Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02825238
Other study ID # 297090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06060730 - Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
Recruiting NCT04937998 - PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT N/A
Completed NCT03281837 - 2 Weekly Intra-articular Hyaluronan Knee Injections, Given 1 wk. Apart, of HYMOVIS Combined With Physical Exercise Program (PEP) Compared to PEP Alone, in Relatively Young, Active Population of Subjects With Patellofemoral Osteoarthritis (PFOA) and/or Tibiofemoral Osteoarthritis (TFOA) N/A
Completed NCT05184439 - Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
Not yet recruiting NCT04332900 - Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis N/A
Completed NCT02610192 - nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis N/A
Recruiting NCT06163573 - Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage. Phase 2
Completed NCT04589871 - Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis N/A
Active, not recruiting NCT04817969 - Persona Ti-Nidium Post-Market Clinical Follow-up N/A
Active, not recruiting NCT04772625 - Failure Analysis of Patellofemoral Arthroplasty
Terminated NCT00816647 - A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction N/A