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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

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 20, 2014
Results First Submitted Date  ICMJE March 5, 2024
Results First Posted Date  ICMJE April 5, 2024
Last Update Posted Date April 5, 2024
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date June 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2024)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Pain Level [ Time Frame: 16 weeks ]
decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2024)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
  • Roland-Morris Disability Questionnaire [ Time Frame: 16 weeks ]
    improved symptoms of lower back pain
  • Pain Impact Questionnaire [ Time Frame: 16 weeks ]
    decrease in pain's interference with life activities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
Official Title  ICMJE The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
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.
Detailed Description

We will recruit male and female MOFMC DoD beneficiaries between the ages of 18-65 years old with symptoms of lower back pain from any of the clinics at the MOFMC at Nellis Air Force Base. Patients taking Muscle relaxers of any type, Non-steroidal anti-inflammatory agents (NSAIDs), Tramadol, Gabapentin, Pregabalin, agree to wash out for two weeks prior to entering the study.

Screening Visit:

  • Obtain signed Informed Consent Document and HIPAA Authorization.
  • Review inclusion/exclusion criteria.
  • Record: name, race ethnicity, race, date of birth, age, sex, height (in inches), weight (in pounds), blood pressure, email address, phone number, history of lower back surgeries, medical history, concomitant medications, and record the amount of naproxen prescribed as standard of care.
  • Subjects will have the following research-driven blood test drawn via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood drawn for each test) which include:

    • Women of childbearing potential will have a serum pregnancy test.
    • Comprehensive metabolic panel (liver function, renal function, plasma glucose tests).

      *Subjects who have had a comprehensive metabolic panel test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

    • Complete Blood Count. *Subjects who have had a complete blood count test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

Visit 1/Day 1 (within 1 week of Screening Visit):

  • Subjects will be randomized by the research coordinator. We will use a minimization/dynamic determination randomization (see attached explanation of minimization/dynamic determination) technique to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments:

    • Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen.
    • Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen.
  • Subjects will be asked to complete the following questionnaires:

    • RMDQ
    • PIQ-6
  • Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain".
  • Subjects will be given a 12 week supply of the study pills and reminded to take the pills as instructed.
  • Subjects will be given a Study Diary and will be instructed to record any missed dose of their study pills, record how much standard of care naproxen taken, and to bring the Study Diary to next visit.

Visit 2/Week 4:

  • Record: Weight (in pounds), blood pressure, history of lower back surgeries, medical history, and concomitant medications.
  • Subjects will be asked to complete the following questionnaires:

    • RMDQ
    • PIQ-6
  • Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain".
  • Research staff will record whether subject had any side effects to report.
  • Research staff will collect the subject's Study Diary, issue them a new one, and remind them to bring it with them to the next study visit.
  • Research staff will remind subjects to take the pills as instructed.
  • Subjects will have the following research-driven blood test drawn via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood drawn for each test) which include:

    • Comprehensive metabolic panel (liver function, renal function, plasma glucose tests).

      *Subjects who have had a comprehensive metabolic panel test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

    • Complete Blood Count.

      • Subjects who have had a complete blood count test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

Visit 3/Week 8:

  • Record: Weight (in pounds), blood pressure, history of lower back surgeries, medical history, and concomitant medications.
  • Subjects will be asked to complete the following questionnaires:

    • RMDQ
    • PIQ-6
  • Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain".
  • Research staff will record whether subject had any side effects to report.
  • Research staff will collect the subject's Study Diary, issue them a new one, and remind them to bring it with them to the next study visit.
  • Research staff will remind subjects to take the pills as instructed and to return the bottle to the research staff at the next visit.
  • Subjects will have the following research-driven blood test drawn via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood drawn for each test) which include:

    • Comprehensive metabolic panel (liver function, renal function, plasma glucose tests).

      *Subjects who have had a comprehensive metabolic panel test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

    • Complete Blood Count. *Subjects who have had a complete blood count test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

Visit 4/Week 12 *SUBJECTS STOP TAKING STUDY PILLS AT THIS VISIT:

  • Record: Weight (in pounds), blood pressure, history of lower back surgeries, medical history, and concomitant medications.
  • Subjects will be asked to complete the following questionnaires:

    • RMDQ
    • PIQ-6
  • Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain".
  • Research staff will record whether subject had any side effects to report.
  • Research staff will collect the subject's Study Diary.
  • Research staff will collect the study pills.
  • Subjects will have the following research-driven blood test drawn via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood drawn for each test) which include:

    • Comprehensive metabolic panel (liver function, renal function, plasma glucose tests).

      *Subjects who have had a comprehensive metabolic panel test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

    • Complete Blood Count. *Subjects who have had a complete blood count test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

Final Visit 5/Week 16:

  • Record: Weight (in pounds), blood pressure, history of lower back surgeries, medical history, and concomitant medications.
  • Subjects will be asked to complete the following questionnaires:

    • RMDQ
    • PIQ-6
  • Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain".
  • Research staff will record whether subject had any side effects to report.
  • Subjects will have the following research-driven blood test drawn via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood drawn for each test) which include:

    • Comprehensive metabolic panel (liver function, renal function, plasma glucose tests).

      *Subjects who have had a comprehensive metabolic panel test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.

    • Complete Blood Count. *Subjects who have had a complete blood count test within the one week prior to this visit will not need to have this test repeated unless they are abnormal.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
  • Other: Placebo capsules twice a day
    Placebo is a capsule filled with rice flour.
    Other Name: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: MSM 1000mg twice a day (6000 mgs)
  • Placebo Comparator: Placebo capsules twice a day
    Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen
    Intervention: Other: Placebo capsules twice a day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 5, 2018
Actual Primary Completion Date June 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02268305
Other Study ID Numbers  ICMJE FWH20140075H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mike O'Callaghan Military Hospital
Original Responsible Party Paul Crawford, Mike O'Callaghan Military Hospital, Research Director
Current Study Sponsor  ICMJE Mike O'Callaghan Military Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Crawford, MD Mike O'Callaghan Federal Medical Center
PRS Account Mike O'Callaghan Military Hospital
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP