An assessment of the effects Footjack flat orthotic on (1) the foot, lower limbs, pelvis, and spine compared to a control and a standard arch support and (2) on pain and function in subjects with pes planus and chronic low back pain over a 7 month period compared to a control with random allocation

Footjacks Limited0 sites59 target enrollmentAugust 23, 2017

Overview

No summary available.

Registry

who.int

Start Date

August 23, 2017

End Date

April 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Footjacks Limited

•Wearing arm:
•1\. Age 18\-75
•2\. Iliac crests not level with easy normal standing with feet straight and iliac crests level or substantially level when standing on lateral calcanei
•3\. Chronic low back pain (three episodes of back pain in the last 24 months with pain at the time consent taken) below T12, including lumbar spine and pelvic joints with or without radiating pain
•Measuring arm:
•1\. Age 18 to 75
•2\. Iliac crests not level by at least 1\.5 degrees with easy normal standing with feet straight and iliac crests level or substantially level when standing on the lateral calcanei

•Wearing arm:
•1\. Under 18 and over 75
•2\. No history of chronic low back pain
•3\. Lack of suitability for whatever clinical reason to be randomised (any condition in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in the study)
•4\. Person unable to give consent
•5\. Vulnerable people
•6\. Patient with any musculoskeletal condition making it difficult for the spine to adapt to a change, e.g. spinal fusion in the neck, disc herniation threatening the cord, severe spinal stenosis etc. Subject will complete a case history at the assessment stage of the trial and excluded if unsuitable for the trial due to such a condition
•7\. Severe sciatica with neurological signs
•9\. Pregnancy or planned pregnancy
•10\. Severe osteoarthritis of lower limb joints