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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Musculoskeletal Pain
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress. Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire score. (For each of the four orthotic insoles separately.)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Those who gave informed consent.
- •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.
- •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.
- •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.
- •Male and female subjects from the age of 18 years and a BMI of 18.5-29.9 kg/m² inclusive.
- •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.
- •Those with a shoe size between 4.5 to 11 (UK).
- •Those who worked at least 30 hours per week which usually involved "working episodes"
Exclusion Criteria
- •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).
- •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).
- •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.
- •Those who were taking any of the following medications:
- •Anti-psychotic, sedatives, muscle-relaxants or medicines intended to treat neuropathic pain
- •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)
- •An unstable dose of anti-depressants (defined as a change in therapy within the last 6 months).
- •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.
- •Those who were pregnant or who had given birth within the past 6 months.
- •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.
Outcomes
Primary Outcomes
Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress. Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire score. (For each of the four orthotic insoles separately.)
Time Frame: Time frame is dependent on working pattern Days 0-5 compared to Days 44-47 and Days 0-3 compared to Days 27-30
The average change from baseline in the daily composite score of the worst, least, average and current pain, as measured by Questions 3-6 of the Brief Pain Inventory (BPI, scored on a scale of 0-10 with the lower number indicating less pain) when compared to the first three days of the last working episode. To account for differences in subjects working patterns a definition was created, a valid working episode was considered to be two non-working days followed by at least three and up to five working days. (this definition was used for all outcomes) The baseline was defined as the first three consecutive working days of baseline working episode (Days 0-3). The first three days of the last working episode could occur from Days 27-30 for subjects that worked 3 consecutive working days up to Days 44-47 for subjects that worked five consecutive working days For each of the four orthotic insoles separately.
Secondary Outcomes
- Subject impression of change in pain (Visual Analogue Scale) (For each of the four orthotic insoles separately.)(Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern.)
- Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress over the first three days of each working episode. Assessed though change in pain, measured by the BPI. (For each of the four orthotic insoles)(Days 0-5 compared to Days 23-26, Days 30-33, Days 37-40, Days 0-3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 consecutive working days)
- Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress over each working episode. Assessed though change in pain, measured by the BPI questionnaire.(For each of the four orthotic insoles)(Days 0-5 compared to Day 23-28, Day 30-35, Day 37-42, Day 44-49 for subjects that worked five consecutive working days, Days 0-3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 consecutive working days)
- Investigator impression of change in subjects' pain (Visual Analogue Scale) (For each of the four orthotic insoles separately.)(Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern.)
- Change in quality of life, associated with improvement pain as assessed by the Brief Pain Inventory questionnaire. (For each of the four orthotic insoles separately.)(Day 5 compared to Day 23-28, Day 30-35, Days 37-42 Day 44-49 for subjects that worked 5 CWD or Day 3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 CWD)
- Proportion of subjects who achieve a change of ≥1 unit from baseline Assessed though the change in pain, measured by the Brief Pain Inventory questionnaire score. (For each of the four orthotic insoles separately.)(Days 0-5 compared to Days 44-47 for subjects that worked 5 consecutive working days, Days 0-3 compared to Days 27-30 for subjects that worked 3 consecutive working days)
- Change in work productivity and activity as assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (For each of the four orthotic insoles separately.)(Quality of life on Day 3 up to 5 compared to Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days)
- Safety and tolerability of the device (For each of the four orthotic insoles separately.)(through to study completion, from point of informed consent (Day 1) up to Visit 3 (Day 50))
- Change in quality of life, associated with improvement in pain as assessed by the EQ-5D-5L (questionaire) (For each of the four orthotic insoles separately.)(Day 3 up to 5 compared to Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days)
- Investigator impression of change in quality of life (Visual Analogue Scale) (For each of the four orthotic insoles separately.)(Quality of life improvement assessed on Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days)
- Subject impression of change in their work productivity and activity. (Visual Analogue Scale) (For each of the four orthotic insoles separately.)(Quality of life improvement assessed on Day 49 for subjects that worked five consecutive working days or Day 30 for subjects that worked 3 consecutive working days)