Clinical trial NCT02268305: The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
Official title: The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2014-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain Level
timeFrame: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: 16 weeks (Weeks 0, 4, 8, 12, and 16)
measure: Pain Impact Questionnaire-6
timeFrame: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Federal Medical Center
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Federal Medical Center
name: Paul Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References: