Effectiveness of Four Orthotic Insoles on Pain in the Lower Body Associated With Musculoskeletal Stress

Inclusion Criteria:

1. Those who gave informed consent.
2. Those who understood the purpose of the investigation, cooperate with theinvestigation procedures and tasks and were to attend the investigational site for allinvestigation assessments.
3. Those were willing to continue with their normal daily activities, including anycosmetic foot care regimens (including the use of products) throughout theinvestigation and not partake in exercise which is not normal for them and which wouldbe deemed by the Investigator to impact study assessments, or any new foot care orpodiatric treatments unless agreed in advance with the Investigator.
4. Those who wore the same or similar type of standard shoe during their workingday/shift for at least the 4 weeks prior to enrolment (Visit 1) (or they have worn adifferent shoe which cause no change to their pain) and who were able to wear the samestandard* shoe during their working day / shift for the duration of the investigation. Eligibility regarding this criterion was confirmed at Visit 1 but will also confirmedby the physiotherapist at Visit 2, following their assessment. *A standard shoe was defined as closed shoe, ≤2-inch heel, with an adequate sole,upper and toe box to accommodate the orthotic insole, as determined by thephysiotherapist. Shoes with orthotic-type internal contouring (as determined by thephysiotherapist to include features which could alter gait) or shoes with an archsupport greater than 12 mm would not be permitted. Odour-eaters cannot be used duringthe treatment period.
5. Male and female subjects from the age of 18 years and a BMI of 18.5-29.9 kg/m²inclusive.
6. Those who had access to a mobile device (iOS or Android smart phone or tablet), withaccess to the internet, and are able to operate an app.
7. Those with a shoe size between 4.5 to 11 (UK).
8. Those who worked at least 30 hours per week which usually involved "working episodes" (defined as at least 3 (up to 6) consecutive working days (of at least 6 hours each atwork) following at least 2 consecutive non-working days), which were expected tocontinue throughout their involvement in the investigation, and included at least 4working episodes during the 4 (up to 5)-week treatment period. These working episodes should be non-complex in the opinion of the Investigator, toensure continued eligibility.
9. Those who spent most (at least three quarters) of their working day on their feet, andremained in their current employment/work environment throughout the investigationperiod.
10. Those who have experienced pain associated with musculoskeletal stress during workingepisodes, for at least 4 weeks prior to enrolment (Visit 1) that they can distinguishas being in one of the following primary areas of pain or combination thereof, thatthe Investigator or designee considers could be treated with the relevant insole to beused in the investigation:

• Lower back
• Knee and/or Heel
• Arch
• Heel Eligibility regarding this criterion will also be confirmed by the physiotherapist atVisit 2, following their assessment.

11. Those who scored an average of 5 (±1) on the BPI average pain item (question 5) overthe first three consecutive working days of the run-in period working episode**, whenassessed specifically in their primary target pain area/pain area combination, asconfirmed at Visit 2.

• If the run-in period constituted more than one working episode (e.g. due to thescheduling of Visit 2), only the data from the first working episode was includedin the calculation to determine eligibility, providing this included at leastthree consecutive working days. Otherwise data from the second working episodewas used.

Exclusion Criteria:

1. Those who had a current medical condition that is contraindicated by the use of theorthotic insoles (e.g. peripheral vascular disease, sensory neuropathy or diabetes).
2. Those who currently use prescribed orthotics for biomechanical or other issues, orhave received and used prescribed orthotics within the last 12 months orover-the-counter (OTC) orthotics in the last 6 months (odour-eaters and anynon-structured/non-orthotic shock-absorber insole were permitted).
3. Those with any significant medical history which in the opinion of the Investigatorcould have interfered with the assessments of the investigation. For example;structural conditions (e.g. bunion or bunionette), lower limb or foot injury,rheumatic disease (e.g. rheumatoid arthritis, scleroderma, polymyalgia rheumatica),fibromyalgia, neurological disease or moderate to severe depression.
4. Those who were taking any of the following medications:
5. Anti-psychotic, sedatives, muscle-relaxants or medicines intended to treatneuropathic pain
6. Anti-inflammatory medications which would reduce systemic inflammation or locallyat the target pain areas (low dose Aspirin (75 mg daily) and nasal/inhaledsteroids could have been considered acceptable, where in the opinion of theInvestigator they would not interfere with the assessments of the investigation)
7. An unstable dose of anti-depressants (defined as a change in therapy within thelast 6 months).
8. Those who are taking regular medication for targeted pain (including OTC pain relief,in excess of 2g paracetamol daily) which is either beyond the maximum recommendeddaily dose according to the SmPC or which the Investigator deems inappropriate for thesubject to continue at the same dose throughout the investigation.
9. Those who were pregnant or who had given birth within the past 6 months.
10. Females of child-bearing potential who were unwilling to use a minimum of an "acceptable" (as defined by the Clinical Trials Facilitation Group (CFTG; 2014)recommendations) level of birth control, for the entire duration of the investigation. Suitable methods of birth control (in accordance with "highly effective" and "acceptable" methods of birth control defined by the CTFG) included:
11. Combined (estrogen and progestogen containing) hormonal contraception associatedwith the inhibition of ovulation; oral, intravaginal, transdermal.
12. Progestogen-only hormonal contraception associated with the inhibition ofovulation; oral, intravaginal, transdermal.
13. Progestogen-only oral hormonal contraception, where inhibition of ovulation isnot the primary mode of action
14. Male or female condom with or without spermicide
15. Cap, diaphragm or sponge with spermicide
16. Intrauterine device
17. Intrauterine hormone-releasing system
18. Bilateral tubal occlusion
19. Vasectomised partner (where this was the subject's sole sexual partner and wherethe vasectomised partner had received medical assessment of the surgical success)
20. Sexual abstinence (where the subject was willing to refrain from heterosexualintercourse during the entire period of the investigation in line with theirpreferred and usual lifestyle) Females who were considered to be of child-bearing potential were those who werefertile, following menarche and until becoming post-menopausal unless permanentlysterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomyand bilateral oophorectomy. A post-menopausal state is defined as no menses for 12months without an alternative medical cause (Clinical Trials Facilitation Group, 2014).
21. Those who suffered from allergies or sensitivities to the raw material of the insoles (as detailed in the Investigator Brochure).
22. Those who had participated in another clinical investigation within the 3 months priorto enrolment into the run-in period.
23. Employee at the investigational site, or a partner or first degree relative of theInvestigator or member of the investigation team at the site.
24. Those, in the opinion of the Investigator, who were not deemed suitable or were unableto comply fully with the investigation requirements, for any other reason.