Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lumbopelvic Manipulation

TENS- Spine

TENS- Knee

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Lumbopelvic Manipulation, Lumbosacral Manipulation, Sacroiliac Manipulation, TENS Spine, TENS Knee, Knee Pain, Chronic Knee Pain

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)
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.

Sites / Locations

Creighton University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Lumbopelvic Manipulation

TENS- Spine

TENS- Knee

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01434966

First Posted

September 14, 2011

Last Updated

December 10, 2015

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT01434966

Brief Title

Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain

Official Title

Changes in Quadriceps Function Following Local or Distant Interventions in Individuals With Patellofemoral Pain

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creighton University

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

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

Patellofemoral Pain Syndrome, Chondromalacia Patellae, Anterior Knee Pain Syndrome

Keywords

Lumbopelvic Manipulation, Lumbosacral Manipulation, Sacroiliac Manipulation, TENS Spine, TENS Knee, Knee Pain, Chronic Knee Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lumbopelvic Manipulation

Arm Type

Experimental

Arm Description

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.

Arm Title

TENS- Spine

Arm Type

Experimental

Arm Description

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.

Arm Title

TENS- Knee

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Lumbopelvic Manipulation

Other Intervention Name(s)

Grade V mobilization, High velocity, low amplitude thrust mobilization

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

TENS- Spine

Other Intervention Name(s)

Transcutaneous electrical nerve stimulation (TENS), Electrical stimulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

TENS- Knee

Other Intervention Name(s)

Transcutaneous electrical nerve stimulation (TENS), Electrical stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Quadriceps force output and activation

Description

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.

Time Frame

Single Study Visit

Secondary Outcome Measure Information:

Title

Knee pain during exercise

Description

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).

Time Frame

Single Study Visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terry L Grindstaff, PhD, PT, ATC

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68178

Country

United States

Patellofemoral Pain Syndrome, Chondromalacia Patellae, Anterior Knee Pain Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial