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Musculoskeletal PainNCT04746755

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

A study testing Orthotic Insole: Lower Back, Orthotic Insole: Heel and Orthotic Insole: Knee to Heel in people with Musculoskeletal Pain, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Pain
What is being tested?
Orthotic Insole: Lower Back, Orthotic Insole: Heel and Orthotic Insole: Knee to Heel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteUnited Kingdom
Study dates
21 Jun 2019to 5 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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"
  • (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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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)
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  • 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.
  • Suitable methods of birth control (in accordance with "highly effective" and "acceptable" methods of birth control defined by the CTFG) included:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with the inhibition of ovulation; oral, intravaginal, transdermal.
  • Progestogen-only hormonal contraception associated with the inhibition of ovulation; oral, intravaginal, transdermal.
  • Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
  • Male or female condom with or without spermicide
  • Cap, diaphragm or sponge with spermicide
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Vasectomised partner (where this was the subject's sole sexual partner and where the vasectomised partner had received medical assessment of the surgical success)
  • 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).
  • Those who suffered from allergies or sensitivities to the raw material of the insoles (as detailed in the Investigator Brochure).
  • Those who had participated in another clinical investigation within the 3 months prior to enrolment into the run-in period.
  • Employee at the investigational site, or a partner or first degree relative of the Investigator or member of the investigation team at the site.
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • CPS Research

    Glasgow, Scotland, G20 0XA

Other trials in United Kingdom

About this study

Official title: 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

Read the 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).

Being tested
Orthotic Insole: Lower Back, Orthotic Insole: Heel, Orthotic Insole: Knee to Heel, Orthotic Insole: Arch
Medical subject headings
Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthotic Insole: Lower BackDevice

    This Insole is a full-length shaped orthotic insole, with a heel cup and an arch support. The insole can cover several shoe sizes and can be cut to the correct size to fit in the shoe.

  • Orthotic Insole: HeelDevice

    This Insole is a horseshoe shaped flexible heel cup with a softer area where the heel would be expected.

  • Orthotic Insole: Knee to HeelDevice

    This Insole is a ¾ length rigid orthotic insole with a softer area where the heel would be expected. Each insole will cover several shoe sizes.

  • Orthotic Insole: ArchDevice

    This Insole is a ¾ length shaped medical device with a softer area incorporated into the ball of foot and heel area and an external arch.

    support and 6-8 mm metatarsal dome. The slim fit insole runs from the heel along under the arch of the foot and reaches to just behind the toes to prevent squashing the toes in tight fitting shoes.

Study groups in NCT04746755
Study groupRoleWhat they receive
Experimental: Lower back pain associated with musculoskeletal stressExperimentalSubjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced lower back pain; the subjects selection was corroborated by a physiotherapist.
Receives: Device: Orthotic Insole: Lower Back
Experimental: Heel pain associated with musculoskeletal stressExperimentalSubjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced pain in the heels of their feet; the subjects selection was corroborated by a physiotherapist.
Receives: Device: Orthotic Insole: Heel
Experimental: Knee to Heel pain associated with musculoskeletal stressExperimentalSubjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced Knee to Heel pain; the subjects selection was corroborated by a physiotherapist.
Receives: Device: Orthotic Insole: Knee to Heel
Experimental: Arch pain associated with musculoskeletal stressExperimentalSubjects eligible for the study self selected the insole for the pain in-accordance with the pain that they were experiencing due to musculoskeletal stress. Subjects within this arm of the study experienced pain in the arch of their feet; the subjects selection was corroborated by a physiotherapist.
Receives: Device: Orthotic Insole: Arch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    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.

    Measured: Time frame is dependent on working pattern Days 0-5 compared to Days 44-47 and Days 0-3 compared to Days 27-30

Secondary outcomes (11)

  1. 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)

    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), during the first three consecutive working days of each working episode (WE) of the treatment period

    The baseline WE was defined as the first three consecutive working days of (Days 0-3):

    1. st WE- the first three days could occur from Days 12-15 for subjects that worked 3 consecutive working days up to Days 23-26 for subjects that worked five consecutive working days
    2. nd WE- the first three days could occur from Days 17-20 for subjects that worked 3 consecutive working days up to Days 30-33 for subjects that worked five consecutive working days
    3. rd WE- the first three days could occur from Days 22-25 for subjects that worked 3 consecutive working days up to Days 37-40 for subjects that worked five consecutive working days

    Measured: 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

  2. 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)

    The change from baseline in the composite score of the worse, 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), completed at the end of each working episode (WE) of the treatment period.

