Hypermobility, JointHAMSNCT01032863
Association Between Hypermobility and Chronic Musculoskeletal Pain
An observational study of Hypermobility, Joint and Arthralgia, run by Amrita Institute of Medical Sciences & Research Center at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility, Joint, Arthralgia, Myofascial Pain Syndromes
- How many people
- 112 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young Indian adults aged between 25 years and 40 years
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
Primary Objective:- To determine whether chronic musculoskeletal pain is associated with Hypermobility among Indian adults.
Study design:- Cross sectional survey
- Keywords
- Chronic musculoskeletal pain, Benign joint hypermobility syndrome, Fibromyalgia
- Medical subject headings
- Joint Instability, Arthralgia, Myofascial Pain Syndromes, Fibromyalgia, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults
Measured: 3-6 months
Secondary outcomes (5)
Determine whether hypermobility is associated with the presence of fibromyalgia in young Indian adults.
Measured: 3-6 months
Determine the prevalence of hypermobility among Indian adults
Measured: 3-6 months
Determine prevalence of fibromyalgia in young Indian adults
Measured: 3-6 months
Determine the prevalence of chronic musculoskeletal pain among young indian adults
Measured: 3-6 months
Determine the association between American College of Rheumatology criteria for definition of Fibromyalgia and Simplified intensity scale questionnaire definition of Fibromyalgia.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypermobility, JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amrita Institute of Medical Sciences & Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Sharath Kumar, MD, Principal investigator, Amrita Institute of Medical SciencesL Rajam, MD, Study director, Amrita Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032863
- Sponsor's protocol ID
- K-PAE-09-258
- Acronym
- HAMS
- Status last verified
- Dec 2009
- First submitted
- 14 Dec 2009
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19465584Mikkelsson 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.
PubMed 8923376Engelbert 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.
PubMed 12612280Sendur 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.
PubMed 16636935
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Association Between Hypermobility And Chronic MusculoSkeletal Pain:a Pilot Study
- ClinicalTrials.gov ID
- NCT01032863
- Acronym / sponsor ID
- HAMS / K-PAE-09-258
- Keywords
- Chronic musculoskeletal pain, Benign joint hypermobility syndrome, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Amrita Institute of Medical Sciences & Research CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young Indian adults aged between 25 years and 40 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults
Time frame: 3-6 months
5 secondary outcomes
Determine whether hypermobility is associated with the presence of fibromyalgia in young Indian adults.
Time frame: 3-6 months
Determine the prevalence of hypermobility among Indian adults
Time frame: 3-6 months
Determine prevalence of fibromyalgia in young Indian adults
Time frame: 3-6 months
Determine the prevalence of chronic musculoskeletal pain among young indian adults
Time frame: 3-6 months
Determine the association between American College of Rheumatology criteria for definition of Fibromyalgia and Simplified intensity scale questionnaire definition of Fibromyalgia.
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Background: PubMed 19465584Leone 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.
- Background: PubMed 8923376Mikkelsson 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.
- Background: PubMed 12612280Engelbert 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.
- Background: PubMed 16636935Sendur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharath Kumar, MD principal investigator
Amrita Institute of Medical Sciences
L Rajam, MD study director
Amrita Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobility, Joint and Arthralgia, run by Amrita Institute of Medical Sciences & Research Center at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether chronic musculoskeletal pain is associated with hypermobility among young Indian adults (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032863, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2010.