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Menopausal hand study

Clinical Trial for menopausal hand with low-heat generating warm pad on hands. - Menopausal hand study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052250171
Enrollment
20
Registered
2025-12-19
Start date
2026-02-19
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

hand symptoms in perimenopause menopausal hand, hand symptoms in perimenopause, hand stiffness, finger joint pain, moring stiffness

Interventions

After a 2-week of observation period, participants are requested to wear the holders whith sposable warmers inserted on their bilateral hands during sleeping (warmer adapted on dorsal side of the wris

Sponsors

Shima Yoshihito
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women between 40 and 59 years old. 2. Persons who are aware of "swelling" or "stiffness" in both hands, or who have pain in two or more finger joints. 3. Persons who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Persons whose blood CRP exceeds 0.2 mg/dL within 1 month 2. Persons with positive serum anti-CCP antibody within 6 months 3. Persons with positive serum antinuclear antibody within 6 months 4. Persons who meet the criteria for classification of the following autoimmune diseases or have a history of such diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic scleroderma, Sjogren's syndrome, idiopathic inflammatory muscle disease, ankylosing spondylitis, psoriatic arthritis) 5. Persons who have skin diseases at the site of wearing the warmer 6. Persons with peripheral neuropathy of upper extremities or past medical history of that (e.g., cervical spondylosis, diabetic neuropathy, carpal tunnel syndrome, etc.) 7. Persons unable to remove/wear the warmers by themselves 8. Persons who are judged ineligible by the investigators for other reasons.

Design outcomes

Primary

MeasureTime frame
The change in the average Morning stiffness severity recorded in the participants' diary between the warmer-applied period and non-warmer-applied period. MS severity is defined the 0-10 numerical scale for the intensity of morning stiffness on his/her hands assessed by a participant himself/herself.

Secondary

MeasureTime frame
1.Visual Analogue Scale (VAS: 0-100 mm) for hand joint pain during the day 2. VAS for degree of disturbance by menopausal hand symptoms to daytime work 3. grip strength on waking 4. evaluation of upper limb function by questionnaire (HAND20) 5. adverse events

Contacts

Public ContactAkane Watanabe

The University of Osaka Hospital

a.watanabe@imed3.med.osaka-u.ac.jp+81-6-6879-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026