    The baseline WE was defined as Days 0-3 or Days 0-5 depending on the working pattern of the subjects:

    1. st WE- the last working day could occur on Day 12-15 for subjects that worked 3 consecutive working days (CWD) up to Days 23-28 for subjects that worked 5 CWD
    2. nd WE- the last working day could occur on Day 17-20 for subjects that worked 3 CWD up to Day 30-35 for subjects that worked 5 CWD
    3. rd WE- the last working day of the 3rd working episode could occur from Day 22-25 for subjects that worked 3 CWD up to Day 37-42 for subjects that worked 5 CWD
    4. th WE- the last working day could occur from Day 27-30 for subjects that worked 3 CWD up to Day 44-49 for subjects that worked 5 CWD

    Measured: 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

  3. 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.)

    The overall proportion of subjects who achieve a change of ≥1 unit 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), during the first three consecutive working days of the last working episode of the treatment period. For each of the four orthotic insoles separately.

    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 .

    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

    Measured: 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

  4. Subject impression of change in pain (Visual Analogue Scale) (For each of the four orthotic insoles separately.)

    Subjects' rating of overall improvement in pain since pre-treatment, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately.

    Scored on a scale of -3 to +3 with 0 indicating no change in pain, a positive number indicating an improvement and negative indicating an increase in the pain

    Measured: Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern.

  5. Investigator impression of change in subjects' pain (Visual Analogue Scale) (For each of the four orthotic insoles separately.)

    Investigator's rating of the subjects' overall improvement in pain since pre-treatment, completed following the end of the last working episode of the treatment period. For each of the four orthotic insoles separately.

    Scored on a scale of -3 to +3 with 0 indicating no change in pain, a positive number indicating an improvement and negative indicating an increase in the pain

    Measured: Day 6 and Day 15 (Visit 1) compared to Day 31 and Day 50 depending on the subjects working pattern.

  6. 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.)

    The change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the Brief Pain Inventory pain (BPI) interference scores (Question 9; composite (average) score), completed at the end of each working episode (WE) of the treatment period.

    The baseline WE was defined as Day 3 or Days 5 depending on the working pattern:

    1. st WE- occurred from Day 12-15 for subjects that worked 3 consecutive working days (CWD) up to Day 23-28 for subjects that worked 5 CWD
    2. nd working episode- occurred from Day 17-20 for subjects that worked 3 CWD up to Day 30-35 for subjects that worked 5 CDW
    3. rd working episode- occurred from Day 22-25 for subjects that worked 3 CWD up to Day 37-42 for subjects that worked five consecutive working days
    4. th working episode- occurred from Day 27-30 for subjects that worked 3 CWD up to Day 44-49 for subjects that worked 5 CWD The BPI question is a scale of 0-10 with the lower number indicating less pain

    Measured: 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

  7. 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.)

    Change from baseline in quality of life, associated with overall improvement in pain in the primary area of pain, assessed by the EQ-5D-5L, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately.

    The baseline was defined as the first three up to five consecutive working days of baseline working episode therefore in the context of this endpoint the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. Compared to the responses at the end of last working episode which could occur from Day 30 for subjects that worked 3 consecutive working days up to Day 49 for subjects that worked five consecutive working days.

    The EuroQol-5 dimension-5 Level (EQ-5D-5L), is made up of 5 questions scored 1 to 5 from these questions an index is created with a range between zero and 1 with a zero being death and 1 being perfect quality of life.

    Measured: 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

  8. 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.)

    Change from baseline in work productivity and activity, assessed by the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), completed at the end of last working episode of the treatment period. For each of the four orthotic insoles separately.

    The baseline was defined as the first 3 up to 5 consecutive working days (CWD) of baseline working episode therefore in the context of this endpoint the baseline assessment would occur on Day 3 or Days 5 depending on the working pattern of the subjects. Compared to the responses at the end of last working episode which could occur from Day 30 for subjects that worked 3 CWD up to Day 49 for subjects that worked 5 CWD.

    The WPAI:SHP six questions on the subjects productivity and activity Impairment. Questions comprised of information on employment, including hours at work, hours missed from work and reasons for work missed. As well as the effect that pain had on their daily activities.

    Measured: 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

  9. Subject impression of change in their work productivity and activity. (Visual Analogue Scale) (For each of the four orthotic insoles separately.)

    Subjects' rating of overall improvement in their quality of life and work productivity and activity since pre-treatment, completed at the end of the last working episode of the treatment period. For each of the four orthotic insoles separately.

    The last working day is therefore different for each subjects working pattern this could occur from Day 30 for subjects that worked 3 consecutive working days (CWD) up to Day 49 for subjects that worked 5 CWD.

    This assessment was scored on a scale of -3 to +3 with 0 indicating no change, a positive number indicating an improvement and negative indicating an increase in quality of life

    Measured: 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

  10. Investigator impression of change in quality of life (Visual Analogue Scale) (For each of the four orthotic insoles separately.)

    Investigator's rating of the subjects' overall improvement in their quality of life since pre-treatment, following the end of the last working episode of the treatment period. For each of the four orthotic insoles separately.

