Patellofemoral Pain SyndromeNCT01434966
Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain
A study testing Lumbopelvic Manipulation, TENS- Spine and TENS- Knee in people with Patellofemoral Pain Syndrome and Chondromalacia Patellae, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to determine if interventions applied at a distant site, lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied locally at the knee (TENS) on quadriceps force output and activation as well as reports of pain during common exercises in individuals with… Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Chondromalacia Patellae, Anterior Knee Pain Syndrome
- What is being tested?
- Lumbopelvic Manipulation, TENS- Spine and TENS- Knee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2015
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15-50 years
- Insidious onset of patellofemoral pain lasting greater than 1 month in duration
- Unilateral or Bilateral knee pain or dysfunction with at least two of the following symptoms: patella compression, squatting, prolonged sitting, going up or down stairs, or isometric quadriceps contraction.
Who cannot join
- Participants who are outside of age range (to ensure bony maturity while reducing the prevalence of age related degenerative changes and hypomobility.)
- Ligamentous insufficiency, meniscus damage, patellar tendonitis, history of subluxation/dislocation
- Participants with traumatic spine or lower extremity injury within past 6 months
- Participants who have had previous adverse reactions to electrical stimulation (i.e. electrode burns.)
- Participants with signs indicating lumbar nerve root compression or upper motor neuron lesions (contraindication for lumbopelvic joint manipulation)
- Participants with ankylosing spondylitis (contraindication for lumbopelvic manipulation)
Show all 13Show fewer
- Participants with spinal cord disease or cauda equina (contraindication for lumbopelvic manipulation)
- Participants with osteoporosis (contraindication for lumbopelvic joint manipulation)
- Participants with rheumatoid arthritis (contraindication to lumbopelvic joint manipulation.)
- Participants who may be currently pregnant. (contraindication for electrical stimulation and lumbopelvic joint manipulation.)
- Participants who have a demand-type cardiac pacemaker (contraindication for electrical stimulation)
- Participants with diagnosis of cancer (current cancer is a contraindication for electrical stimulation and relative contraindication for lumbopelvic joint manipulation)
- Participants who are unable to give consent or are unable to understand procedures of experiment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if interventions applied at a distant site, lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied locally at the knee (TENS) on quadriceps force output and activation as well as reports of pain during common exercises in individuals with PFPS.
Read the detailed description
Interventions for PFPS usually focus on strengthening the quadriceps muscle and hip musculature. It is suggest that intervention programs specifically address muscle inhibition beyond typical strengthening exercises. To specifically address decreased muscle activation transcutaneous electrical neuromuscular stimulation (TENS), applied to the knee, has been shown to reduce pain and increase muscle activation in individuals with knee osteoarthritis. Interventions including joint manipulation applied at distant sites, such as the lumbopelvic region have also been shown to increase muscle activation following intervention in individuals with PFPS, but the duration of effect is unknown. It is hypothesized that interventions which alter spinal afferent signals may have an effect on efferent motor output. Since the lumbopelvic region and the knee joint share common nerve root levels it is possible that interventions applied to either site may influence efferent motor output to the quadriceps muscle. The magnitude and duration of this effect is unknown.
Both TENS and lumbopelvic manipulation have also been shown to reduce pain during exercise in individuals with knee joint pathology. This study would better determine the magnitude of effective pain reduction between interventions applied at the knee joint and at a distant site, the lumbopelvic region.
- Being tested
- Lumbopelvic Manipulation, TENS- Spine, TENS- Knee
- Keywords
- Lumbopelvic Manipulation, Lumbosacral Manipulation, Sacroiliac Manipulation, TENS Spine, TENS Knee, Knee Pain, Chronic Knee Pain
- Medical subject headings
- Patellofemoral Pain Syndrome, Chondromalacia Patellae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic ManipulationOther
Also called Grade V mobilization, High velocity, low amplitude thrust mobilization
The lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual.
TENS- SpineOther
Also called Transcutaneous electrical nerve stimulation (TENS), Electrical stimulation
The TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.
TENS- KneeOther
Also called Transcutaneous electrical nerve stimulation (TENS), Electrical stimulation
The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| Lumbopelvic Manipulation | Experimental | The lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual. Receives: Other: Lumbopelvic Manipulation |
| TENS- Spine | Experimental | The TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off. Receives: Other: TENS- Spine |
| TENS- Knee | Experimental | The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off. Receives: Other: TENS- Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps force output and activation
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.
