Trial Outcomes & Findings for Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis (NCT NCT05160532)
NCT ID: NCT05160532
Last Updated: 2026-06-30
Results Overview
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-96, with higher scores indicating worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline; Week 4; Week 8; Week 16; Week 26; Week 52
Results posted on
2026-06-30
Participant Flow
Subjects were recruited from the Family Medicine, General Internal Medicine, Orthopedic Medicine and Physical Medicine and Rehabilitation Departments at the Mayo Clinic in Arizona and Mayo Clinic Health Systems in Minnesota and Wisconsin. A short informational meeting was held with providers at their department meetings to discuss the trial including inclusion and exclusion criteria. Social media geotargeted advertisements were posted on Mayo Clinic's Facebook and Twitter pages as well.
5 subjects were enrolled but withdrew prior to randomization.
Participant milestones
| Measure |
Four Injections of Placebo
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Four Injections of Placebo
n=11 Participants
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 Participants
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
n=10 Participants
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 Participants
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.3 years
n=20 Participants
|
66.6 years
n=20 Participants
|
67.6 years
n=40 Participants
|
69.0 years
n=6 Participants
|
67.9 years
n=7 Participants
|
|
Sex/Gender, Customized
Males
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
11 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Females
|
8 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
31 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Prefer Not to Answer
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
43 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
42 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 4; Week 8; Week 16; Week 26; Week 52Population: 1 sbjt in 2DPT/2placebo arm didnt completed WOMAC at baseline \& week 4. 1 in 4 placebo arm, 1 in 1DPT/3placebo, \& 1 in 4DPT arm didnt complete WOMAC at week 4 \& week 16. 1 in 1DPT/3placebo arm \& 1 in 4DPT arm didnt complete WOMAC at week 8. 2 in 2DPT/2placebo arm didnt complete WOMAC at week 16. 2 in 4placebo arm, 2 in 1DPT/3placebo arm \& 3 in 4DPT arm didnt complete WOMAC at week 26. 3 in 2DPT/2placebo arm didnt complete WOMAC at week 26. 5 in 2DPT/2placebo arm didnt complete WOMAC at week 52
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-96, with higher scores indicating worse outcome.
Outcome measures
| Measure |
Four Injections of Placebo
n=11 Participants
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 Participants
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
n=10 Participants
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 Participants
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Baseline
|
32.1 score on a scale
Standard Deviation 18.2
|
34.5 score on a scale
Standard Deviation 9.0
|
39.7 score on a scale
Standard Deviation 17.4
|
32.7 score on a scale
Standard Deviation 15.7
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Week 4
|
29.7 score on a scale
Standard Deviation 16.9
|
17.9 score on a scale
Standard Deviation 14.3
|
32.0 score on a scale
Standard Deviation 13.7
|
26.3 score on a scale
Standard Deviation 14.5
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Week 8
|
25.4 score on a scale
Standard Deviation 14.5
|
19.8 score on a scale
Standard Deviation 16.3
|
29.4 score on a scale
Standard Deviation 12.4
|
19.4 score on a scale
Standard Deviation 13.2
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Week 16
|
24.9 score on a scale
Standard Deviation 14.0
|
29.2 score on a scale
Standard Deviation 23.3
|
24.1 score on a scale
Standard Deviation 15.3
|
15.1 score on a scale
Standard Deviation 12.6
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Week 26
|
19.9 score on a scale
Standard Deviation 12.6
|
33.0 score on a scale
Standard Deviation 23.6
|
28.3 score on a scale
Standard Deviation 21.2
|
11.4 score on a scale
Standard Deviation 11.4
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Week 52
|
18.7 score on a scale
Standard Deviation 5.0
|
19.2 score on a scale
Standard Deviation 18.7
|
29.6 score on a scale
Standard Deviation 20.0
|
16.9 score on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52Population: 1 sbjt in 2 DPT/2 placebo arm didnt completed VAS at baseline \& week 4. 1 in 4 placebo arm, 1 in 1 DPT/3 placebo, \& 1 in 4 DPT arm didnt complete VAS at week 4 \& week 16. 1 in 1 DPT/3 placebo arm \& 1 in 4 DPT arm didnt complete VAS at week 8. 2 in 2 DPT/2 placebo arm didnt complete VAS at week 16. 2 in 4 placebo arm, 2 in 1 DPT/3 placebo arm \& 3 in 4 DPT arm didnt complete VAS at week 26. 3 in 2 DPT/2 placebo arm didnt complete VAS at week 26. 5 in 2DPT/2placebo arm didnt complete VAS at week 52
Measured using a visual analogue scale with 0 = no pain and 10=worst pain with higher scores indicating worse pain.
