Trial Outcomes & Findings for Knee Bracing for People With Patellofemoral Osteoarthritis (NCT NCT00381563)

Results Overview

The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-06-29

Participant Flow

Subjects will be recruited through: public media including the Boston Metro, Community News, Baystate Banner and Tab, Craigslist; patients referred from BMC rheumatology, primary care, physical therapy, and orthopedics \& from Baptist Hospital orthopedic clinics, and persons already recruited from studies whose consent forms allow contact

Participant milestones

Participant milestones
Measure	Intervention to Placebo Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.	Placebo to Intervention Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
Overall Study STARTED	41	39
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention to Placebo Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.	Placebo to Intervention Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.
Overall Study Withdrawal by Subject	5	5
Overall Study Lost to Follow-up	2	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Knee Bracing for People With Patellofemoral Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention to Placebo n=41 Participants Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.	Placebo to Intervention n=39 Participants Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=93 Participants	26 Participants n=4 Participants	53 Participants n=27 Participants
Age, Categorical >=65 years	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Age, Continuous	60 years STANDARD_DEVIATION 9.7 • n=93 Participants	61 years STANDARD_DEVIATION 9.1 • n=4 Participants	60.6 years STANDARD_DEVIATION 9.3 • n=27 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	31 Participants n=4 Participants	63 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment United States	41 participants n=93 Participants	39 participants n=4 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the "intervention brace" group.

The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100

Outcome measures

Outcome measures
Measure	Intervention Brace n=67 Participants All participants who completed the trial (n=67) are re-grouped into the "intervention brace" group.
Change in Pain on the VIsual Analog Scale (VAS)	-.068 change in units on a scale from baseline Interval -6.2 to 4.8

PRIMARY outcome

Timeframe: 6 weeks

Population: In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the "intervention brace" group.

The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.

Outcome measures

Outcome measures
Measure	Intervention Brace n=67 Participants All participants who completed the trial (n=67) are re-grouped into the "intervention brace" group.
Change in WOMAC Pain Scale	-0.11 units on a scale change from baseline Interval -0.66 to 0.88

SECONDARY outcome

Timeframe: 6 weeks

Population: In this cross-over design where in one arm participants received the neutral brace with a realigning strap for the first 6 weeks then the neutral brace without a realigning strap for the second 6 weeks and the other arm used them in the opposite order, all 67 participants who completed the trial are re-grouped into the "intervention brace" group.

The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions. Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.

Outcome measures

Outcome measures
Measure	Intervention Brace n=67 Participants All participants who completed the trial (n=67) are re-grouped into the "intervention brace" group.
Change in WOMAC Function Scale	-0.02 units on a scale change from baseline Interval -2.83 to 2.79

Adverse Events

Intervention to Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo to Intervention

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

Director of Clinical Trials

New England Baptist Hospital

Phone: (617)754-6602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place