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

NCT04746755 | Terminated

• 1 other identifier: NPD85302
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (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.

  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)

• 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

• 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

• 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.

• 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.

Other Outcomes (32)

• Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress during the first three days of the break-in working episode. As assessed by the change in BPI questionnaire. (For each of the four orthotic insoles)

  Average pain on Days 0-3 compared to Days 7-10 for subjects that worked three consecutive working days, Average pain on Days 0-5 compared to Days 9-14 for subjects that worked five consecutive working days

• Evaluation of the pain relief caused by orthotic insoles on pain associated with musculoskeletal stress during the break-in working episode. As assessed by the change in the BPI score. (For each of the four orthotic insoles separately)

  Average pain on Days 3 was compared that on Day 10 for subjects that worked three consecutive working days, Average pain on Days 5 compared to Day 14 for subjects that worked five consecutive working days.

• Change in quality of life, associated with improvement pain as assessed by the Brief Pain Inventory questionnaire following the break-in period (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 five CWD or Day 3 compared to Day 12-15, Day 17-20, Day 22-25, Day 27-30 for subjects that worked 3 CWD

Study Arms (4)

Experimental: Lower back pain associated with musculoskeletal stress

EXPERIMENTAL

Subjects 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.

Device: Orthotic Insole: Lower Back

Experimental: Heel pain associated with musculoskeletal stress

EXPERIMENTAL

Subjects 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.

Device: Orthotic Insole: Heel

Experimental: Knee to Heel pain associated with musculoskeletal stress

EXPERIMENTAL

Subjects 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.

Device: Orthotic Insole: Knee to Heel

Experimental: Arch pain associated with musculoskeletal stress

EXPERIMENTAL

Subjects 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.

Device: Orthotic Insole: Arch

Interventions

Orthotic Insole: Lower Back DEVICE

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.

Experimental: Lower back pain associated with musculoskeletal stress

Orthotic Insole: Heel DEVICE

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

Experimental: Heel pain associated with musculoskeletal stress

Orthotic Insole: Knee to Heel DEVICE

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.

Experimental: Knee to Heel pain associated with musculoskeletal stress

Orthotic Insole: Arch DEVICE

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.

Experimental: Arch pain associated with musculoskeletal stress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"
• (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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• SynteractHCR Deutschland GmbH: collaborator

Study Sites (1)

CPS Research

Glasgow, Scotland, G20 0XA, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 27231116 BACKGROUND

• 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.

  PMID: 24335153 BACKGROUND

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

  PMID: 2965809 BACKGROUND

• 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.

  PMID: 27919918 BACKGROUND

• 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.

  PMID: 11690728 BACKGROUND

• 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.

  PMID: 28229556 BACKGROUND

• 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.

  PMID: 10146874 BACKGROUND

• 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.

  PMID: 15668775 BACKGROUND

• 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.

  PMID: 11734607 BACKGROUND

• 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.

  PMID: 27067913 BACKGROUND

• 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.

  PMID: 26355119 BACKGROUND

• 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.

  PMID: 25041875 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gordon Crawford, BSc (Hons), MBChB

  Gordon.crawford@cpsresearch.co.uk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label, single-centre, parallel-group clinical investigation

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 10, 2021
• Study Start: June 21, 2019
• Primary Completion: December 16, 2019
• Study Completion: March 5, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)