Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT02268305
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
Sponsor:
Mike O'Callaghan Military Hospital
Organization:
Study Overview
Official Title:
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: