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Effects of Hip and Knee Exercises on Knee Pain in Young Adult Females With Long-standing Patellofemoral Pain

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ClinicalTrials.gov Identifier: NCT03054701
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Skovdal Rathleff, Aalborg University

Brief Summary:

Patellofemoral pain (PFP) is highly prevalent in both adolescent and adult populations and as much as 91% of those affected experience ongoing knee pain for up to 20 years after the initial diagnosis.

Exercise-based treatment focusing on strengthening the muscles around the hip and knee is usually effective when treating patient with PFP. However, this approach has proven ineffective in a subgroup of females who have suffered from PFP for multiple years.

This group was found to have a significantly lower tolerance for pressure stimuli compared to healthy controls. This indicating that central mechanisms within the nervous system rather than the problem being the knee itself.

Exercising a non-painful muscle distant to a painful part of the body has previously been effective in deceasing pain in affected area. This mechanism has been investigated in patients with long-standing musculoskeletal pain as well as healthy populations.

Related research has suggested that a possible link between patients perception of painful stimuli an the pain-reducing effect of exercise exists. As such, patients witch experienced a pain reducing effect of exercise was found to be able to tolerate more pain than before the intervention.

The aim of this study is to assess if exercising a distant non-painful muscle around the hip has a larger acute pain-reducing effect on knee pain compared to knee specific exercises in female patients with long-standing PFP.


Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Hip specific resistance exercise Other: Knee specific resistance exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: After providing informed consent the participants will determine which is their most painful knee. This limb will be marked and it will serve as the test limb throughout the study protocol. At the first step of the protocol the participants will be baseline tested with handheld and cuff pressure algometer. Secondly, participants will be randomized to either a hip or a knee exercise. Thirdly, participants will undergo the testing-procedure for the second time. Fourthly, participants will perform exercise focusing on the other joint (hip or knee). Finally, participants will undergo the testing-procedure for the last time. In order to avoid any carryover effect from the testing procedure, there will be at least 15-minutes between each of the three test sessions.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The outcome assessor will be blinded to the order of the exercises and the participants will be blinded to the study-hypothesis.
Primary Purpose: Basic Science
Official Title: The Acute Effects of Hip and Knee Exercises on Pain Sensitivity in Young Adult Females With Long-standing Patellofemoral Pain - a Randomized Crossover Study.
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sidelying hip abduction exercise

Participants will be lying on the side with both legs stretched and with their head resting on a pillow. Participants will be allowed to place their hand in front of them to fixate their body and maintain balance. The participants will be instructed to abduct their hip to 45 degrees and return to the resting position afterwards. An elastic band will be used as resistance. This exercise will be applied only on the test limb. A digital metronome will be used to maintain the pace during the exercise.

Load: 12 repetition maximum; Nr. of repetition: 12; Nr. of sets: 3; Rest between sets: 120 seconds; Time under tension: 8 seconds; Distribution of load: Concentric (3 seconds), Eccentric (3 seconds), Isometric (2 seconds).

Other: Hip specific resistance exercise
Hip specific resistance exercise

Active Comparator: Sitting knee extension exercise

Participants will be seated at the end of an examination couch with the hip and knee relaxed in a 90 degrees angel. Participants will be allowed to place their hands on the side of the couch and the stabilizing foot may have contact with the floor. The participants will be instructed to extend their knee to a 180-degree angle and return to the resting position afterwards. An elastic band will be used as resistance. This exercise will be applied only on the test limb. A digital metronome will be used to maintain the pace during the exercise.

Load: 12 repetition maximum; Nr. of repetition: 12; Nr. of sets: 3; Rest between sets: 120 seconds; Time under tension: 8 seconds; Distribution of load: Concentric (3 seconds), Eccentric (3 seconds), Isometric (2 seconds).

Other: Knee specific resistance exercise
Knee specific resistance exercise




Primary Outcome Measures :
  1. Change in Pain pressure threshold (PPT) at the center of patella. [ Time Frame: This will be assessed at 1) baseline, 2) approximately 5 minutes after the first exercise intervention (hip or knee) and 3) approximately 5 minutes after the second exercise intervention (hip or knee). ]
    The acute effect of hip versus knee exercises on PPT at the center of patella will be compared. These measures will be taken from the test limb. PPT is defined as the point where pressure becomes painful and will be assessed by handheld pressure algometry (SOMEDIC Electronics, Solna, Sweden). The pressure will be applied with at a rate of 30 kPa/s at a perpendicular angle, to a 1cm2 area on the skin surface. Subjects will be given a handheld switch and will be instructed to press it as soon as the stimulus changes from pressure to pain. PPT will be measured twice at each time-point and the average will be calculated and used for the analyses. A mark will be drawn on the center of patella to make sure the two measures are taken from the same site. There will be a 30-second break between each measurements.


Secondary Outcome Measures :
  1. Change in PPT at the muscle belly of the m. tibialis anterior. [ Time Frame: This will be assessed at 1) baseline, 2) within 20 minutes after completing the first exercise intervention (hip or knee) and 3) within 20 minutes after completing the second exercise intervention (hip or knee). ]
    The acute effect of hip versus knee exercises on PPT at the muscle belly of the m. tibialis anterior will be compared. These measures will be taken from the test limb. PPT is defined as the point where pressure becomes painful and will be assessed by handheld pressure algometry (SOMEDIC Electronics, Solna, Sweden). The pressure will be applied with at a rate of 30 kPa/s at a perpendicular angle, to a 1cm2 area on the skin surface. Subjects will be given a handheld switch and will be instructed to press it as soon as the stimulus changes from pressure to pain. PPT will be measured twice at each time-point and the average will be calculated and used for the analyses. A mark will be drawn on the muscle belly of the m. tibialis anterior to make sure the two measures are taken from the same site. There will be a 30-second break between each measurements.

