- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02114294
Hip Strengthening Versus Quadriceps Based Training for Patellofemoral Pain Syndrome
November 9, 2022 updated by: Sorlandet Hospital HF
Does Isolated Hip Strengthening for Patellofemoral Pain Syndrome Give Better Long Term Results Than Traditional Quadriceps Based Training? A Randomised Controlled Trial.
This is a Randomized Controlled Trial (RCT) regarding conservative treatment of Patellofemoral Pain Syndrome (PFPS).
Patellofemoral Pain Syndrome (PFPS) is a very common cause of knee pain in young active adults with a high rate of recurrent and/or chronic occurrence.
PFPS is notoriously difficult to treat and has been referred to as "one of the most vexatious clinical challenges in rehabilitative medicine".
Its etiology is unclear but is commonly thought to be related to pathomechanics in the patellofemoral joint (PFJ).
There are many factors that can influence PFJ mechanics.
Among these, quadriceps strength and timing has been shown to be important.
As such, treatment of PFPS has traditionally been based on correction of pathomechanics through influencing quadriceps strength and timing.
However, a growing body of evidence is revealing the importance of strength and control of hip abduction and external rotation in PFPS.
Hip strength in ab/adduction and rotation is thought to influence femoral positioning in the patellofemoral joint, thereby affecting PFJ mechanics.
Several cohort and smaller RCT studies within the last 7 years have shown that additional exercises for hip strength and control give an improved effect in pain and function compared with quadriceps based training alone.
A smaller RCT from 2012 compared isolated hip strengthening exercises to a control group and found surprisingly good results on pain in function in the hip strengthening group.
The investigators plan a RCT in which isolated hip strengthening will be compared to traditional quadriceps training and a control group which will receive no structured training.
Primary outcomes will be pain and function.
This high-quality study will include 40-50 patients in each group, making it one of the largest of its kind on conservative treatment for PFPS.
In contrast to the vast majority of studies of this type, this study will also include men, which will potentially help to fill a significant gap in the literature on this subject.
The investigators study will therefore be an important contribution to elucidating the etiology of PFPS and improving treatment options for both men and women in the future.
As well, the role of psychometric parameters will be examined and a standardized clinical test for hip abduction endurance will be developed.
Follow-up at 3 months and 12 months is completed and published.
A 5-year follow-up of the same patients is underway.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Vest Agder
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Kristiansand, Vest Agder, Norway, 4633
- Sorlandet hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 16-40 years
- Insidious onset of symptoms not related to trauma
- Symptoms more than 3 months
- A minimum of VAS 3 on VAS-W
- Peri- or retropatellar pain during or after at least two of the following: Stair ascent or descent, hopping, running, prolonged sitting, squatting, kneeling.
- Pain on one of the following: Compression of the patella, palpation of the patellar facets
Exclusion Criteria:
- Clinical findings indicative of meniscal or other intraarticular injury
- Clinical findings indicative of injury to or increased laxity of cruciate or collateral ligaments
- Findings on MRI indicative of other intraarticular pathology.
- Clinical and/or x-ray findings (plain anterior-posterior, lateral and skyline view) indicative of osteoarthritis, Osgood-Schlatter or Sinding-Larsen-Johanssen syndrome
- Clinical findings indicative of knee joint effusion
- Significant pain from hip or lumbar spine on clinical evaluation, with potential for causing referred pain to the knee or hindering the patient's ability to perform the prescribed exercises.
- Recurrent patellar subluxation or dislocation.
- Previous surgery to the knee joint
- NSAID or cortisone use over an extended period of time
- Having suffered trauma to the knee joint judged during clinical evaluation to have a significant effect on the presenting clinical condition.
- Physiotherapy or other similar treatment for patellofemoral pain syndrome within the previous 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isolated hip strengthening
Isolated hip strengthening (abduction, external rotation, extension)
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Exercise program that is carried out by subjects under supervision once a week and then performed at home 2 additional times without supervision for a total of 6 weeks.
