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Association Between Hypermobility and Chronic Musculoskeletal Pain (HAMS)

This study has been completed.
Sponsor:
Information provided by:
Amrita Institute of Medical Sciences & Research Center
ClinicalTrials.gov Identifier:
NCT01032863
First received: December 14, 2009
Last updated: March 23, 2010
Last verified: December 2009
History of Changes
  Purpose

Study hypothesis:- Benign joint hyper mobility syndrome which persists into adulthood is a special type of benign joint hyper mobility which is more likely to predispose to chronic musculoskeletal pain.

Young Indian adults aged between 25 and 40 years who are blood donors or relatives of patients admitted as inpatient or presenting to the out patient department, in Amrita Institute of Medical Sciences will be enrolled, after excluding the exclusionary criteria. They will be assessed for the presence of chronic musculoskeletal pain using a validated self filled questionnaire. The primary investigator who will be blinded to their response will examine them for the presence of Benign Joint Hyper mobility Syndrome and for tender points suggestive of fibromyalgia.

Primary Objective:- To determine whether chronic musculoskeletal pain is associated with Hypermobility among Indian adults.

Study design:- Cross sectional survey


Condition
Hypermobility, Joint
Arthralgia
Myofascial Pain Syndromes
Fibromyalgia
Pain Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Study of Association Between Hypermobility And Chronic MusculoSkeletal Pain:a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Amrita Institute of Medical Sciences & Research Center:

Primary Outcome Measures:
  • To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether hypermobility is associated with the presence of fibromyalgia in young Indian adults. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Determine the prevalence of hypermobility among Indian adults [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Determine prevalence of fibromyalgia in young Indian adults [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Determine the prevalence of chronic musculoskeletal pain among young indian adults [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Determine the association between American College of Rheumatology criteria for definition of Fibromyalgia and Simplified intensity scale questionnaire definition of Fibromyalgia. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Young healthy Indian adults
Persons aged between 25 and 40 years of age who are relatives of patients being treated in Amrita Institute of Medical Sciences (Inpatient or Outpatient) and voluntary blood donors at the same institute who are willing to participate in the study.

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Young Indian adults aged between 25 years and 40 years

Criteria

Inclusion Criteria:

  1. Completed their 25th birthday
  2. Not yet celebrated their 40th birthday
  3. Are relatives of patients being treated in Amrita Institute of Medical Sciences or voluntary blood donors in the same institute

Exclusion Criteria:

  1. Subjects who have been diagnosed previously with a inflammatory musculoskeletal disease.
  2. Subjects detected to have signs or symptoms of inflammatory arthritis on a detailed clinical examination and history taking.
  3. Subjects who have symptoms suggestive of diabetes mellitus or hypothyroidism or have been previously diagnosed with the same.
  4. Subjects who are not willing to participate.
  5. Subjects who have been diagnosed as having a connective tissue disorder or have a family history of the same.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032863

Locations
India
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682041
Sponsors and Collaborators
Amrita Institute of Medical Sciences & Research Center
Investigators
Principal Investigator: Sharath Kumar, MD Amrita Institute of Medical Sciences
Study Director: L Rajam, MD Amrita Institute of Medical Sciences
  More Information

Publications:

Responsible Party: Sharath Kumar, Amrita Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01032863     History of Changes
Other Study ID Numbers: K-PAE-09-258
Study First Received: December 14, 2009
Last Updated: March 23, 2010
Health Authority: India: Indian Council of Medical Research

Keywords provided by Amrita Institute of Medical Sciences & Research Center:
Chronic musculoskeletal pain
Benign joint hypermobility syndrome
Fibromyalgia

Additional relevant MeSH terms:
Arthralgia
Fibromyalgia
Myofascial Pain Syndromes
Joint Instability
Somatoform Disorders
Joint Diseases
Musculoskeletal Diseases
 Pain
Signs and Symptoms
Muscular Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013