Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage (msm)

April 17, 2013 updated by: Thomas Pagonis, G.Papanikolaou Research Group

The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte

To delineate the effect of MSM on osteoarthritis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 57010
        • Recruiting
        • G. Papanikolaou Hospital
        • Contact:
          • Panagiotis Givisis, MD, PhD
          • Phone Number: 00306945264010
        • Principal Investigator:
          • Thomas Pagonis, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Knee and hip OA
  • men and women >45 years of age

Exclusion Criteria:

  • any other type of arthritis
  • chronic pain syndrome
  • arthroscopic surgery in the past 8 months
  • intra-articular corticosteroidsin the past 8 months
  • hyaluronic acid injections in the past 8 months
  • narcotic pain killers use
  • renal or hepatic disease
  • body mass index (BMI) >45 kg/m2
  • cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSM group
Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
Drug: MethylSulfonylMethane (MSM)
Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
Placebo Comparator: Placebo Group
Placebo 3 gr twice a day for 26 weeks (6 gr/day total)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with improved Mobility
Time Frame: 26 weeks
Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA were divided in 2 groups. Intervention was either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured were the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC)
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: 26 weeks
On the same two groups (MSM and Placebo)we measured the improvement of quality of life through pain relief as measured by use of SF-36 (overall health-related quality of life)
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G.Papanikolaou Research Group

Investigators

  • Principal Investigator: Thomas Pagonis, MD, PhD, Aristotle's University of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • msm2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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