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FLEXI recruitment information

This page provides some more detail on the inclusion and exclusion criteria, trial governance, and routes for referring patients into the FLEXI trial.

Trial Steering Committee

Trial Management Group

Trial Registration

National Research Register Number                  N0436130614
ISRCTN                                                                  85595438
Main site LREC (Leeds)                                       03/077
Other LREC - Bradford                                         03/09/388

STUDY AIMS

  Primary aim

·        To investigate the effects of FFOs on the lower limb symptoms associated with hypermobility syndrome (HMS).

 Secondary aims

·        To investigate the effects of FFOs on the health related quality of life of patients with lower limb symptoms associated with HMS.

·        To evaluate the effects of functional foot orthotic therapy on the joint kinematics and plantar pressure and force distributions of patients with HMS.

·        To describe the kinematics and plantar pressure and force distributions of patients with HMS, and to compare these data with those of an existing normative database.

Recruitment schedule

Recruitment will occur between January and November 2004. The  total study duration is projected to be  24 months, with individual patients involved for 12 months.

Inclusion criteria

Patients being recruited onto the trial will:
• Be aged 18 years or more
• Be able to understand the implications of the trial program and give informed consent
• Be willing to return for post-intervention follow up
• Have a clinical diagnosis of joint hypermobility based on the 1998 “Brighton criteria”
• Be suffering current musculoskeletal pain, discomfort or functional limitation in the lower extremity
• Have a hypermobile foot posture identified as potentially contributing to the symptomatology. (Foot hypermobility will be defined by a Foot Posture Index score [54, 55] of greater than five points)
• Have completed the run-in period and been entered into the randomisation protocol
 

 Exclusion criteria

• A history of major trauma to either leg/foot (single incident trauma resulting in manifest residual deformity or permanent impairment to, or loss of function)
• A history or spontaneous or surgical arthrodesis to the joints of the leg or foot
• A history of spontaneous dislocations of the hip, knee or ankle (note: isolated patella subluxation will not constitute knee dislocation)
• A history of any lower extremity surgery within the past twelve months (other than simple skin surgery eg for wart or naevus removal)
• Continuous foot pain due primarily to OA or other intractable causes ††.
• Any clinical presentation which would contra-indicate the prescription of functional foot orthoses
• Unwillingness or other inability to wear foot orthoses, caused by external factors such as footwear or other environmental considerations.
• Inability to understand verbal communication in English sufficient to give adequate informed consent.

 † Patients with a clinical diagnosis of Ehlers-Danlos syndrome (normally excluded by the Brighton criteria for diagnosis of benign familial HMS) will be eligible for entry onto the trial providing they satisfy the remainder of the physical Brighton criteria components. Any diagnosis of EDS will be noted on the CRF for later sub group analysis.
†† Based on X-ray confirmation provided by HAB or other consultant rheumatologist as appropriate.

Revised Brighton (1998) Criteria for the diagnosis of Benign Joint Hypermobility Syndrome.

BJHS is diagnosed in the presence of 2 major criteria, or one major and 2 minor criteria, or 4 minor criteria. Two minor criteria will suffice where there is an unequivocally affected first-degree relative. BJHS is excluded by presence of Marfan or or Ehlers-Danlos syndrome (other than EDS type III).

 Major criteria 

1. A Beighton score of 4/9 or greater (either currently or historically)
2. Arthralgia for longer than 3 months in 4 or more joints

Minor criteria

1. A Beighton score of 1,2 or 3/9 (0,1,2,or 3 if aged 50+)
2. Arthralgia (≥ 3 mo) in 1-3 joints, or back pain ((≥ 3 mo), spondylosis, spondylolysis/ spondylolisthesis.
3. Dislocation/subluxation in more than one joint or in one joint on more than one occasion.
4. Soft tissue rheumatism ≥ 3 lesions (e.g. epicondylitis, tenosynovitis, bursitis)
5. Marfanoid habitus (tall, slim, span: height ratio >1.3, upper: lower segment ratio <0.89, arachnodactyly  [+Steinberg/ wrist signs])
6. Abnormal skin: striae, hyperextensibility, thin skin, papyraceous scarring
7. Eye signs: drooping eyelids or myopia or anti mongoloid slant
8. Varicose veins or hernia or uterine/rectal prolapse

Previous and concomitant treatment

Patients already wearing foot orthoses as part of a current treatment regimen are eligible to enter the study on completion the same one-month run-in period (in this instance a wash-out period) as participants naive to foot-orthoses.
During the course of the study, treatment involving non-trial foot orthoses will be prohibited.

With the exception of foot orthoses, patients enrolled in the study will be permitted to receive other forms of conservative medical, physical and podiatric therapies as would be provided normally in the course of their day-to-day clinical management.

Referral of potential patients

Referrals are followed up immediately by the study team, with a telephone call to the potential recruit to establish eligibility.

Referrers need provide only the patient's name, date of birth, address, telephone number and, if possible, a preferred time for us to call the patient.

These can be provided by email to:

h.davys@leeds.ac.uk or a.redmond@leeds.ac.uk

Or via telephone to 0113 343 4938 (24hr voicemail is available on the number)

Send mail to a.redmond@leeds.ac.uk with questions or comments about this web site.
Last modified: March 24, 2003