Low Back PainPhase 3NCT02268305
The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain
A Phase 3 study testing MSM 1000mg twice a day (6000 mgs) in people with Low Back Pain, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- MSM 1000mg twice a day (6000 mgs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 5 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- MSM 1000mg twice a day (6000 mgs), Placebo capsules twice a day
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSM 1000mg twice a day (6000 mgs)Drug
Also called Methylsulfonylmethane
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 capsules twice a dayOther
Also called Placebo
Placebo is a capsule filled with rice flour.
| Study group | Role | What they receive |
|---|---|---|
| MSM 1000mg twice a day (6000 mgs) | Experimental | Group 1 will take by mouth three 1000 mg capsules twice a day (6000 mgs) of MSM plus standard of care naproxen Receives: Drug: MSM 1000mg twice a day (6000 mgs) |
| Placebo capsules twice a day | Placebo comparator | Group 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen Receives: Other: Placebo capsules twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
decrease in pain via analogue pain scale of 0-10 (with 10 being the worst pain)
Measured: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Secondary outcomes (2)
Roland-Morris Disability Questionnaire
symptoms of lower back pain. 0 (no disability) to 24 (max. disability).
Measured: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Pain Impact Questionnaire-6
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.
Measured: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Crawford, MD, Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268305
- Sponsor's protocol ID
- FWH20140075H
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2014
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain.
- ClinicalTrials.gov ID
- NCT02268305
- Acronym / sponsor ID
- FWH20140075H
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Feb 2015 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSM 1000mg twice a day (6000 mgs) | Experimental | Drug: 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 |
| Placebo capsules twice a day | Placebo comparator | Other: Placebo capsules twice a dayGroup 2 will take by mouth three placebo capsules twice a day plus standard of care naproxen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- DoD beneficiaries less than 18 years old or greater than 65 years old
- Infection Tumor Osteoporosis Ankylosing spondylitis Fracture Deformity Inflammatory process Cauda equina syndrome Treated or untreated central nervous system impairment
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSM 1000mg twice a day (6000 mgs)Also: MethylsulfonylmethaneMSM 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. | Drug | MSM 1000mg twice a day (6000 mgs) |
| Placebo capsules twice a dayAlso: PlaceboPlacebo is a capsule filled with rice flour. | Other | Placebo capsules twice a day |
Primary outcome
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)
2 secondary outcomes
Roland-Morris Disability Questionnaire
Time frame: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Pain Impact Questionnaire-6
Time frame: 16 weeks (Weeks 0, 4, 8, 12, and 16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crawford, MD principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MSM 1000mg twice a day (6000 mgs) in people with Low Back Pain, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: 16 weeks (Weeks 0, 4, 8, 12, and 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.