An assessment by measurement (measuring arm) on the effects of a Footjacks flat orthotic compared to a flat insole and a standard orthotic on the lower limb, pelvis and spine together with the wearing effects (wearing arm) over a seven month period on adults with chronic low back pain compared to a flat control insole

Not Applicable

Completed

• Conditions: Pes planus; Musculoskeletal Diseases; Flat foot [pes planus] (acquired)

• Registration Number: ISRCTN37543220
• Lead Sponsor: Footjacks Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-23
• Study Completion: 2018-04-30
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 59

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Wearing arm:<br> 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<br><br> Measuring arm:<br> 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.<br>