    The last working day is therefore different for each subjects working pattern this could occur from Day 30 for subjects that worked 3 consecutive working days up to Day 49 for subjects that worked five consecutive working days.

    This assessment was scored on a scale of -3 to +3 with 0 indicating no change in quality of life, a positive number indicating an improvement and negative indicating an increase in quality of life

    Measured: 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

  11. Safety and tolerability of the device (For each of the four orthotic insoles separately.)

    Overall proportion of subjects with AEs and adverse device effects (ADEs), i.e. the occurrence of one or more AEs/ADEs per subject. For each of the four orthotic insoles separately.

    Measured: through to study completion, from point of informed consent (Day 1) up to Visit 3 (Day 50)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start21 Jun 2019
  3. Primary completion16 Dec 2019
  4. Study completion5 Mar 2020

Why it stopped: Participants experienced data collection issues when using the eDiary, these issues increased the burden and lowered compliance. Updates to the eDiary were unsuccessful at resolving the issues so the decision was taken to terminate the Investigation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
An open-label, single-centre, parallel-group clinical investigation
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04746755
Sponsor's protocol ID
NPD85302
Status last verified
Feb 2021
First submitted
29 Jan 2021
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Almeida JS, Vanderlei FM, Pastre EC, Martins RA, Padovani CR, Filho GC. Comparison of Two Types of Insoles on Musculoskeletal Symptoms and Plantar Pressure Distribution in a Work Environment: A Randomized Clinical Trial. Clin Med Res. 2016 Jun;14(2):67-74. doi: 10.3121/cmr.2016.1301. Epub 2016 May 26.

    PubMed 27231116

  • Amer AO, Jarl GM, Hermansson LN. The effect of insoles on foot pain and daily activities. Prosthet Orthot Int. 2014 Dec;38(6):474-80. doi: 10.1177/0309364613512369. Epub 2013 Dec 13.

    PubMed 24335153

  • Basford JR, Smith MA. Shoe insoles in the workplace. Orthopedics. 1988 Feb;11(2):285-8. doi: 10.3928/0147-7447-19880201-08.

    PubMed 2965809

  • Bonanno DR, Landorf KB, Munteanu SE, Murley GS, Menz HB. Effectiveness of foot orthoses and shock-absorbing insoles for the prevention of injury: a systematic review and meta-analysis. Br J Sports Med. 2017 Jan;51(2):86-96. doi: 10.1136/bjsports-2016-096671. Epub 2016 Dec 5.

    PubMed 27919918

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PubMed 11690728

  • Gill TK, Menz HB, Landorf KB, Arnold JB, Taylor AW, Hill CL. Identification of Clusters of Foot Pain Location in a Community Sample. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1903-1908. doi: 10.1002/acr.23212. Epub 2017 Nov 14.

    PubMed 28229556

  • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.

    PubMed 10146874

  • Shabat S, Gefen T, Nyska M, Folman Y, Gepstein R. The effect of insoles on the incidence and severity of low back pain among workers whose job involves long-distance walking. Eur Spine J. 2005 Aug;14(6):546-50. doi: 10.1007/s00586-004-0824-z. Epub 2005 Jan 25.

    PubMed 15668775

  • Sobel E, Levitz SJ, Caselli MA, Christos PJ, Rosenblum J. The effect of customized insoles on the reduction of postwork discomfort. J Am Podiatr Med Assoc. 2001 Nov-Dec;91(10):515-20. doi: 10.7547/87507315-91-10-515.

    PubMed 11734607

  • Stanhope J. Brief Pain Inventory review. Occup Med (Lond). 2016 Aug;66(6):496-7. doi: 10.1093/occmed/kqw041. Epub 2016 Apr 11. No abstract available.

    PubMed 27067913

  • Stolt M, Suhonen R, Virolainen P, Leino-Kilpi H. Lower extremity musculoskeletal disorders in nurses: A narrative literature review. Scand J Public Health. 2016 Feb;44(1):106-15. doi: 10.1177/1403494815602989. Epub 2015 Sep 9.

    PubMed 26355119

  • Waters TR, Dick RB. Evidence of health risks associated with prolonged standing at work and intervention effectiveness. Rehabil Nurs. 2015 May-Jun;40(3):148-65. doi: 10.1002/rnj.166. Epub 2014 Jul 7.

    PubMed 25041875

Questions about this trial

What is this clinical trial studying?

A study testing Orthotic Insole: Lower Back, Orthotic Insole: Heel and Orthotic Insole: Knee to Heel in people with Musculoskeletal Pain, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Participants experienced data collection issues when using the eDiary, these issues increased the burden and lowered compliance. Updates to the eDiary were unsuccessful at resolving the issues so the decision was taken to terminate the Investigation.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04746755, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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