Outcome measures
| Measure |
Four Injections of Placebo
n=11 Participants
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 Participants
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
n=10 Participants
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 Participants
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
|---|---|---|---|---|
|
Change in Pain
Week 16
|
3.00 score on a scale
Standard Deviation 2.06
|
2.60 score on a scale
Standard Deviation 2.17
|
2.13 score on a scale
Standard Deviation 1.13
|
1.60 score on a scale
Standard Deviation 0.84
|
|
Change in Pain
Week 26
|
1.67 score on a scale
Standard Deviation 1.41
|
3.33 score on a scale
Standard Deviation 2.40
|
2.57 score on a scale
Standard Deviation 2.23
|
1.63 score on a scale
Standard Deviation 1.41
|
|
Change in Pain
Week 52
|
2.78 score on a scale
Standard Deviation 1.72
|
2.22 score on a scale
Standard Deviation 1.72
|
3.00 score on a scale
Standard Deviation 1.41
|
2.13 score on a scale
Standard Deviation 1.73
|
|
Change in Pain
Week 8
|
3.46 score on a scale
Standard Deviation 1.64
|
2.00 score on a scale
Standard Deviation 1.50
|
3.10 score on a scale
Standard Deviation 2.03
|
2.10 score on a scale
Standard Deviation 1.37
|
|
Change in Pain
Baseline
|
3.27 score on a scale
Standard Deviation 2.41
|
3.64 score on a scale
Standard Deviation 1.21
|
3.75 score on a scale
Standard Deviation 1.49
|
3.91 score on a scale
Standard Deviation 1.30
|
|
Change in Pain
Week 4
|
3.20 score on a scale
Standard Deviation 1.81
|
1.70 score on a scale
Standard Deviation 1.34
|
2.89 score on a scale
Standard Deviation 1.36
|
2.90 score on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52Population: 1 sbjt in 2DPT/2placebo arm didnt completed WOMAC at baseline \& week 4. 1 in 4 placebo arm, 1 in 1DPT/3placebo, \& 1 in 4DPT arm didnt complete WOMAC at week 4 \& week 16. 1 in 1DPT/3placebo arm \& 1 in 4DPT arm didnt complete WOMAC at week 8. 2 in 2DPT/2placebo arm didnt complete WOMAC at week 16. 2 in 4placebo arm, 2 in 1DPT/3placebo arm \& 3 in 4DPT arm didnt complete WOMAC at week 26. 3 in 2DPT/2placebo arm didnt complete WOMAC at week 26. 5 in 2DPT/2placebo arm didnt complete WOMAC at week 52
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function in individuals with knee OA. Total scores range from 0-68, with higher scores indicating worse physical function.
Outcome measures
| Measure |
Four Injections of Placebo
n=11 Participants
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 Participants
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
n=10 Participants
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 Participants
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Baseline
|
21.64 score on a scale
Standard Deviation 13.08
|
23.73 score on a scale
Standard Deviation 7.25
|
28.67 score on a scale
Standard Deviation 13.63
|
22.55 score on a scale
Standard Deviation 10.87
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Week 4
|
20.10 score on a scale
Standard Deviation 11.37
|
12.70 score on a scale
Standard Deviation 10.05
|
22.89 score on a scale
Standard Deviation 10.36
|
18.50 score on a scale
Standard Deviation 9.46
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Week 8
|
16.82 score on a scale
Standard Deviation 10.60
|
13.20 score on a scale
Standard Deviation 11.60
|
20.10 score on a scale
Standard Deviation 8.77
|
14.00 score on a scale
Standard Deviation 10.30
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Week 16
|
16.30 score on a scale
Standard Deviation 10.77
|
21.00 score on a scale
Standard Deviation 17.94
|
17.63 score on a scale
Standard Deviation 10.95
|
10.50 score on a scale
Standard Deviation 8.75
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Week 26
|
13.67 score on a scale
Standard Deviation 8.78
|
21.89 score on a scale
Standard Deviation 16.10
|
20.14 score on a scale
Standard Deviation 14.69
|
7.38 score on a scale
Standard Deviation 7.91
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score
Week 52
|
12.11 score on a scale
Standard Deviation 3.89
|
13.67 score on a scale
Standard Deviation 13.72
|
21.40 score on a scale
Standard Deviation 14.84
|
11.00 score on a scale
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52Population: 1 sbjt in 2DPT/2placebo arm didnt completed WOMAC at baseline \& week 4. 1 in 4 placebo arm, 1 in 1DPT/3placebo, \& 1 in 4DPT arm didnt complete WOMAC at week 4 \& week 16. 1 in 1DPT/3placebo arm \& 1 in 4DPT arm didnt complete WOMAC at week 8. 2 in 2DPT/2placebo arm didnt complete WOMAC at week 16. 2 in 4placebo arm, 2 in 1DPT/3placebo arm \& 3 in 4DPT arm didnt complete WOMAC at week 26. 3 in 2DPT/2placebo arm didnt complete WOMAC at week 26. 5 in 2DPT/2placebo arm didnt complete WOMAC at week 52
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure stiffness in individuals with knee OA. Total scores range from 0-8, with higher scores indicating worse stiffness.
