Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.
NCT ID: NCT06746376
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2025-04-01
2025-11-01
Brief Summary
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Detailed Description
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The primary outcome will be changes in hand pain levels assessed using the Brief Pain Inventory (BPI) and McCaffrey's Initial Pain Assessment Tool. Secondary outcomes will include functional performance measured with the DASH and ABILHAND questionnaires, as well as manual dexterity, speed, and coordination assessed through standardized tests (Purdue Pegboard Test, Box and Block Test, and Minnesota Rate of Manipulation Test).
The study will evaluate the potential benefits of targeted hand exercises for improving pain, dexterity, and quality of life in breast cancer survivors experiencing treatment-related hand symptoms.
Detailed Description
Study Design:
Type: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-Blind (Evaluator) Primary Purpose: Treatment Duration: 12 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
Description:
Participants assigned to the intervention group will undergo a 8-week supervised hand exercise program designed to improve pain, manual dexterity, and functionality. Sessions will last 45 minutes and occur once per week under the supervision of a qualified occupational therapist and one self-administrated home exercise session. The program includes three structured phases per session
Warm-Up Phase (10 minutes)
Gentle hand and wrist stretches Main Exercise Phase (25 minutes)
This phase focuses on strengthening, manual dexterity, and functional tasks:
Strengthening Exercises
Manual Dexterity Exercises
Functional Tasks (Simulated Activities of Daily Living - AVDs):
Cool-Down Phase (10 minutes)
8 weeks, with 45-minute sessions twice weekly.
Occupational Therapy
Description:
Participants assigned to the intervention group will undergo a 8-week supervised hand exercise program designed to improve pain, manual dexterity, and functionality.
Control
Description:
Participants in the control group will not receive any intervention during the study period. They will undergo the same assessments as the intervention group at baseline and after 8 weeks to evaluate changes over time.
Details:
The control group will serve as a comparison to determine the effects of time alone on pain, manual dexterity, and hand functionality in women with hormone therapy-related arthralgia.
Participants will continue their usual daily activities and standard care during the study period.
No specific exercises or additional therapies will be provided as part of the study.
No interventions assigned to this group
Interventions
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Occupational Therapy
Description:
Participants assigned to the intervention group will undergo a 8-week supervised hand exercise program designed to improve pain, manual dexterity, and functionality.
Eligibility Criteria
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Inclusion Criteria
Ability to communicate pain levels effectively. Ability to follow simple instructions to participate in the intervention and assessments.
Exclusion Criteria
Pre-existing diagnosis of arthritis or osteoarthritis in the hand before starting hormone therapy.
Presence of systemic diseases associated with hand arthralgia. Neurological conditions affecting hand movement.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Universidad Europea de Madrid
OTHER
Responsible Party
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Vanesa Abuín
Asistant Professor
Principal Investigators
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Vanesa Abuín-Porras, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Europea de Madrid
Locations
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Universidad Europea de Madrod
Villaviciosa de Odón, , Spain
Countries
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Central Contacts
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Facility Contacts
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Vanesa Abuín-Porras
Role: primary
Other Identifiers
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HANDPROJECT001
Identifier Type: -
Identifier Source: org_study_id