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

This was an open-label, single-centre, parallel-group clinical investigation, to evaluate the effectiveness and in-use tolerability of a range of four orthotic insoles on target areas of pain in the lower body, associated with musculoskeletal stress, experienced by those who spend most of their working day on their feet

This was an open-label, single-centre, parallel-group clinical investigation, to evaluate the effectiveness and in-use tolerability of a range of four orthotic insoles on target areas of pain in the lower body, associated with musculoskeletal stress, experienced by those who spend most of their working day on their feet.

The investigation design included two periods; 'run-in' period and 'treatment' period. The treatment period comprised of two sub-periods; a 'breaking-in' period and the 'full use' period. The breaking-in period was intended to allow time for the subjects' feet to accustom to wearing the insoles. The full-use period was used to determine effectiveness of the insoles. These periods constitute lengths of time defined for the purpose of the investigation as "working episodes". Working episodes were defined as at least 3 (up to 6) consecutive working days of at least 6 hours each at work, following at least 2 consecutive non-working days.

Eligible subjects at Visit 1 (screening) were enrolled into the run-in period, where subjects were assessed prior to treatment with the insoles under investigation. During the run-in period, consisting of one working episode, subjects self-reported their pain without using insoles on a daily basis (Q3-9 of the Brief Pain Inventory (BPI)), in order to provide the baseline data to which the insoles were compared. Eligible subjects were enrolled into the treatment period at Visit 2 and assigned the insole relevant to the target pain area/pain area combination. Insole use was built up gradually during a breaking-in period, which constituted one working episode, with at least one nonworking day prior to the start of the working episode. Following the breaking-in period, the full-use period commenced. During the treatment period, subjects wore the insoles on working days and as much as possible on non-working days, self-reporting their pain daily (BPI Questions 3 - 9 inclusive).

Eligibility Criteria:
Inclusion Criteria:

1. Those who gave informed consent.
2. Those who understood the purpose of the investigation, cooperate with the investigation procedures and tasks and were to attend the investigational site for all investigation assessments.
3. Those were willing to continue with their normal daily activities, including any cosmetic foot care regimens (including the use of products) throughout the investigation and not partake in exercise which is not normal for them and which would be deemed by the Investigator to impact study assessments, or any new foot care or podiatric treatments unless agreed in advance with the Investigator.
4. Those who wore the same or similar type of standard shoe during their working day/shift for at least the 4 weeks prior to enrolment (Visit 1) (or they have worn a different shoe which cause no change to their pain) and who were able to wear the same standard\* shoe during their working day / shift for the duration of the investigation.

   Eligibility regarding this criterion was confirmed at Visit 1 but will also confirmed by 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 the physiotherapist. Shoes with orthotic-type internal contouring (as determined by the physiotherapist to include features which could alter gait) or shoes with an arch support greater than 12 mm would not be permitted. Odour-eaters cannot be used during the treatment period.
5. Male and female subjects from the age of 18 years and a BMI of 18.5-29.9 kg/m² inclusive.
6. Those who had access to a mobile device (iOS or Android smart phone or tablet), with access 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 at work) following at least 2 consecutive non-working days), which were expected to continue throughout their involvement in the investigation, and included at least 4 working episodes during the 4 (up to 5)-week treatment period.

   These working episodes should be non-complex in the opinion of the Investigator, to ensure continued eligibility.
9. Those who spent most (at least three quarters) of their working day on their feet, and remained in their current employment/work environment throughout the investigation period.
10. Those who have experienced pain associated with musculoskeletal stress during working episodes, for at least 4 weeks prior to enrolment (Visit 1) that they can distinguish as being in one of the following primary areas of pain or combination thereof, that the Investigator or designee considers could be treated with the relevant insole to be used in the investigation:

    * Lower back
    * Knee and/or Heel
    * Arch
    * Heel

    Eligibility regarding this criterion will also be confirmed by the physiotherapist at Visit 2, following their assessment.
11. Those who scored an average of 5 (±1) on the BPI average pain item (question 5) over the first three consecutive working days of the run-in period working episode\*\*, when assessed specifically in their primary target pain area/pain area combination, as confirmed at Visit 2.

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

Exclusion Criteria:

1. Those who had a current medical condition that is contraindicated by the use of the orthotic insoles (e.g. peripheral vascular disease, sensory neuropathy or diabetes).
2. Those who currently use prescribed orthotics for biomechanical or other issues, or have received and used prescribed orthotics within the last 12 months or over-the-counter (OTC) orthotics in the last 6 months (odour-eaters and any non-structured/non-orthotic shock-absorber insole were permitted).
3. Those with any significant medical history which in the opinion of the Investigator could 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:

   1. Anti-psychotic, sedatives, muscle-relaxants or medicines intended to treat neuropathic pain
   2. Anti-inflammatory medications which would reduce systemic inflammation or locally at the target pain areas (low dose Aspirin (75 mg daily) and nasal/inhaled steroids could have been considered acceptable, where in the opinion of the Investigator they would not interfere with the assessments of the investigation)
   3. An unstable dose of anti-depressants (defined as a change in therapy within the last 6 months).
5. 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 recommended daily dose according to the SmPC or which the Investigator deems inappropriate for the subject to continue at the same dose throughout the investigation.
6. Those who were pregnant or who had given birth within the past 6 months.
7. 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:
   1. Combined (estrogen and progestogen containing) hormonal contraception associated with the inhibition of ovulation; oral, intravaginal, transdermal.
   2. Progestogen-only hormonal contraception associated with the inhibition of ovulation; oral, intravaginal, transdermal.
   3. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
   4. Male or female condom with or without spermicide
   5. Cap, diaphragm or sponge with spermicide
   6. Intrauterine device
   7. Intrauterine hormone-releasing system
   8. Bilateral tubal occlusion
   9. Vasectomised partner (where this was the subject's sole sexual partner and where the vasectomised partner had received medical assessment of the surgical success)
   10. Sexual abstinence (where the subject was willing to refrain from heterosexual intercourse during the entire period of the investigation in line with their preferred and usual lifestyle)

   Females who were considered to be of child-bearing potential were those who were fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause (Clinical Trials Facilitation Group, 2014).
8. Those who suffered from allergies or sensitivities to the raw material of the insoles (as detailed in the Investigator Brochure).
9. Those who had participated in another clinical investigation within the 3 months prior to enrolment into the run-in period.
10. Employee at the investigational site, or a partner or first degree relative of the Investigator or member of the investigation team at the site.
11. Those, in the opinion of the Investigator, who were not deemed suitable or were unable to comply fully with the investigation requirements, for any other reason.