Association Between Hypermobility and Chronic Musculoskeletal Pain

NCT ID: NCT01032863

Last Updated: 2010-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypermobility, Joint Arthralgia Myofascial Pain Syndromes Fibromyalgia Pain Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amrita Institute of Medical Sciences & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Amrita Institute of Medical Sciences

Principal Investigators

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Sharath Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Amrita Institute of Medical Sciences

L Rajam, MD

Role: STUDY_DIRECTOR

Amrita Institute of Medical Sciences

Locations

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Amrita Institute of Medical Sciences

Kochi, Kerala, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 19465584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8923376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12612280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16636935 (View on PubMed)

Other Identifiers

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K-PAE-09-258

Identifier Type: -

Identifier Source: org_study_id

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