Outcome measures
| Measure |
Four Injections of Placebo
n=11 Participants
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 Participants
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
n=10 Participants
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 Participants
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Baseline
|
3.91 score on a scale
Standard Deviation 2.43
|
3.64 score on a scale
Standard Deviation 1.70
|
3.67 score on a scale
Standard Deviation 1.87
|
3.73 score on a scale
Standard Deviation 2.28
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Week 4
|
3.50 score on a scale
Standard Deviation 2.37
|
2.10 score on a scale
Standard Deviation 1.73
|
2.67 score on a scale
Standard Deviation 1.41
|
2.70 score on a scale
Standard Deviation 2.36
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Week 8
|
3.18 score on a scale
Standard Deviation 1.47
|
2.10 score on a scale
Standard Deviation 1.52
|
2.80 score on a scale
Standard Deviation 1.48
|
2.40 score on a scale
Standard Deviation 1.43
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Week 16
|
3.40 score on a scale
Standard Deviation 2.17
|
2.50 score on a scale
Standard Deviation 1.84
|
2.00 score on a scale
Standard Deviation 1.77
|
1.90 score on a scale
Standard Deviation 1.73
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Week 26
|
2.67 score on a scale
Standard Deviation 2.29
|
3.22 score on a scale
Standard Deviation 2.73
|
3.00 score on a scale
Standard Deviation 2.45
|
1.13 score on a scale
Standard Deviation 1.13
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Week 52
|
2.33 score on a scale
Standard Deviation 1.94
|
1.89 score on a scale
Standard Deviation 1.45
|
2.60 score on a scale
Standard Deviation 1.52
|
2.38 score on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 16, Week 26, Week 52Population: 1 sbjt in 2DPT/2placebo arm didnt completed WOMAC at baseline \& week 4. 1 in 4 placebo arm, 1 in 1DPT/3placebo, \& 1 in 4DPT arm didnt complete WOMAC at week 4 \& week 16. 1 in 1DPT/3placebo arm \& 1 in 4DPT arm didnt complete WOMAC at week 8. 2 in 2DPT/2placebo arm didnt complete WOMAC at week 16. 2 in 4placebo arm, 2 in 1DPT/3placebo arm \& 3 in 4DPT arm didnt complete WOMAC at week 26. 3 in 2DPT/2placebo arm didnt complete WOMAC at week 26. 5 in 2DPT/2placebo arm didnt complete WOMAC at week 52
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure pain in individuals with knee OA. Total scores range from 0-20, with higher scores indicating worse pain.
Outcome measures
| Measure |
Four Injections of Placebo
n=11 Participants
Subjects received four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 Participants
Subjects received one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
Two Injections of DPT and Two Injections of Placebo
n=10 Participants
Subjects received two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 Participants
Subjects received four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Baseline
|
6.55 score on a scale
Standard Deviation 4.32
|
7.09 score on a scale
Standard Deviation 2.02
|
7.33 score on a scale
Standard Deviation 3.61
|
6.46 score on a scale
Standard Deviation 3.56
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Week 4
|
6.10 score on a scale
Standard Deviation 4.04
|
3.10 score on a scale
Standard Deviation 3.14
|
6.44 score on a scale
Standard Deviation 3.09
|
5.10 score on a scale
Standard Deviation 2.96
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Week 8
|
5.36 score on a scale
Standard Deviation 3.36
|
4.50 score on a scale
Standard Deviation 3.84
|
6.50 score on a scale
Standard Deviation 4.25
|
3.00 score on a scale
Standard Deviation 2.11
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Week 16
|
5.20 score on a scale
Standard Deviation 2.62
|
5.70 score on a scale
Standard Deviation 4.52
|
4.50 score on a scale
Standard Deviation 3.42
|
2.70 score on a scale
Standard Deviation 2.71
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Week 26
|
3.56 score on a scale
Standard Deviation 2.19
|
7.89 score on a scale
Standard Deviation 5.26
|
5.14 score on a scale
Standard Deviation 5.08
|
2.88 score on a scale
Standard Deviation 3.27
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Week 52
|
4.22 score on a scale
Standard Deviation 1.56
|
3.67 score on a scale
Standard Deviation 3.84
|
5.60 score on a scale
Standard Deviation 4.10
|
3.50 score on a scale
Standard Deviation 2.67
|
Adverse Events
Two Injections of DPT and Two Injections of Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Four Injections of DPT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Four Injections of Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
One Injection of DPT and Three Injections of Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Two Injections of DPT and Two Injections of Placebo
n=10 participants at risk
Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
|
Four Injections of DPT
n=11 participants at risk
Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
|
Four Injections of Placebo
n=11 participants at risk
Subjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
|
One Injection of DPT and Three Injections of Placebo
n=11 participants at risk
Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Right knee effusion
|
0.00%
0/10 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
0.00%
0/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
9.1%
1/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
0.00%
0/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
|
Musculoskeletal and connective tissue disorders
Right heel pain
|
0.00%
0/10 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
0.00%
0/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
0.00%
0/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
9.1%
1/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
0.00%
0/10 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
9.1%
1/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
0.00%
0/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
0.00%
0/11 • Adverse events were collected from the date the participant received the first dose of medication through study completion, approximately 1 year.
Adverse events were collected through patient diaries.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place