Pes planus Musculoskeletal Diseases Flat foot [pes planus] (acquired)
Conditions
Interventions
Wearing arm
Participants will be selected from the Chief Investigator’s osteopathic patients. A trial case history will be taken to determine that they are eligible for the trial. Writ
Sponsors
Footjacks Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 8. Cancer 9. Pregnancy or planned pregnancy 10. Severe osteoarthritis of lower limb joints 11. Inflammatory arthritis 12. Recent or complicated fractures 13. Congenital lower limb deformity 14. Undertaking a course of medical treatment or physical therapy of more than 1 a month that could interfere with the validity of the trial data 15. Foot pathology which interferes with levelling of the pelvis 16. Already wearing standard arch supports 17. Progressive and/ or severe multiple sclerosis Measuring arm: 1. Musculoskeletal system is unable to adjust to changes in movement through the lower limb, pelvis and spine 2. Subjects being unlevel at the iliac crests of less than 1.5 degrees using the Palm Inclinometer 3. A congenital lower limb deformity 4. Any balance problem making difficult to stand on one leg 5. Anyone who is unable to follow the necessary instructions. They will not be excluded if they have a family member who can explain/translate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wearing arm: Level of pain and physical functioning as determined by the Oswestry Low Back Disability Questionnaire at baseline and at the end of 1, 2, 3, 5 and 7 months Measuring arm: Levelness or substantial levelness of the iliac crests with or without pelvic translation. Measurements will be taken on the three footbeds in easy normal standing with the feet pointing straight where the iliac crests are not otherwise level in bare feet in the same stance. The measurements will be compared to the position of the iliac crests when standing in the same stance with the centre of pressure on the lateral aspect of the calcanei. | — |
Secondary
| Measure | Time frame |
|---|---|
| Wearing arm: 1. Safety and adverse events. Subjects will be asked to report adverse events that are not expected at baseline and at the end of the 1, 2, 3, 5 and 7 months. Subjects will be asked to advise of unusual, unexpected or persistent adverse events as they occur so that appropriate action can be taken. 2. Usual pain in the last week, measured using a VAS assessment at inception and at the end of 1st, 2nd, 3rd, 5th and 7th months 3. Stability in high heel shoes (women only), measured using VAS assessment at inception, and at the end of 1st, 2nd, 3rd, 5th and 7th months 4. Comfort, measured using a VAS assessment at inception, and at the end of 1st, 2nd, 3rd, 5th and 7th months 5. Significant global improvement, measured using a VAS assessment at the end of 1st, 2nd, 3rd, 5th and 7th months 6. Function in the lower limb, measured using the Lower Extremity Functional Scale at the end of the 1st, 2nd, 3rd 5th and 7th months Measuring arm: 1. Levelness or substantial levelness of the ASIS’s in the coronal plane in the same stance as in 1.above with or without pelvic translation testing the three footbeds in easy normal bilateral standing and comparing the same to their levelness when standing in the same stance with the centre of pressure on the lateral calcanei 2. The rotational attitude of HAT (Head, Arms and Thorso) in the coronal plane as measured just below the xiphoid process standing on the most collapsing calcaneus in the transverse/coronal planes in unilateral stance and the foot placed straight at mid stance. The degree of rotation, whether left or right, should substantially approximate that as measured when standing on the same calcaneus at mid stance on a bare foot and standing with the foot on the ground and standing on the lateral aspect of the calcaneus, on a straight placed foot 3. Preven | — |
Countries
United Kingdom
Contacts
Public ContactMark Stern
Outcome results
None listed