Trial Outcomes & Findings for The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain (NCT NCT02268305)
NCT ID: NCT02268305
Last Updated: 2024-04-05
Results Overview
decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
16 weeks (Weeks 0, 4, 8, 12, and 16)
Results posted on
2024-04-05
Participant Flow
86 subjects analyzed.
Participant milestones
| Measure |
MSM 1000mg Twice a Day (6000 Mgs)
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
|
Placebo Capsules Twice a Day
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Placebo capsules twice a day: Placebo is a capsule filled with rice flour.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
Baseline characteristics by cohort
| Measure |
MSM 1000mg Twice a Day (6000 Mgs)
n=46 Participants
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
|
Placebo Capsules Twice a Day
n=40 Participants
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Placebo capsules twice a day: Placebo is a capsule filled with rice flour.
|
Total
n=86 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
|
46 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
86 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
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
40 participants
n=7 Participants
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks (Weeks 0, 4, 8, 12, and 16)decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)
Outcome measures
| Measure |
MSM 1000mg Twice a Day (6000 Mgs)
n=46 Participants
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
|
Placebo Capsules Twice a Day
n=40 Participants
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Placebo capsules twice a day: Placebo is a capsule filled with rice flour.
|
|---|---|---|
|
Pain Level
Visual Analogue Scale Week 0
|
3.4 score on a scale
Standard Deviation 1.5
|
3.7 score on a scale
Standard Deviation 2.0
|
|
Pain Level
Visual Analogue Scale Week 4
|
2.8 score on a scale
Standard Deviation 1.5
|
2.9 score on a scale
Standard Deviation 2.5
|
|
Pain Level
Visual Analogue Scale Week 8
|
3.0 score on a scale
Standard Deviation 1.6
|
3.1 score on a scale
Standard Deviation 2.4
|
|
Pain Level
Visual Analogue Scale Week 12
|
2.7 score on a scale
Standard Deviation 1.4
|
3.2 score on a scale
Standard Deviation 2.4
|
|
Pain Level
Visual Analogue Scale Week 16
|
3.0 score on a scale
Standard Deviation 1.7
|
3.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 16 weeks (Weeks 0, 4, 8, 12, and 16)symptoms of lower back pain. 0 (no disability) to 24 (max. disability).
Outcome measures
| Measure |
MSM 1000mg Twice a Day (6000 Mgs)
n=46 Participants
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
|
Placebo Capsules Twice a Day
n=40 Participants
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Placebo capsules twice a day: Placebo is a capsule filled with rice flour.
|
|---|---|---|
|
Roland-Morris Disability Questionnaire
Roland Morris Disability Questionnaire Week 0
|
8.0 score on a scale
Standard Deviation 4.2
|
8.4 score on a scale
Standard Deviation 5.1
|
|
Roland-Morris Disability Questionnaire
Roland Morris Disability Questionnaire Week 4
|
5.8 score on a scale
Standard Deviation 4.3
|
6.9 score on a scale
Standard Deviation 5.8
|
|
Roland-Morris Disability Questionnaire
Roland Morris Disability Questionnaire Week 8
|
5.5 score on a scale
Standard Deviation 3.9
|
6.7 score on a scale
Standard Deviation 5.5
|
|
Roland-Morris Disability Questionnaire
Roland Morris Disability Questionnaire Week 12
|
5.4 score on a scale
Standard Deviation 4.2
|
6.9 score on a scale
Standard Deviation 4.2
|
|
Roland-Morris Disability Questionnaire
Roland Morris Disability Questionnaire Week 16
|
5.9 score on a scale
Standard Deviation 4.4
|
6.8 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 16 weeks (Weeks 0, 4, 8, 12, and 16)6-item questionnaire measuring pain's interference with life activities. The total possible score of the PIQ-6 ranges from 40-78 points, where lower scores indicate less pain interference.
Outcome measures
| Measure |
MSM 1000mg Twice a Day (6000 Mgs)
n=46 Participants
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
|
Placebo Capsules Twice a Day
n=40 Participants
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Placebo capsules twice a day: Placebo is a capsule filled with rice flour.
|
|---|---|---|
|
Pain Impact Questionnaire-6
Pain Impact Questionnaire Week 0
|
60.8 score on a scale
Standard Deviation 5.0
|
60.2 score on a scale
Standard Deviation 6.9
|
|
Pain Impact Questionnaire-6
Pain Impact Questionnaire Week 4
|
56.4 score on a scale
Standard Deviation 6.5
|
56.7 score on a scale
Standard Deviation 8.5
|
|
Pain Impact Questionnaire-6
Pain Impact Questionnaire Week 8
|
56.0 score on a scale
Standard Deviation 6.4
|
57.2 score on a scale
Standard Deviation 9.6
|
|
Pain Impact Questionnaire-6
Pain Impact Questionnaire Week 12
|
56.5 score on a scale
Standard Deviation 6.4
|
56.3 score on a scale
Standard Deviation 9.3
|
|
Pain Impact Questionnaire-6
Pain Impact Questionnaire Week 16
|
57.0 score on a scale
Standard Deviation 6.9
|
57.8 score on a scale
Standard Deviation 8.6
|
Adverse Events
MSM 1000mg Twice a Day (6000 Mgs)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Capsules Twice a Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MSM 1000mg Twice a Day (6000 Mgs)
n=50 participants at risk
Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen
MSM 1000mg twice a day (6000 mgs): MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
|
Placebo Capsules Twice a Day
n=50 participants at risk
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Placebo capsules twice a day: Placebo is a capsule filled with rice flour.
|
|---|---|---|
|
Gastrointestinal disorders
colitis
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
0.00%
0/50 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
2.0%
1/50 • Number of events 1 • 16 weeks
|
4.0%
2/50 • Number of events 2 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place