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Hip Strengthening Versus Quadriceps Based Training for Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Isolated hip strengthening
Quadriceps based training
Active control
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Patellofemoral pain syndrome, Anterior knee pain, Randomised controlled trial, Exercise intervention, Hip strengthening, Quadriceps based training, Anterior knee pain score

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sorlandet hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Isolated hip strengthening

Quadriceps based training

Active control

Arm Description

Isolated hip strengthening (abduction, external rotation, extension)

Quadriceps based training (mini-squat, straight leg raising, terminal extensions)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analog Scale (VAS)
Visual Analog Scale (VAS) for pain (0-10cm)
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).
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.
Hip abduction, external rotation and knee extension strength
Isometric strength will be measured for hip abduction, hip external rotation and knee extension.
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.
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
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.
HSCL-10
The Hopkins Symptom Checklist (HSCL) is a symptom inventory which measures symptoms of anxiety and depression.
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.
Pain drawing with number of painful regions
An adaptation of the Standardised Nordic Questionnaire will be used to register the number of painful areas.

Full Information

First Posted
February 14, 2014
Last Updated
November 9, 2022
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT02114294
Brief Title
Hip Strengthening Versus Quadriceps Based Training for Patellofemoral Pain Syndrome
Official Title
Does Isolated Hip Strengthening for Patellofemoral Pain Syndrome Give Better Long Term Results Than Traditional Quadriceps Based Training? A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Patellofemoral pain syndrome, Anterior knee pain, Randomised controlled trial, Exercise intervention, Hip strengthening, Quadriceps based training, Anterior knee pain score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isolated hip strengthening
Arm Type
Experimental
Arm Description
Isolated hip strengthening (abduction, external rotation, extension)
Arm Title
Quadriceps based training
Arm Type
Active Comparator
Arm Description
Quadriceps based training (mini-squat, straight leg raising, terminal extensions)
Arm Title
Active control
Arm Type
Other
Arm Description
Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime. They are encouraged to remain active.
Intervention Type
Other
Intervention Name(s)
Isolated hip strengthening
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quadriceps based training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active control
Intervention Description
Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime. They are encouraged to remain active.
Primary Outcome Measure Information:
Title
Anterior knee pain score
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Visual Analog Scale (VAS) for pain (0-10cm)
Time Frame
3 months
Title
Global Score Global Score
Description
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).
Time Frame
3 months
Title
Step-down test
Description
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.
Time Frame
3 months
Title
Hip abduction, external rotation and knee extension strength
Description
Isometric strength will be measured for hip abduction, hip external rotation and knee extension.
Time Frame
3 months
Title
Hip abduction endurance
Description
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.
Time Frame
3 months
Title
EQ 5D 5L
Description
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
Time Frame
3 months
Title
Tampa scale for kinesiophobia
Description
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.
Time Frame
3 months
Title
HSCL-10
Description
The Hopkins Symptom Checklist (HSCL) is a symptom inventory which measures symptoms of anxiety and depression.
Time Frame
3 months
Title
Knee self-efficacy score (K-SES)
Description
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.
Time Frame
3 months
Title
Pain drawing with number of painful regions
Description
An adaptation of the Standardised Nordic Questionnaire will be used to register the number of painful areas.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigurd Liavaag, MD, PhD
Organizational Affiliation
Sørlandet sykehus HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexandra C Hott, MD
Organizational Affiliation
Sørlandet sykehus HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet hospital
City
Kristiansand
State/Province
Vest Agder
ZIP/Postal Code
4633
Country
Norway

12. IPD Sharing Statement

Citations:
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Hip Strengthening Versus Quadriceps Based Training for Patellofemoral Pain Syndrome

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