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

NCT03054701 | Completed DMC

• 1 other identifier: N-20160058
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Patellofemoral pain; PFP; PFPS

Outcome Measures

Primary Outcomes (1)

• Change in Pain pressure threshold (PPT) at the center of patella.

  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.

  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).

Secondary Outcomes (7)

• Change in PPT at the muscle belly of the m. tibialis anterior.

  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).

• Change in PPT at the lateral epicondyle on the contralateral elbow.

  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).

• Change in pain detection threshold (PDT) measured with cuff pressure allometry at the lower leg of both limbs.

  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).

• Change in pain tolerance threshold (PTT) measured with cuff pressure allometry at the lower leg of both limbs.

  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).

• Change in temporal summation of pain assessed by cuff pressure allometry at the lower leg of the test limb.

  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).

Study Arms (2)

Sidelying hip abduction exercise

EXPERIMENTAL

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

Sitting knee extension exercise

ACTIVE COMPARATOR

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

Interventions

Hip specific resistance exercise OTHER

Hip specific resistance exercise

Sidelying hip abduction exercise

Knee specific resistance exercise OTHER

Knee specific resistance exercise

Sitting knee extension exercise

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Research Unit For General Practice in Aalborg

Aalborg, Denmark

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Michael S Rathleff, PhD

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the order of the exercises and the participants will be blinded to the study-hypothesis.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 16, 2017
• Study Start: March 7, 2017
• Primary Completion: May 17, 2017
• Study Completion: June 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)