Clinical trial NCT01032863: Association Between Hypermobility and Chronic Musculoskeletal Pain
Official title: A Study of Association Between Hypermobility And Chronic MusculoSkeletal Pain:a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypermobility, Joint
Arthralgia
Myofascial Pain Syndromes
Fibromyalgia
Pain Disorder
Keywords: Chronic musculoskeletal pain
Benign joint hypermobility syndrome
Fibromyalgia
Lead sponsor: Amrita Institute of Medical Sciences & Research Center
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 112
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young Indian adults aged between 25 years and 40 years

Brief 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


Eligibility 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.

Primary outcomes:
measure: To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults
timeFrame: 3-6 months
Secondary outcomes:
measure: Determine whether hypermobility is associated with the presence of fibromyalgia in young Indian adults.
timeFrame: 3-6 months
measure: Determine the prevalence of hypermobility among Indian adults
timeFrame: 3-6 months
measure: Determine prevalence of fibromyalgia in young Indian adults
timeFrame: 3-6 months
measure: Determine the prevalence of chronic musculoskeletal pain among young indian adults
timeFrame: 3-6 months
measure: Determine the association between American College of Rheumatology criteria for definition of Fibromyalgia and Simplified intensity scale questionnaire definition of Fibromyalgia.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences
state: Kerala
Study officials:
affiliation: Amrita Institute of Medical Sciences
name: Sharath Kumar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amrita Institute of Medical Sciences
name: L Rajam, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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. doi: 10.1007/s10067-006-0304-4. Epub 2006 Apr 25.