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

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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

Brief Summary:
The investigators are studying whether MSM plus standard of care naproxen improves symptoms of lower back pain compared to standard of care naproxen plus placebo. Subjects will be randomized into 1 of 2 groups. Group 1 will take by mouth 6000 milligrams (mgs) of MSM plus standard of care naproxen. Group 2 will take by mouth placebo capsules plus standard of care naproxen. Subjects will be instructed to take their study pills for 12 weeks and record on a study diary. They will then be followed up for one final visit 4 weeks later. RMDQ, PIQ-6, pain level, comprehensive metabolic panel (CMP), complete blood count (CBC) will be assessed at 4 week intervals for 12 weeks. Subjects' participation will last 16 weeks.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: MSM 1000mg twice a day (6000 mgs) Other: Placebo capsules twice a day Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 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
Drug: 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.
Other Name: Methylsulfonylmethane

Placebo Comparator: Placebo capsules twice a day
Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
Other: Placebo capsules twice a day
Placebo is a capsule filled with rice flour.
Other Name: Placebo




Primary Outcome Measures :
  1. Pain Level [ Time Frame: 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)


Secondary Outcome Measures :
  1. Roland-Morris Disability Questionnaire [ Time Frame: 16 weeks (Weeks 0, 4, 8, 12, and 16) ]
    symptoms of lower back pain. 0 (no disability) to 24 (max. disability).

  2. Pain Impact Questionnaire-6 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

DoD beneficiaries between the ages of 18-65 years old Symptoms of Low Back Pain greater than 12 weeks duration Patients with a history of lower back surgery may be included

Exclusion:

DoD beneficiaries less than 18 years old or greater than 65 years old

Lower back pain caused by any of the following:

Infection Tumor Osteoporosis Ankylosing spondylitis Fracture Deformity Inflammatory process Cauda equina syndrome Treated or untreated central nervous system impairment

Meeting the criteria for surgery, including:

progressive motor deficit sphincter impairment from neurological cause disabling sciatic pain (in the absence of backache) lasting 6 weeks or more that is attributed to a compromised nerve root and demonstrated by magnetic resonance imaging or computed tomography Oncologic disease during the previous 5 years Unexplained weight loss, fever, or chills Diagnosed upper urinary tract infection within last 28 days Patients identified during standard of care interview to have a history of intravenous drug use.

Immunocompromised host

A severe comorbidity to include:

determining overall well-being (e.g. painful disabling arthritic hip joints) Cirrhosis Ongoing dialysis Radiating symptoms to lower extremities (sciatica) History of bleeding disorders History of high blood pressure History of heart, kidney, liver or ulcer disease Allergic to analgesics or Non-steroidal anti inflammatory agents (NSAIDs) Pregnant or breastfeeding Initial pain rating of greater than 8/10 on initial intake evaluation If any of the components of the comprehensive metabolic panel are outside the Nellis clinical laboratory reference ranges, the subject will be excluded from the study

If any of these four components of the complete blood count are outside of the Nellis clinical laboratory reference ranges, the subject will be excluded from the study:

White blood cell count Hemoglobin Hematocrit Platelets

Patients taking any of the following medications are excluded from participating, unless they agree to wash out for two weeks prior to entering the study:

Muscle relaxers of any type Non-steroidal anti-inflammatory agents (NSAIDs) * Patients taking naproxen must agree to wash out for two weeks prior to entering the study, but can begin taking it again, as prescribed, after Visit 1 where a baseline pain assessment is performed.

Tramadol Gabapentin Pregabalin Glucosamine Narcotic pain medications


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268305


Locations
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United States, Nevada
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
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Principal Investigator: Paul Crawford, MD Mike O'Callaghan Federal Medical Center
  Study Documents (Full-Text)

Documents provided by Mike O'Callaghan Military Hospital:
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Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02268305    
Other Study ID Numbers: FWH20140075H
First Posted: October 20, 2014    Key Record Dates
Results First Posted: April 5, 2024
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Dimethyl sulfone
Anti-Inflammatory Agents