The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/29/2018 |
| Start Date: | February 2015 |
| End Date: | June 5, 2018 |
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
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.
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.
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.
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.
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
We found this trial at
1
site
4700 North Las Vegas Boulevard
Nellis Air Force Base, Nevada 89191
Nellis Air Force Base, Nevada 89191
Principal Investigator: Paul Crawford, MD
Phone: 702-653-3298
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