Hip strengthening group will train hip abduction, hip external rotation and hip extension.
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Active Comparator: Quadriceps based training
Quadriceps based training (mini-squat, straight leg raising, terminal extensions)
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Exercise program that is carried out by subjects under supervision once a week and then performed at home 2 additional times without supervision for a total of 6 weeks.
Quadriceps group will train mini-squat, straight leg raising, terminal extensions.
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Other: Active control
Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime.
They are encouraged to remain active.
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Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime.
They are encouraged to remain active.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anterior knee pain score
Time Frame: 3 months
|
Anterior Knee Pain Score (AKPS) is a measurement of subjective symptoms and functional limitations in patellofemoral pain, and has been validated for use in this patient population.
The AKPS consists of a 13-point questionnaire with categories related to different levels of function in the knee.
The categories within each question are weighted, and the responses are summed for an overall index where 100 represents perfect function.
The mean clinically important difference (MCID) has been determined to be 10 points.
This questionnaire will be translated to Norwegian and validated according to standard scientific procedures with approval from Kuala et al.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 3 months
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Visual Analog Scale (VAS) for pain (0-10cm)
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3 months
|
Global Score Global Score
Time Frame: 3 months
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An 18-point likert scale for measuring patients' global assessment of change compared with baseline will be carried out at 3 and 12 months.
The scale ranges from -9 (maximum deterioration) to +9 (maximum improvement).
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3 months
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Step-down test
Time Frame: 3 months
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The step down as performed according to standardised instruction will be used to quantify changes in patients' function.
The measure is number of repetitions in 30 seconds.
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3 months
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Hip abduction, external rotation and knee extension strength
Time Frame: 3 months
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Isometric strength will be measured for hip abduction, hip external rotation and knee extension.
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3 months
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Hip abduction endurance
Time Frame: 3 months
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Testing is carried out in side-lying position with a 5kg weight around the ankle of the upper leg, which is abducted to 30 degrees above the horizontal plane.
Time successfully held in target area is measured in seconds.
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3 months
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EQ 5D 5L
Time Frame: 3 months
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EQ-5D-5L is calculated on the basis of five questions about daily activities, pain and psychological status with five possible answers for each question.
In addition the subject scores his/her overall health on a 1-100 scale.
The results are translated to a single summary index value through the use of a table
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3 months
|
Tampa scale for kinesiophobia
Time Frame: 3 months
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The Tampa scale for kinesiophobia (TSK) is a 13 -item questionnaire aimed at the assessment of fear of movement/re-injury.
Each item is scored on a 4-point Likert scale with alternatives ranging from "strongly disagree" (0) to "strongly agree".
This gives a possible total score range from 0 to 52.
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3 months
|
HSCL-10
Time Frame: 3 months
|
The Hopkins Symptom Checklist (HSCL) is a symptom inventory which measures symptoms of anxiety and depression.
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3 months
|
Knee self-efficacy score (K-SES)
Time Frame: 3 months
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K-SES is a self-administered instrument consisting of in total four sections in which patients score how certain they are about specific activities currently and in the future.
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3 months
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Pain drawing with number of painful regions
Time Frame: 3 months
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An adaptation of the Standardised Nordic Questionnaire will be used to register the number of painful areas.
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sigurd Liavaag, MD, PhD, Sørlandet Sykehus HF
- Principal Investigator: Alexandra C Hott, MD, Sørlandet Sykehus HF
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nakagawa TH, Muniz TB, Baldon Rde M, Dias Maciel C, de Menezes Reiff RB, Serrao FV. The effect of additional strengthening of hip abductor and lateral rotator muscles in patellofemoral pain syndrome: a randomized controlled pilot study. Clin Rehabil. 2008 Dec;22(12):1051-60. doi: 10.1177/0269215508095357.
