Association Between Hypermobility and Chronic Musculoskeletal Pain

Fibromyalgia Clinical Trial

— HAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032863
• Other study ID #: K-PAE-09-258
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: March 23, 2010
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: December 2009
• Source: Amrita Institute of Medical Sciences & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 40 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthralgia
• Fibromyalgia
• Hypermobility, Joint
• Musculoskeletal Pain
• Myofascial Pain Syndromes
• Pain Disorder

Locations

Country	Name	City	State
India	Amrita Institute of Medical Sciences	Kochi	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Amrita Institute of Medical Sciences & Research Center

Country where clinical trial is conducted

India, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults		3-6 months	No
Secondary	Determine whether hypermobility is associated with the presence of fibromyalgia in young Indian adults.		3-6 months	No
Secondary	Determine the prevalence of hypermobility among Indian adults		3-6 months	No
Secondary	Determine prevalence of fibromyalgia in young Indian adults		3-6 months	No
Secondary	Determine the prevalence of chronic musculoskeletal pain among young indian adults		3-6 months	No
Secondary	Determine the association between American College of Rheumatology criteria for definition of Fibromyalgia and Simplified intensity scale questionnaire definition of Fibromyalgia.		3-6 months	No