Trial Outcomes & Findings for Effectiveness Trial for Evaluating IAHA for PFPS (NCT NCT01811654)
NCT ID: NCT01811654
Last Updated: 2020-02-26
Results Overview
A 100mm visual analog scale (VAS) for activity related pain assessment will serve as the primary outcome measure. The 2-sample t-test comparing the two treatment groups' mean change from baseline issued. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The 2 sample t-test approximates the test of the null hypothesis that there is a difference in mean change from baseline in the VAS for activity-related pain between the HA group and control group. Higher scores indicate higher level of pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
At baseline and 3 month follow-up
Results posted on
2020-02-26
Participant Flow
Participant milestones
| Measure |
Standard Care
Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
|
Intra-Articular Hyaluronic Acid-Euflexxa
Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.
Intra-Articular Hyaluronic Acid-Euflexxa: IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness Trial for Evaluating IAHA for PFPS
Baseline characteristics by cohort
| Measure |
Intra-Articular Hyaluronic Acid-Euflexxa
n=16 Participants
Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.
|
Standard Care
n=14 Participants
Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and 3 month follow-upPopulation: Both " Overall Number of Participants Analyzed" and "Participant Flow" are now consistent
A 100mm visual analog scale (VAS) for activity related pain assessment will serve as the primary outcome measure. The 2-sample t-test comparing the two treatment groups' mean change from baseline issued. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The 2 sample t-test approximates the test of the null hypothesis that there is a difference in mean change from baseline in the VAS for activity-related pain between the HA group and control group. Higher scores indicate higher level of pain.
Outcome measures
| Measure |
Standard Care
n=14 Participants
Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
|
Intra-Articular Hyaluronic Acid-Euflexxa
n=16 Participants
Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.
Intra-Articular Hyaluronic Acid-Euflexxa: IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score
Baseline
|
70 millimeters
Standard Deviation 13.59
|
62.23 millimeters
Standard Deviation 15.48
|
|
Change in Visual Analog Scale (VAS) Score
3 Months
|
37.61 millimeters
Standard Deviation 31.40
|
25.025 millimeters
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 3 month follow-upEncompasses 10 statements regarding PFPS pain. Severity scale consists of 10 statements, rated from "0" indicating "no pain" and a "10" indicating "pain as bad as it could be."
Outcome measures
| Measure |
Standard Care
n=14 Participants
Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented.
|
Intra-Articular Hyaluronic Acid-Euflexxa
n=16 Participants
Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms.
Intra-Articular Hyaluronic Acid-Euflexxa: IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.
|
|---|---|---|
|
PFPS Severity Scale (PSS) Score
Climbing stairs
|
5 score on a scale
Standard Deviation 2.44
|
5.21 score on a scale
Standard Deviation 2.32
|
|
PFPS Severity Scale (PSS) Score
squatting
|
5.5 score on a scale
Standard Deviation 3.46
|
4.42 score on a scale
Standard Deviation 3.77
|
|
PFPS Severity Scale (PSS) Score
walking
|
3.5 score on a scale
Standard Deviation 2.22
|
3.64 score on a scale
Standard Deviation 2.37
|
|
PFPS Severity Scale (PSS) Score
Jogging
|
3.87 score on a scale
Standard Deviation 4.08
|
3.42 score on a scale
Standard Deviation 3.56
|
|
PFPS Severity Scale (PSS) Score
Running
|
3.75 score on a scale
Standard Deviation 4.37
|
4.07 score on a scale
Standard Deviation 4.08
|
|
PFPS Severity Scale (PSS) Score
sport
|
2.06 score on a scale
Standard Deviation 3.76
|
3.64 score on a scale
Standard Deviation 3.95
|
|
PFPS Severity Scale (PSS) Score
sitting with bent
|
5.81 score on a scale
Standard Deviation 2.71
|
4.35 score on a scale
Standard Deviation 2.92
|
|
PFPS Severity Scale (PSS) Score
kneeling
|
4.56 score on a scale
Standard Deviation 3.66
|
5.21 score on a scale
Standard Deviation 2.51
|
|
PFPS Severity Scale (PSS) Score
pain at rest
|
4.06 score on a scale
Standard Deviation 2.54
|
2.57 score on a scale
Standard Deviation 2.10
|
|
PFPS Severity Scale (PSS) Score
following activities
|
4.75 score on a scale
Standard Deviation 3.06
|
4.42 score on a scale
Standard Deviation 2.62
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intra-Articular Hyaluronic Acid-Euflexxa
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place