Knee OsteoarthritisNCT01188213
Efficacy of Methylsulfonylmethane Supplementation on Osteoarthritis of The Knee: A Randomized Controlled Study
A study testing Methylsulfonylmethane (MSM) in people with Knee Osteoarthritis, run by Assaf-Harofeh Medical Center.
Trial summary
The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Methylsulfonylmethane (MSM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- symptomatic knee OA for at least 6 months according to the clinical criteria of the American College of Rheumatology (ACR)
- radiographic confirmed knee OA according to the Kellgren \& Lawrence scale
Who cannot join
- acute septic arthritis
- inflammatory arthritis
- any other type of arthritis
- history of knee buckling or recent knee injury
- lack of physical or mental bility to perform or comply with the treatment procedure
- diabetes mellitus
Show all 9Show fewer
- fibromyalgia or other chronic pain syndromes
- concurrent anti-coagulant/anti-platelet drugs
- arthroscopy or intra-articular injections in the previous 3 months
About this study
The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Methylsulfonylmethane (MSM)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylsulfonylmethane (MSM)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Purified MSM | Experimental | Not described Receives: Dietary Supplement: Methylsulfonylmethane (MSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 N/A
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188213
- Sponsor's protocol ID
- 13/05
- Status last verified
- May 2005
- First submitted
- 21 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Debbi EM, Agar G, Fichman G, Ziv YB, Kardosh R, Halperin N, Elbaz A, Beer Y, Debi R. Efficacy of methylsulfonylmethane supplementation on osteoarthritis of the knee: a randomized controlled study. BMC Complement Altern Med. 2011 Jun 27;11:50. doi: 10.1186/1472-6882-11-50.
PubMed 21708034
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylsulfonylmethane Supplementation on Osteoarthritis of The Knee: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01188213
- Acronym / sponsor ID
- 13/05
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Purified MSM | Experimental | Dietary Supplement: Methylsulfonylmethane (MSM) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic knee OA for at least 6 months according to the clinical criteria of the American College of Rheumatology (ACR)
- radiographic confirmed knee OA according to the Kellgren \& Lawrence scale
Key exclusion criteria (9 listed)
- acute septic arthritis
- inflammatory arthritis
- any other type of arthritis
- history of knee buckling or recent knee injury
- lack of physical or mental bility to perform or comply with the treatment procedure
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 |
|---|---|---|
| Methylsulfonylmethane (MSM) | Dietary supplement | Purified MSM |
Primary outcome
WOMAC questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
- Derived from this study: PubMed 21708034Debbi EM, Agar G, Fichman G, Ziv YB, Kardosh R, Halperin N, Elbaz A, Beer Y, Debi R. Efficacy of methylsulfonylmethane supplementation on osteoarthritis of the knee: a randomized controlled study. BMC Complement Altern Med. 2011 Jun 27;11:50. doi: 10.1186/1472-6882-11-50.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Methylsulfonylmethane (MSM) in people with Knee Osteoarthritis, run by Assaf-Harofeh Medical Center.
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 2 inclusion and 9 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 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188213, which also lists 1 linked publication.
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 25 Aug 2010.