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

NCT02268305 | Completed Phase 3 Results

• 1 other identifier: FWH20140075H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain Level

  decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)

  16 weeks (Weeks 0, 4, 8, 12, and 16)

Secondary Outcomes (2)

• Roland-Morris Disability Questionnaire

  16 weeks (Weeks 0, 4, 8, 12, and 16)

• Pain Impact Questionnaire-6

  16 weeks (Weeks 0, 4, 8, 12, and 16)

Study Arms (2)

MSM 1000mg twice a day (6000 mgs)

EXPERIMENTAL

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)

Placebo capsules twice a day

PLACEBO COMPARATOR

Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen

Other: Placebo capsules twice a day

Interventions

MSM 1000mg twice a day (6000 mgs) DRUG

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.

Also known as: Methylsulfonylmethane

MSM 1000mg twice a day (6000 mgs)

Placebo capsules twice a day OTHER

Placebo is a capsule filled with rice flour.

Also known as: Placebo

Placebo capsules twice a day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

dimethyl sulfone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMH

amanda.j.crawford.ctr@health.mil

7026533583

Study Officials

• Paul Crawford, MD

  Mike O'Callaghan Federal Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 20, 2014
• Study Start: February 1, 2015
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)