Association Between Hypermobility and Chronic Musculoskeletal Pain (HAMS)

A Study of Association Between Hypermobility And Chronic MusculoSkeletal Pain:a Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Arthralgia; Fibromyalgia; Myofascial Pain Syndromes; Hypermobility, Joint; Pain Disorder

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• India
  • Kerala
    • Kochi, Kerala, India, 682041
      • Amrita Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young Indian adults aged between 25 years and 40 years

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults	3-6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine whether hypermobility is associated with the presence of fibromyalgia in young Indian adults.	3-6 months
Determine the prevalence of hypermobility among Indian adults	3-6 months
Determine prevalence of fibromyalgia in young Indian adults	3-6 months
Determine the prevalence of chronic musculoskeletal pain among young indian adults	3-6 months
Determine the association between American College of Rheumatology criteria for definition of Fibromyalgia and Simplified intensity scale questionnaire definition of Fibromyalgia.	3-6 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Leone V, Tornese G, Zerial M, Locatelli C, Ciambra R, Bensa M, Pocecco M. Joint hypermobility and its relationship to musculoskeletal pain in schoolchildren: a cross-sectional study. Arch Dis Child. 2009 Aug;94(8):627-32. doi: 10.1136/adc.2008.150839. Epub 2009 May 12.
• Mikkelsson M, Salminen JJ, Kautiainen H. Joint hypermobility is not a contributing factor to musculoskeletal pain in pre-adolescents. J Rheumatol. 1996 Nov;23(11):1963-7.
• Engelbert RH, Bank RA, Sakkers RJ, Helders PJ, Beemer FA, Uiterwaal CS. Pediatric generalized joint hypermobility with and without musculoskeletal complaints: a localized or systemic disorder? Pediatrics. 2003 Mar;111(3):e248-54. doi: 10.1542/peds.111.3.e248.
• Sendur OF, Gurer G, Bozbas GT. The frequency of hypermobility and its relationship with clinical findings of fibromyalgia patients. Clin Rheumatol. 2007 Apr;26(4):485-7. doi: 10.1007/s10067-006-0304-4. Epub 2006 Apr 25.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 23, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Fibromyalgia; Chronic musculoskeletal pain; Benign joint hypermobility syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Arthralgia; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Musculoskeletal Pain; Joint Instability
• Other Study ID Numbers: K-PAE-09-258