Trial Outcomes & Findings for The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis (NCT NCT02634814)
NCT ID: NCT02634814
Last Updated: 2019-03-06
Results Overview
The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations.
COMPLETED
NA
90 participants
8-weeks from Baseline
2019-03-06
Participant Flow
Participant milestones
| Measure |
TENS and Therapeutic Exercise
Patients assigned to this group will receive a Select System TENS (i.e., transcutaneous electrical nerve stimulation TENS) unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of traditional therapeutic exercise (TE) will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
29
|
|
Overall Study
COMPLETED
|
30
|
23
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
TENS and Therapeutic Exercise
n=32 Participants
Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
n=29 Participants
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
n=29 Participants
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Total
n=90 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8-weeks from BaselinePopulation: A proportion of the participants were lost to follow-up.
The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations.
Outcome measures
| Measure |
TENS and Therapeutic Exercise
n=30 Participants
Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
n=23 Participants
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
n=29 Participants
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
|---|---|---|---|
|
Mean in Self-reported Disability Score as Measured by the Western Ontario and McMasters Universities Index Between Groups
|
20.6 score on a scale
Standard Deviation 11.91
|
20.57 score on a scale
Standard Deviation 11.54
|
21.72 score on a scale
Standard Deviation 9.80
|
PRIMARY outcome
Timeframe: 8-weeks from BaselinePopulation: Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and participants electing not to undergo voluntary quadriceps activation.
The investigators assessed voluntary quadriceps central activation ratio as a representative variable of lower extremity neuromuscular activation using the supra imposition technique. Quadriceps central activation ratio has been demonstrated to be significantly decreased in knee osteoarthritis (OA) compared to healthy, matched controls, and the investigators have reported acceptable measurement reliability (ICC2,k = 0.85)
Outcome measures
| Measure |
TENS and Therapeutic Exercise
n=26 Participants
Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
n=27 Participants
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
n=27 Participants
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
|---|---|---|---|
|
Mean Voluntary Quadriceps Activation as Measured by the Central Activation Ratio Expressed as a Percent of Full Activation
|
87.5 percentage of full activation
Standard Deviation 9.9
|
85.8 percentage of full activation
Standard Deviation 12.5
|
86.7 percentage of full activation
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: 8-weeks from BaselinePopulation: Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and participants electing not to undergo voluntary quadriceps activation.
Quadriceps strength was measured in Newton Meters normalized to body weight of the individuals. Strength was assessed in 90 degrees of knee flexion.
Outcome measures
| Measure |
TENS and Therapeutic Exercise
n=29 Participants
Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
n=22 Participants
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
n=27 Participants
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
|---|---|---|---|
|
Mean Maximal Quadriceps Strength as Measured by the Maximal Isometric Voluntary Contractions Normalized to Body Weight
|
1.5 Nm/kg body weight
Standard Deviation 0.58
|
1.53 Nm/kg body weight
Standard Deviation 0.48
|
1.54 Nm/kg body weight
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: 8-weeks from BaselinePopulation: Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and measurable outcomes were unable to be analyzed due to error in positioning of knee joint center marker.
The peak internal knee extension moment was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and normalized to the Body Weight\* height (m) of the individual during self selected gait speed.
Outcome measures
| Measure |
TENS and Therapeutic Exercise
n=18 Participants
Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
n=16 Participants
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
n=23 Participants
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
|---|---|---|---|
|
Mean Internal Knee Extension Moment During Walking Gait Measured in Nm/ Body Weight*m
|
.027 Nm/ Body Weight *m
Standard Deviation .015
|
.03 Nm/ Body Weight *m
Standard Deviation .015
|
.029 Nm/ Body Weight *m
Standard Deviation .013
|
PRIMARY outcome
Timeframe: 8-weeks from BaselinePopulation: Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and measurable outcomes were unable to be analyzed due to error in positioning of knee joint center marker.
The peak Knee Flexion Angle was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and during self selected gait speed.
Outcome measures
| Measure |
TENS and Therapeutic Exercise
n=18 Participants
Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist.
|
Sham TENS and Therapeutic Exercise
n=16 Participants
Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
Therapeutic Exercise Only
n=23 Participants
Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program.
|
|---|---|---|---|
|
Mean Knee Flexion Angle During Walking Gait Measured in Degrees of Knee Flexion
|
9.97 degrees
Standard Deviation 7.39
|
9.05 degrees
Standard Deviation 5.75
|
9.3 degrees
Standard Deviation 5.75
|
Adverse Events
TENS and Therapeutic Exercise
Sham TENS and Therapeutic Exercise
Therapeutic Exercise Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Pietrosimone, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place