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Patellofemoral Pain SyndromeNCT02114294

Hip Strengthening Versus Quadriceps Based Training for Patellofemoral Pain Syndrome

A study testing Isolated hip strengthening and Quadriceps based training in people with Patellofemoral Pain Syndrome, run by Sorlandet Hospital HF at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 40 years
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
Isolated hip strengthening and Quadriceps based training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteNorway
Study dates
Sep 2014to Dec 2023
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 16 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Sorlandet hospital

    Kristiansand, Vest Agder, 4633

Other trials in Norway

About this study

Official title: 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.

Being tested
Isolated hip strengthening, Quadriceps based training, Active control
Keywords
Patellofemoral pain syndrome, Anterior knee pain, Randomised controlled trial, Exercise intervention, Hip strengthening, Quadriceps based training, Anterior knee pain score
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isolated hip strengtheningOther

    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.

  • Quadriceps based trainingOther

    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.

  • Active controlOther

    Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime. They are encouraged to remain active.

Study groups in NCT02114294
Study groupRoleWhat they receive
Isolated hip strengtheningExperimentalIsolated hip strengthening (abduction, external rotation, extension)
Receives: Other: Isolated hip strengthening
Quadriceps based trainingActive comparatorQuadriceps based training (mini-squat, straight leg raising, terminal extensions)
Receives: Other: Quadriceps based training
Active controlOtherPatients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime. They are encouraged to remain active.
Receives: Other: Active control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anterior knee pain score

    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.

    Measured: 3 months

Secondary outcomes (10)
  1. Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) for pain (0-10cm)

    Measured: 3 months

  2. Global Score Global Score

    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).

    Measured: 3 months

  3. Step-down test

    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.

    Measured: 3 months

  4. Hip abduction, external rotation and knee extension strength

    Isometric strength will be measured for hip abduction, hip external rotation and knee extension.

    Measured: 3 months

  5. Hip abduction endurance

    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.

    Measured: 3 months

  6. EQ 5D 5L

    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

    Measured: 3 months

  7. Tampa scale for kinesiophobia

    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.

    Measured: 3 months

  8. HSCL-10

    The Hopkins Symptom Checklist (HSCL) is a symptom inventory which measures symptoms of anxiety and depression.

    Measured: 3 months

  9. Knee self-efficacy score (K-SES)

    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.

    Measured: 3 months

  10. Pain drawing with number of painful regions

    An adaptation of the Standardised Nordic Questionnaire will be used to register the number of painful areas.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2019
  4. Study completionDec 2023 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02114294
Sponsor's protocol ID
2013/1860REK
Status last verified
Mar 2022
First submitted
14 Feb 2014
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15703965
  • 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.

    PubMed 15262632
  • 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.

    PubMed 20436239
  • 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.

    PubMed 22027216
  • 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.

    PubMed 21654093
  • 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.

    PubMed 22951491
  • 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.

    PubMed 19052244
  • 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.

    PubMed 19226237
  • 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.

    PubMed 8461073
  • 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.

    PubMed 35284585
  • 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.

    PubMed 31821014
  • 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.

    PubMed 31583918
  • 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.

    PubMed 30958707
  • 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.

    PubMed 25879452

Questions about this trial

What is this clinical trial studying?

A study testing Isolated hip strengthening and Quadriceps based training in people with Patellofemoral Pain Syndrome, run by Sorlandet Hospital HF at 1 site in Norway.

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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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 Norway. 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?

Results are not available in the source record.

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?

Anterior knee pain score (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02114294, which also lists 14 linked publications.

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 10 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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