Trial Outcomes & Findings for Group Physical Therapy for Knee Osteoarthritis (NCT NCT00642772)

NCT ID: NCT00642772

Last Updated: 2015-04-28

Results Overview

Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline and Following 12-Week Intervention
• Results posted on: 2015-04-28

Participant Flow

Participant milestones

Measure	Group Physical Therapy Group Physical Therapy Intervention Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Overall Study STARTED	24
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure	Group Physical Therapy Group Physical Therapy Intervention Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	7

Baseline Characteristics

Group Physical Therapy for Knee Osteoarthritis

Baseline characteristics by cohort

Measure	Group Physical Therapy n=24 Participants Group Physical Therapy Intervention Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Age, Continuous	62 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Following 12-Week Intervention

Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.

Outcome measures

Measure	Group Physical Therapy n=14 Participants Group Physical Therapy Intervention Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 12-Week Score	34.1 units on a scale Standard Deviation 16.0
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Baseline Score	43.3 units on a scale Standard Deviation 14.6

Adverse Events

Group Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kelli Allen

Center for Health Services Research in Primary Care, Durham VA Medical Center

Phone: 919-286-0411

Email: kelli.allen@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place