Measured: Single Study Visit
Secondary outcomes (1)
Knee pain during exercise
Participants will perform three common exercises which include going up a step (20 cm), going down a step (20 cm) and squatting. Pain during activity will be assessed using a visual analog scale (VAS).
Measured: Single Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PhD, PT, ATC, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434966
- Sponsor's protocol ID
- NCT11-16215
- Status last verified
- Dec 2015
- First submitted
- 14 Sep 2011
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT01434966
- Acronym / sponsor ID
- NCT11-16215
- Keywords
- Lumbopelvic Manipulation, Lumbosacral Manipulation, Sacroiliac Manipulation, TENS Spine, TENS Knee, Knee Pain, Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Sep 2011 (estimated)
- 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 determine if interventions applied at a distant site, lumbopelvic region (manipulation and TENS), have a similar effect as interventions applied locally at the knee (TENS) on quadriceps force output and activation as well as reports of pain during common exercises in individuals with PFPS.
Detailed description
Interventions for PFPS usually focus on strengthening the quadriceps muscle and hip musculature. It is suggest that intervention programs specifically address muscle inhibition beyond typical strengthening exercises. To specifically address decreased muscle activation transcutaneous electrical neuromuscular stimulation (TENS), applied to the knee, has been shown to reduce pain and increase muscle activation in individuals with knee osteoarthritis. Interventions including joint manipulation applied at distant sites, such as the lumbopelvic region have also been shown to increase muscle activation following intervention in individuals with PFPS, but the duration of effect is unknown. It is hypothesized that interventions which alter spinal afferent signals may have an effect on efferent motor output. Since the lumbopelvic region and the knee joint share common nerve root levels it is possible that interventions applied to either site may influence efferent motor output to the quadriceps muscle. The magnitude and duration of this effect is unknown.
Both TENS and lumbopelvic manipulation have also been shown to reduce pain during exercise in individuals with knee joint pathology. This study would better determine the magnitude of effective pain reduction between interventions applied at the knee joint and at a distant site, the lumbopelvic region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbopelvic Manipulation | Experimental | Other: Lumbopelvic ManipulationThe lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual. |
| TENS- Spine | Experimental | Other: TENS- SpineThe TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off. |
| TENS- Knee | Experimental | Other: TENS- KneeThe TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 15-50 years
- Insidious onset of patellofemoral pain lasting greater than 1 month in duration
- Unilateral or Bilateral knee pain or dysfunction with at least two of the following symptoms: patella compression, squatting, prolonged sitting, going up or down stairs, or isometric quadriceps contraction.
Key exclusion criteria (13 listed)
- Participants who are outside of age range (to ensure bony maturity while reducing the prevalence of age related degenerative changes and hypomobility.)
- Ligamentous insufficiency, meniscus damage, patellar tendonitis, history of subluxation/dislocation
- Participants with traumatic spine or lower extremity injury within past 6 months
- Participants who have had previous adverse reactions to electrical stimulation (i.e. electrode burns.)
- Participants with signs indicating lumbar nerve root compression or upper motor neuron lesions (contraindication for lumbopelvic joint manipulation)
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 |
|---|---|---|
| Lumbopelvic ManipulationAlso: Grade V mobilization, High velocity, low amplitude thrust mobilizationThe lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual. | Other | Lumbopelvic Manipulation |
| TENS- SpineAlso: Transcutaneous electrical nerve stimulation (TENS), Electrical stimulationThe TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off. | Other | TENS- Spine |
| TENS- KneeAlso: Transcutaneous electrical nerve stimulation (TENS), Electrical stimulationThe TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off. | Other | TENS- Knee |
Primary outcome
Quadriceps force output and activation
Time frame: Single Study Visit
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.
1 secondary outcome
Knee pain during exercise
Time frame: Single Study Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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.
Terry L Grindstaff, PhD, PT, ATC principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbopelvic Manipulation, TENS- Spine and TENS- Knee in people with Patellofemoral Pain Syndrome and Chondromalacia Patellae, run by Creighton University 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 3 inclusion and 13 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 14 Dec 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quadriceps force output and activation (time frame: Single Study Visit). 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 14 Dec 2015.