experiences for the duration of the study regardless of allocation. Time spent with the physical therapist, daily length of exercise program, outcome measures recorded, and home education materials will all be similar for each group. Participants will be asked to refrain from any outside forms of lower extremity strengthening or training. Usage of pain medication (including over-the-counter and prescription drugs) will be documented in the pain journal. Proper use of the pain journal will be explained during consent and again at the initial intake session.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Knee Isometric Program (KIP)
- 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.
Knee Isometric Program (KIP)Behavioural
The KIP physical therapy protocol follows the schedule outlined below:
- Session 1 (Completed 4-5 days/week including HEP): Double Leg wall sit 3x30 seconds, Double Leg glute bridge hold 3x30 seconds, Single Leg Stance hold 3x1 minutes, Lunge hold 3x1 minutes
- Session 2 (Completed 4-5 days/week including HEP): Single Leg wall sit 3x20 seconds, Single Leg glute bridge hold 3x20 seconds, Single Leg stance hold 2x1.5 minutes, Lunge hold 2x1.5 minutes
- Session 3 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes
- Session 4 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes
| Study group | Role | What they receive |
|---|---|---|
| Knee Isometric Program (KIP) - Intervention | Experimental | This group will incorporate the KIP protocol, which is a modified physical therapy regimen that is less time-intensive than the gold standard counterpart. Typical structured/skilled physical therapy occurs over the course of 4-8 weeks with 1-2 visits per week to establish improved lower extremity muscle strength, education, and improve gross function. Home exercise programs (HEP) are utilized in tandem with physical therapy visits so that patients are completing interventions 4-5 days per week. Long-term maintenance is generally provided via a refined comprehensive HEP on completion and discharge from formal physical therapy. Receives: Behavioral: Knee Isometric Program (KIP) |
| Patellofemoral Clinical Practice Guideline (CPG) - Control | No intervention | This group will incorporate the standard of care physical therapy regimen which includes a specific and structured combination of quadriceps and gluteal strengthening as defined in the patellofemoral pain clinical practice guideline. Typical structured/skilled physical therapy occurs over the course of 4-8 weeks with 1-2 visits per week to establish improved lower extremity muscle strength, education, and improve gross function. Home exercise programs (HEP) are utilized in tandem with physical therapy visits so that patients are completing interventions 4-5 days per week. Long-term maintenance is generally provided via a refined comprehensive HEP on completion and discharge from formal physical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain
Participants will complete the Numerical Pain Rating Scale (NPRS) in a pain and medication journal in order to subjectively rate their pain over over 4-5 days between each session, except for after session 4 in which they will document twice a day for 20 days. The NPRS rates pain on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable, and subjects will reflect pain pre and post physical therapy. Additionally, they will be asked to reflect any pain medication that they take on a given day.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks
Knee Function
Participants will complete the lower extremity functional scale (LEFS) at session 1 and at session 5 (one month follow up visit after completing physical therapy) in order to determine any change in knee function across those time periods. The LEFS is a 20 question survey that asks about a person's ability to perform everyday tasks and each question is scored on a scale from 0 to 4 with 0 being extreme difficulty or unable to perform activity and 4 being no difficulty. These responses are then summed to get a total score out of 80 maximum points, and the lower the score, the greater the disability.
Measured: Baseline, 12 weeks
Objective Muscular Strength Performance
Participants will have their quad strength measured using a handheld dynamometer (HHD) at session 1 and session 5 of their study visits in order to determine with that data how muscular strength changes following each physical therapy regimen.
Measured: Baseline, 12 weeks
Functional Stability
Functional stability will be assessed at sessions 1 and 5 to determine each participant's dynamic balance, and it will be used to assess anterior reach specifically. This test has the participant stand on one leg while reaching out in 3 different directions with the other lower extremity, and thus measures strength, stability, and balance in multiple directions. The composite score is calculated by summing the three reach directions. Higher scores reflect better outcomes.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start2 Aug 2024
- Primary completion9 Jul 2025
- Study completion26 Sep 2025
Why it stopped: The study was determined to be too difficult to run following the enrollment of a few participants over the course of a year. No preliminary or final results were obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536426
- Sponsor's protocol ID
- PRO00037838
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Knee Isometric Program on Reducing Anterior Knee Pain and Improving Functional Outcomes
- ClinicalTrials.gov ID
- NCT06536426
- Acronym / sponsor ID
- PRO00037838
- Conditions
- Anterior Knee Pain Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was determined to be too difficult to run following the enrollment of a few participants over the course of a year. No preliminary or final results were obtained.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline [CPG] - Academy of Orthopedic Physical Therapy).
