Comparing Foot-Type-Matched and Neutral Insoles for Foot Discomfort in Factory Workers
NCT07920523, Not applicable, Completed, Universidad San Jorge
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparing Foot-Type-Matched and Neutral Insoles for Foot Discomfort in Factory Workers | ClinicalTrials.gov |
| NCT number | NCT07920523 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 149 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universidad San Jorge | ClinicalTrials.gov |
| Conditions | Musculoskeletal Discomfort, Foot Discomfort | ClinicalTrials.gov |
| Interventions | Foot-type-matched prefabricated insole, Neutral prefabricated insole | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Bilateral Foot Discomfort Score (Cornell Musculoskeletal Discomfort Questionnaire) | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Sum of the right-foot and left-foot regional scores of the CMDQ (range 0 to 180). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. Compared between groups as the follow-up score adjusted for the baseline score. The approved protocol specified CMDQ musculoskeletal discomfort as the primary variable without defining a body region; the bilateral foot definition was established in the trial report after data collection. | ClinicalTrials.gov |
| Secondary | Complete CMDQ Total Score | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Sum of the regional scores of all 20 CMDQ body regions (range 0 to 1800). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. The approved protocol specified CMDQ musculoskeletal discomfort without defining a body region or score; this complete total is the closest operationalization. In the trial report it was analyzed as an exploratory secondary outcome without adjustment for multiplicity. | ClinicalTrials.gov |
| Secondary | Right-Foot CMDQ Score | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Right-foot regional score of the CMDQ (range 0 to 90). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. Defined in the trial report after data collection; analyzed as an exploratory secondary outcome without adjustment for multiplicity. | ClinicalTrials.gov |
| Secondary | Left-Foot CMDQ Score | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Left-foot regional score of the CMDQ (range 0 to 90). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. Defined in the trial report after data collection; analyzed as an exploratory secondary outcome without adjustment for multiplicity. | ClinicalTrials.gov |
| Secondary | Lower-Limb CMDQ Score | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Sum of the hip/buttocks, thigh, knee, lower leg and foot regional scores of the CMDQ (9 regions; range 0 to 810). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. Defined in the trial report after data collection; analyzed as an exploratory secondary outcome without adjustment for multiplicity. | ClinicalTrials.gov |
| Secondary | Axial/Spine CMDQ Score | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Sum of the neck, upper back and lower back regional scores of the CMDQ (3 regions; range 0 to 270). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. Defined in the trial report after data collection; analyzed as an exploratory secondary outcome without adjustment for multiplicity. | ClinicalTrials.gov |
| Secondary | CMDQ Score Excluding Upper-Limb Regions | Baseline (planned at insole delivery) and follow-up (planned 3 months after insole delivery; observed median interval between questionnaires 57 days, range 44 to 103 days) | Sum of the neck, upper back, lower back, hip/buttocks, thigh, knee, lower leg and foot regional scores of the CMDQ (12 regions; range 0 to 1080). Each CMDQ regional score is the product of frequency (0, 1.5, 3.5, 5 or 10), severity (1 to 3) and interference with work (1 to 3), range 0 to 90 per region; higher scores indicate more discomfort. CMDQ: Cornell Musculoskeletal Discomfort Questionnaire, Spanish version, previous working week. Defined in the trial report after data collection; analyzed as an exploratory secondary outcome without adjustment for multiplicity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)