  2. Change in PPT at the lateral epicondyle on the contralateral elbow. [ Time Frame: This will be assessed at 1) baseline, 2) within 20 minutes after completing the first exercise intervention (hip or knee) and 3) within 20 minutes after completing the second exercise intervention (hip or knee). ]
    The acute effect of hip versus knee exercises on PPT at the lateral epicondyle on the contralateral elbow will be compared. These measures will be taken from the contralateral elbow of the test limb. PPT is defined as the point where pressure becomes painful and will be assessed by handheld pressure algometry (SOMEDIC Electronics, Solna, Sweden). The pressure will be applied with at a rate of 30 kPa/s at a perpendicular angle, to a 1cm2 area on the skin surface. Subjects will be given a handheld switch and will be instructed to press it as soon as the stimulus changes from pressure to pain. PPT will be measured twice at each time-point and the average will be calculated and used for the analyses. A mark will be drawn on the lateral epicondyle on the contralateral elbow to make sure the two measures are taken from the same site. There will be a 30-second break between each measurements.

  3. Change in pain detection threshold (PDT) measured with cuff pressure allometry at the lower leg of both limbs. [ Time Frame: This will be assessed at 1) baseline, 2) within 20 minutes after completing the first exercise intervention (hip or knee) and 3) within 20 minutes after completing the second exercise intervention (hip or knee). ]
    The cuff will inflate with 1 kPa per second and the participants are instructed to start rating their pain on the electronic VAS as soon as the sensation of pressure becomes painful (pain detection threshold).

  4. Change in pain tolerance threshold (PTT) measured with cuff pressure allometry at the lower leg of both limbs. [ Time Frame: This will be assessed at 1) baseline, 2) within 20 minutes after completing the first exercise intervention (hip or knee) and 3) within 20 minutes after completing the second exercise intervention (hip or knee). ]
    The cuff will inflate with 1 kPa per second and the participants are instructed to start rating their pain on the electronic VAS as soon as the sensation of pressure becomes painful. Participants are instructed to press the release button when the pain becomes intolerable (pain tolerance threshold).

  5. Change in temporal summation of pain assessed by cuff pressure allometry at the lower leg of the test limb. [ Time Frame: This will be assessed at 1) baseline, 2) within 20 minutes after completing the first exercise intervention (hip or knee) and 3) within 20 minutes after completing the second exercise intervention (hip or knee). ]
    The cuff will apply 10 repetitive stimulus at 100% of the PTT measured by the cuff algometer on the test limb. Each stimulus has a duration of 1 second followed by 1 second where the cuff is deflated. The participant will be asked to rate the pain intensity on an electronic VAS continuously throughout the test. The cuff-system software will automatically identify the highest recorded VAS within each of the 1 second deflations.

  6. Change in condition pain modulation assessed by cuff pressure allometry at the lower leg of the test limb. [ Time Frame: This will be assessed at 1) baseline, 2) within 20 minutes after completing the first exercise intervention (hip or knee) and 3) within 20 minutes after completing the second exercise intervention (hip or knee). ]
    Data on PDT and PTT from the contralateral limb will be used to calibrate the cuff system before this test. The cuff on the contralateral limb will inflated to 70% of the PTT measured from the contralateral limb. Participants are instructed to ignore this pressure an to only focus on the test limb. As before, the cuff on the test limb will inflate with 1 kPa per second and the participants are instructed to start rating their pain on the electronic VAS scale as soon as the sensation of pressure becomes painful (PDT). Participants are instructed to press the release button when the pain becomes intolerable (PTT).

  7. Change in self-reported pain before and after each exercise set reported on a numeric pain rating scale (NPRS). [ Time Frame: This will be assessed during the first exercise intevention (hip or knee) and approximately 30 minutes after, during the second exercise intervention (hip or knee). ]
    Participants will be asked to rate their knee pain intensity right before and immediately after each of the three sets within each exercise. The mean difference between the before and after assessments will be calculated and analyzed.



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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with PFP are required to have current non-traumatic anterior or retropatellar knee pain which they have experienced ongoing or recurrently for a duration of at least 5 years.
  • At least two of the following daily activities should provoke knee-related symptoms: prolonged sitting or kneeling, squatting, running, hopping, or stair walking, tenderness on palpation of the patella or double leg squatting.
  • Worst pain during the previous week have to be of more than 3 cm on a 10-cm visual analog scale (VAS).

Exclusion Criteria:

  • Patients who have sustained a traumatic injury to the hip, knee, ankle or the lumbar spine within the past 3 month will be excluded.
  • Other identifiable knee conditions in isolation (that is, not occuring concurrently with PFP. As an example, if the subject has isolated patellar tendinopathy they will be excluded. If the subject has PFP and concurrent pain at the patellar tendon, they will be included).
  • Individuals with rheumatoid arthritis, knee joint effusion, self-reported patellofemoral instability, known malign conditions, neurological disease or previously knee surgery will be excluded as well.
  • In cases with suspicion of serious pathology a rheumatologist will be consulted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054701


Locations
Denmark
Research Unit For General Practice in Aalborg
Aalborg, Denmark
Sponsors and Collaborators
Aalborg University
Investigators
Study Director: Michael S Rathleff, PhD Aalborg University

Responsible Party: Michael Skovdal Rathleff, Associate Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT03054701     History of Changes
Other Study ID Numbers: N-20160058
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data will be available on request after manuscript has been published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Skovdal Rathleff, Aalborg University:
Patellofemoral pain
PFP
PFPS

Additional relevant MeSH terms:
Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases