Study on the effects of footwear on pain and fatigue in the lower extremities

Randomised controlled trial of health shoes with pillow concept technology to reduce pain and fatigue in the lower extremities

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10672939

Enrollment

140

Registered

2025-02-01

Start date

2025-02-14

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower extremity pain and fatigue Musculoskeletal Diseases

Interventions

Group 1 (Intervention): Shoes with Pillow Concept Technology, designed to reduce vibrations during walking to alleviate discomfort, pain, and fatigue in the lower extremities. The intervention period

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged between 25-60 years. 2. Pain or fatigue in the feet or lower extremities lasting more than one month. 3. Able to walk independently without assistance.

Exclusion criteria

Exclusion criteria: 1. History of foot or lower limb surgery within the past 6 months. 2. Neurological disorders affecting walking ability. 3. Use of medications that influence pain perception.

Design outcomes

Primary

Measure	Time frame
1. Foot health is measured using the Foot Health Assessment Questionnaire at baseline, 2-week follow-up, and 4-week follow-up 2. Pain intensity is measured using the Numerical Rating Scale (NRS) at baseline, 2-week follow-up, and 4-week follow-up 3. Pressure pain threshold is measured using a dolorimeter at baseline, 2-week follow-up, and 4-week follow-up 4. Balance is measured using the Single Leg Stance Test at baseline, 2-week follow-up, and 4-week follow-up 5. Functional reach is measured using the Functional Reach Test at baseline, 2-week follow-up, and 4-week follow-up	—

Measure

Time frame

1. Foot health is measured using the Foot Health Assessment Questionnaire at baseline, 2-week follow-up, and 4-week follow-up 2. Pain intensity is measured using the Numerical Rating Scale (NRS) at baseline, 2-week follow-up, and 4-week follow-up 3. Pressure pain threshold is measured using a dolorimeter at baseline, 2-week follow-up, and 4-week follow-up 4. Balance is measured using the Single Leg Stance Test at baseline, 2-week follow-up, and 4-week follow-up 5. Functional reach is measured using the Functional Reach Test at baseline, 2-week follow-up, and 4-week follow-up

—

Secondary

Measure	Time frame
User satisfaction for shoes will be assessed using Likert scale at 4 weeks	—

Countries

Indonesia

Contacts

Public ContactLaily Rahmawati

lailyrahmawati@uny.ac.id+62 813-3316-0801

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026