Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study

Patellofemoral Osteoarthritis Clinical Trial

Official title:

The Effect of Hip and Core Muscle Strengthening on Pain, Function, Quality of Life and Movement Patterns in Persons With Patellofemoral Osteoarthritis: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825238
• Other study ID #: 297090
• Status: Completed
• Phase: N/A
• Start date: October 23, 2012
• Est. completion date: December 11, 2015

Study information

• Verified date: May 2018
• Source: University of the Sciences in Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to develop and test the feasibility of an exercise intervention for persons with painful knee osteoarthritis involving the patella (kneecap). Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week supervised exercise program that targets strengthening the hip and trunk core muscles. Painfree control participants will attend one session to gather biomechanical, strength, and function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility outcomes include adherence to the treatment program, recruitment, and retention. It is hypothesized that PFOA group participants will change score on a knee pain and function questionnaire by the minimum clinically important difference score for positive improvement at the end of the 6-week intervention program.

Description:

The investigators propose to develop and test the feasibility of a 6-week supervised hip and core muscle exercise intervention for persons with painful patellofemoral osteoarthritis (PFOA), a common condition for middle-aged and older adults. Currently there is limited evidence regarding effective conservative interventions for PFOA, a chronic condition that is painful and limits function and quality of life. Exercise is recommended as a first-line treatment for knee osteoarthritis, but the optimal type of exercise for PFOA is unknown. This intervention is based upon similar programs shown to improve pain and function in younger persons with patellofemoral pain, a condition that may lead to PFOA. Feasibility outcomes include adherence to the treatment program, recruitment, retention, and the impact of the intervention on participants' pain and function at 6-weeks and 6 months after finishing the program. The investigators will also compare PFOA participants to a matched pain-free volunteer control group to explore the differences in their biomechanics, muscle strength, pain report, and function at baseline. Data from this feasibility study will be used to design a future randomized controlled trial investigating the efficacy of conservative exercise interventions for PFOA. The investigators' overarching goal is to develop a conservative exercise intervention that improves the symptoms, function, and quality of life of persons with PFOA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 11, 2015
• Est. primary completion date: December 11, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

Patellofemoral Osteoarthritis group: 1) age 35-70 years, 2) have been diagnosed with knee osteoarthritis in one or both knees with symptoms primarily in the anterior knee, 3) radiographic evidence of = Grade 1 osteophytes or joint space narrowing at the patellofemoral joint according to the Osteoarthritis Research Society International (OARSI) grading scale (0 = none, 1 = mild/possible, 2 = moderate/definite, 3 = severe), 4) pain produced by = 2 of the following: descending steps, ascending steps, sit-to-stand, squatting, kneeling, prolonged knee flexion, increased activity (e.g., hiking), morning stiffness < 30 minutes, stiffness after sitting = 30 minutes, history of patellar subluxation or dislocation in the past.

Control group: 1) age 35-70 years, 2) no known diagnosis by a physician of knee osteoarthritis, 3) pain free in the lower extremities at the time of enrollment into the study and for 1 week prior to enrollment.

Exclusion Criteria:

Patellofemoral Osteoarthritis (PFOA) group: 1) the presence of other conditions that may cause knee pain (e.g., patellar tendonitis, rheumatoid arthritis), 2) neurologic or musculoskeletal conditions that may alter lower extremity kinematics (e.g., multiple sclerosis, hip arthritis/arthroplasty), 3) history of a fracture of the knee, 4) pregnancy, 5) knee injections within the past 3 months, 6) inability to understand English.

Control group: 1) all previously listed exclusion criteria for the PFOA group, 2) knee pain produced by 2 or more of the following: descending steps, ascending steps, sit-to-stand, squatting, kneeling, prolonged knee flexion, or a history of patellar subluxation or dislocation in the past.

Related Conditions & MeSH terms

• Osteoarthritis
• Patellofemoral Osteoarthritis

Intervention

Other:
• Supervised exercise program

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of the Sciences	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of the Sciences in Philadelphia	Thomas Jefferson University, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hoglund LT, Pontiggia L, Kelly JD 4th. A 6-week hip muscle strengthening and lumbopelvic-hip core stabilization program to improve pain, function, and quality of life in persons with patellofemoral osteoarthritis: a feasibility pilot study. Pilot Feasibil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in peak isometric muscle torque: hip abductors, hip extensors, hip external rotators, and knee extensors		6 weeks
Other	Change in hip and knee joint biomechanics during step-down and sit-to-stand tasks		6 weeks
Other	Change in KOOS symptoms subscale		6 weeks
Other	Change in KOOS sport/recreation subscale		6 weeks
Other	Change in KOOS quality of life subscale		6 weeks
Other	Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of lower extremity biomechanics (joint angles)	Lower extremity peak joint angles will be measured with a motion capture system during functional activities.	6 weeks
Other	Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of lower extremity muscle torque	Lower extremity peak isometric torque will be measured with a dynamometer (force gauge).	6 weeks
Other	Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of physical performance on the Timed-Up-and Go test	Time to perform the Timed-Up-and-Go test of walking ability will be measured with a stop watch.	6 weeks
Other	Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of symptoms on the Knee Injury and Osteoarthritis Score (KOOS) questionnaire	Responses to the KOOS questionnaire will be gathered and the score calculated.	6 weeks
Primary	Feasibility (adherence)	Adherence to supervised program (= 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.	6 weeks
Primary	Feasibility (retention rates)	Completion of baseline and 6-week evaluation sessions. Percentage completion for both data collection sessions.	6 weeks
Primary	Feasibility (follow-up response): questionnaire	Response to 6-month follow-up - return Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (= 80% complete and return KOOS): Percentage completion and return for KOOS.	6 months
Primary	Feasibility (recruitment rates)	Total number enrolled and total number screened out.	4 years
Primary	Feasibility (establish viability of underlying treatment model): global rating of change	Response to participation in intervention program in terms of overall rating of change (= 80% will achieve Global Rating of Change score = 3 [scale -5 to 5] - positive numbers indicate positive change).	6 weeks
Primary	Feasibility (follow-up response): exercise diary	Response to 6-month follow-up - return exercise diary (= 80% complete and return exercise diary): Percentage completion and return for diary.	6 months
Primary	Feasibility (establish viability of underlying treatment model): pain rating	Response to participation in intervention program in terms of pain rating (= 80% will change score on KOOS pain subscale by the minimum clinically important difference score for positive improvement [positive change of 10 points] - at the end of the 6-week intervention program).	6 weeks
Primary	Feasibility (establish viability of underlying treatment model): activity of daily living rating	Response to participation in intervention program in terms of activity of daily living rating (= 80% will change score on KOOS activity of daily living (ADL) subscale by the minimum clinically important difference score for positive improvement [positive change of 10 points] - at the end of the 6-week intervention program).	6 weeks
Secondary	Establish impact of intervention on physical performance	Change in score on Timed-Up-and-Go test.	6 weeks
Secondary	Determine long-term benefits of intervention: pain rating	Change in score of KOOS pain subscale score for positive improvement: 6-month follow-up KOOS versus baseline KOOS scores (more positive scores equals lower pain level)	6 months
Secondary	Determine long-term benefits of intervention: activity of daily living rating	Change in score of KOOS ADL subscale score for positive improvement: 6-month follow-up KOOS versus baseline KOOS scores (more positive scores equals better function in activities of daily living)	6 months

External Links

•   A 6-week hip muscle strengthening and lumbopelvic-hip core stabilization program to improve pain, function, and quality of life in persons with patellofemoral osteoarthritis: a feasibility pilot study.