- Fukuda TY, Melo WP, Zaffalon BM, Rossetto FM, Magalhaes E, Bryk FF, Martin RL. Hip posterolateral musculature strengthening in sedentary women with patellofemoral pain syndrome: a randomized controlled clinical trial with 1-year follow-up. J Orthop Sports Phys Ther. 2012 Oct;42(10):823-30. doi: 10.2519/jospt.2012.4184. Epub 2012 Aug 2.
- Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
- Prins MR, van der Wurff P. Females with patellofemoral pain syndrome have weak hip muscles: a systematic review. Aust J Physiother. 2009;55(1):9-15. doi: 10.1016/s0004-9514(09)70055-8.
- Witvrouw E, Werner S, Mikkelsen C, Van Tiggelen D, Vanden Berghe L, Cerulli G. Clinical classification of patellofemoral pain syndrome: guidelines for non-operative treatment. Knee Surg Sports Traumatol Arthrosc. 2005 Mar;13(2):122-30. doi: 10.1007/s00167-004-0577-6. Epub 2005 Feb 10.
- Witvrouw E, Danneels L, Van Tiggelen D, Willems TM, Cambier D. Open versus closed kinetic chain exercises in patellofemoral pain: a 5-year prospective randomized study. Am J Sports Med. 2004 Jul-Aug;32(5):1122-30. doi: 10.1177/0363546503262187. Epub 2004 May 18.
- Souza RB, Draper CE, Fredericson M, Powers CM. Femur rotation and patellofemoral joint kinematics: a weight-bearing magnetic resonance imaging analysis. J Orthop Sports Phys Ther. 2010 May;40(5):277-85. doi: 10.2519/jospt.2010.3215.
- Dolak KL, Silkman C, Medina McKeon J, Hosey RG, Lattermann C, Uhl TL. Hip strengthening prior to functional exercises reduces pain sooner than quadriceps strengthening in females with patellofemoral pain syndrome: a randomized clinical trial. J Orthop Sports Phys Ther. 2011 Aug;41(8):560-70. doi: 10.2519/jospt.2011.3499. Epub 2011 Jun 7. Erratum In: J Orthop Sports Phys Ther. 2011 Sep;41(9):700.
- Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.
- Hott A, Pripp AH, Juel NG, Liavaag S, Brox JI. Self-efficacy and Emotional Distress in a Cohort With Patellofemoral Pain. Orthop J Sports Med. 2022 Mar 8;10(3):23259671221079672. doi: 10.1177/23259671221079672. eCollection 2022 Mar.
- Hott A, Brox JI, Pripp AH, Juel NG, Liavaag S. Predictors of Pain, Function, and Change in Patellofemoral Pain. Am J Sports Med. 2020 Feb;48(2):351-358. doi: 10.1177/0363546519889623. Epub 2019 Dec 10.
- Hott A, Liavaag S, Juel NG, Brox JI, Ekeberg OM. The reliability, validity, interpretability, and responsiveness of the Norwegian version of the Anterior Knee Pain Scale in patellofemoral pain. Disabil Rehabil. 2021 Jun;43(11):1605-1614. doi: 10.1080/09638288.2019.1671499. Epub 2019 Oct 4.
- Hott A, Brox JI, Pripp AH, Juel NG, Paulsen G, Liavaag S. Effectiveness of Isolated Hip Exercise, Knee Exercise, or Free Physical Activity for Patellofemoral Pain: A Randomized Controlled Trial. Am J Sports Med. 2019 May;47(6):1312-1322. doi: 10.1177/0363546519830644. Epub 2019 Apr 8.
- Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
January 1, 2019
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
February 14, 2014
First Submitted That Met QC Criteria
April 14, 2014
First Posted (Estimate)
April 15, 2014
Study Record Updates
Last Update Posted (Actual)
November 10, 2022
Last Update Submitted That Met QC Criteria
November 9, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/1860REK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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