Association Between Hypermobility and Chronic Musculoskeletal Pain

NCT01032863 | Completed DMC

• 1 other identifier: K-PAE-09-258
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Hypermobility, Joint; Arthralgia; Myofascial Pain Syndromes; Fibromyalgia; Pain Disorder

Keywords

Chronic musculoskeletal pain; Benign joint hypermobility syndrome; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults

  3-6 months

Secondary Outcomes (5)

• 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

Study Arms (1)

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 Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young Indian adults aged between 25 years and 40 years

You may qualify if:

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

You may not qualify if:

• Subjects who have been diagnosed previously with a inflammatory musculoskeletal disease.
• Subjects detected to have signs or symptoms of inflammatory arthritis on a detailed clinical examination and history taking.
• Subjects who have symptoms suggestive of diabetes mellitus or hypothyroidism or have been previously diagnosed with the same.
• Subjects who are not willing to participate.
• Subjects who have been diagnosed as having a connective tissue disorder or have a family history of the same.

Sponsors & Collaborators

• Amrita Institute of Medical Sciences & Research Center: lead

Study Sites (1)

Amrita Institute of Medical Sciences

Kochi, Kerala, 682041, India

Location

Related Publications (4)

• 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.

  PMID: 19465584 BACKGROUND

• 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.

  PMID: 8923376 BACKGROUND

• 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.

  PMID: 12612280 BACKGROUND

• 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.

  PMID: 16636935 BACKGROUND

MeSH Terms

Conditions

Joint Instability; Arthralgia; Myofascial Pain Syndromes; Fibromyalgia; Somatoform Disorders

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders

Study Officials

• Sharath Kumar, MD

  Amrita Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• L Rajam, MD

  Amrita Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 24, 2010

Record last verified: 2009-12

Locations

IN (1)