Detailed description
Participants will be randomly allocated into the KIP or control intervention via spreadsheet randomization algorithm at the time of consenting. Each patient will have equivalent experiences for the duration of the study regardless of allocation. Time spent with the physical therapist, daily length of exercise program, outcome measures recorded, and home education materials will all be similar for each group. Participants will be asked to refrain from any outside forms of lower extremity strengthening or training. Usage of pain medication (including over-the-counter and prescription drugs) will be documented in the pain journal. Proper use of the pain journal will be explained during consent and again at the initial intake session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Isometric Program (KIP) - Intervention | Experimental | Behavioral: Knee Isometric Program (KIP)This group will incorporate the KIP protocol, which is a modified physical therapy regimen that is less time-intensive than the gold standard counterpart. Typical structured/skilled physical therapy occurs over the course of 4-8 weeks with 1-2 visits per week to establish improved lower extremity muscle strength, education, and improve gross function. Home exercise programs (HEP) are utilized in tandem with physical therapy visits so that patients are completing interventions 4-5 days per week. Long-term maintenance is generally provided via a refined comprehensive HEP on completion and discharge from formal physical therapy. |
| Patellofemoral Clinical Practice Guideline (CPG) - Control | No intervention | –This group will incorporate the standard of care physical therapy regimen which includes a specific and structured combination of quadriceps and gluteal strengthening as defined in the patellofemoral pain clinical practice guideline. Typical structured/skilled physical therapy occurs over the course of 4-8 weeks with 1-2 visits per week to establish improved lower extremity muscle strength, education, and improve gross function. Home exercise programs (HEP) are utilized in tandem with physical therapy visits so that patients are completing interventions 4-5 days per week. Long-term maintenance is generally provided via a refined comprehensive HEP on completion and discharge from formal physical therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Accept all provisions of the study and agree to complete the program in its entirety
- Age between 18-65
- Complaint of anterior knee pain for at least 4 weeks, but no more than 12 months
- Prescribed referral for physical therapy for their knee(s) from one of the investigators
Key exclusion criteria (10 listed)
- Potential participant does not agree to comply with study protocols or does not wish to be subjected to a random group allocation
- Any neurological or degenerative musculoskeletal condition involving the lower extremities
- Ages outside of 18-65
- Surgical history or fracture within the last 12 months on the affected extremity(ies)
- Currently participating in a structured strength training program
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 |
|---|---|---|
| Knee Isometric Program (KIP)The KIP physical therapy protocol follows the schedule outlined below: * Session 1 (Completed 4-5 days/week including HEP): Double Leg wall sit 3x30 seconds, Double Leg glute bridge hold 3x30 seconds, Single Leg Stance hold 3x1 minutes, Lunge hold 3x1 minutes * Session 2 (Completed 4-5 days/week including HEP): Single Leg wall sit 3x20 seconds, Single Leg glute bridge hold 3x20 seconds, Single Leg stance hold 2x1.5 minutes, Lunge hold 2x1.5 minutes * Session 3 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes * Session 4 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes | Behavioural | Knee Isometric Program (KIP) - Intervention |
Primary outcome
Subjective Pain
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks
Participants will complete the Numerical Pain Rating Scale (NPRS) in a pain and medication journal in order to subjectively rate their pain over over 4-5 days between each session, except for after session 4 in which they will document twice a day for 20 days. The NPRS rates pain on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable, and subjects will reflect pain pre and post physical therapy. Additionally, they will be asked to reflect any pain medication that they take on a given day.
Knee Function
Time frame: Baseline, 12 weeks
Participants will complete the lower extremity functional scale (LEFS) at session 1 and at session 5 (one month follow up visit after completing physical therapy) in order to determine any change in knee function across those time periods. The LEFS is a 20 question survey that asks about a person's ability to perform everyday tasks and each question is scored on a scale from 0 to 4 with 0 being extreme difficulty or unable to perform activity and 4 being no difficulty. These responses are then summed to get a total score out of 80 maximum points, and the lower the score, the greater the disability.
Objective Muscular Strength Performance
Time frame: Baseline, 12 weeks
Participants will have their quad strength measured using a handheld dynamometer (HHD) at session 1 and session 5 of their study visits in order to determine with that data how muscular strength changes following each physical therapy regimen.
Functional Stability
Time frame: Baseline, 12 weeks
Functional stability will be assessed at sessions 1 and 5 to determine each participant's dynamic balance, and it will be used to assess anterior reach specifically. This test has the participant stand on one leg while reaching out in 3 different directions with the other lower extremity, and thus measures strength, stability, and balance in multiple directions. The composite score is calculated by summing the three reach directions. Higher scores reflect better outcomes.
Results and safety
The study was stopped early (reason given: The study was determined to be too difficult to run following the enrollment of a few participants over the course of a year. No preliminary or final results were obtained.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Isometric Program (KIP) in people with Anterior Knee Pain Syndrome, run by The Methodist Hospital Research Institute 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Oct 2025. 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?
The study was stopped early (reason given: The study was determined to be too difficult to run following the enrollment of a few participants over the course of a year. No preliminary or final results were obtained.). Results are not available in the source record.
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?
Subjective Pain (time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2025.