The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): MSM 1000mg twice a day (6000 mgs); Placebo capsules twice a day
Intervention type(s): Drug; Other
Intervention description(s): 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 is a capsule filled with rice flour.
Other intervention name(s): Methylsulfonylmethane; Placebo
Intervention MeSH terms: Dimethyl sulfone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment