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The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02268305
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : April 5, 2024
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: MSM 1000mg twice a day (6000 mgs)
Other: Placebo capsules twice a day
Enrollment 100
Recruitment Details  
Pre-assignment Details 86 subjects analyzed.
Arm/Group Title MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 50 50
Completed 46 40
Not Completed 4 10
Arm/Group Title MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 46 40 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 40 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
 100.0%
40
 100.0%
86
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 40 participants 86 participants
Female
16
  34.8%
11
  27.5%
27
  31.4%
Male
30
  65.2%
29
  72.5%
59
  68.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 40 participants 86 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   6.5%
2
   5.0%
5
   5.8%
Native Hawaiian or Other Pacific Islander
1
   2.2%
0
   0.0%
1
   1.2%
Black or African American
9
  19.6%
6
  15.0%
15
  17.4%
White
21
  45.7%
25
  62.5%
46
  53.5%
More than one race
4
   8.7%
5
  12.5%
9
  10.5%
Unknown or Not Reported
8
  17.4%
2
   5.0%
10
  11.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 40 participants 86 participants
46 40 86
1.Primary Outcome
Title Pain Level
Hide Description decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)
Time Frame 16 weeks (Weeks 0, 4, 8, 12, and 16)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 46 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Visual Analogue Scale Week 0 3.4  (1.5) 3.7  (2.0)
Visual Analogue Scale Week 4 2.8  (1.5) 2.9  (2.5)
Visual Analogue Scale Week 8 3.0  (1.6) 3.1  (2.4)
Visual Analogue Scale Week 12 2.7  (1.4) 3.2  (2.4)
Visual Analogue Scale Week 16 3.0  (1.7) 3.4  (2.4)
2.Secondary Outcome
Title Roland-Morris Disability Questionnaire
Hide Description symptoms of lower back pain. 0 (no disability) to 24 (max. disability).
Time Frame 16 weeks (Weeks 0, 4, 8, 12, and 16)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 46 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Roland Morris Disability Questionnaire Week 0 8.0  (4.2) 8.4  (5.1)
Roland Morris Disability Questionnaire Week 4 5.8  (4.3) 6.9  (5.8)
Roland Morris Disability Questionnaire Week 8 5.5  (3.9) 6.7  (5.5)
Roland Morris Disability Questionnaire Week 12 5.4  (4.2) 6.9  (4.2)
Roland Morris Disability Questionnaire Week 16 5.9  (4.4) 6.8  (5.7)
3.Secondary Outcome
Title Pain Impact Questionnaire-6
Hide Description 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.
Time Frame 16 weeks (Weeks 0, 4, 8, 12, and 16)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 46 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pain Impact Questionnaire Week 0 60.8  (5.0) 60.2  (6.9)
Pain Impact Questionnaire Week 4 56.4  (6.5) 56.7  (8.5)
Pain Impact Questionnaire Week 8 56.0  (6.4) 57.2  (9.6)
Pain Impact Questionnaire Week 12 56.5  (6.4) 56.3  (9.3)
Pain Impact Questionnaire Week 16 57.0  (6.9) 57.8  (8.6)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Hide Arm/Group Description

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.

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.

All-Cause Mortality
MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MSM 1000mg Twice a Day (6000 Mgs) Placebo Capsules Twice a Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      2/50 (4.00%)    
Gastrointestinal disorders     
colitis *  1/50 (2.00%)  1 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders     
musculoskeletal pain *  1/50 (2.00%)  1 2/50 (4.00%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amanda Crawford
Organization: MOMH
Phone: 7026533583
EMail: amanda.j.crawford.ctr@health.mil
Layout table for additonal information
Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02268305    
Other Study ID Numbers: FWH20140075H
First Submitted: October 10, 2014
First Posted: October 20, 2014
Results First Submitted: March 5, 2024
Results First Posted: April 5, 2024
Last Update Posted: April 5, 2024