Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Occupational Therapy.
- Who it may be relevant to
- Registry conditions: Arthralgia. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Specific Hand Intervention Program With Strength and Manipulative Dexterity Exercises in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.
Overview
This study aims to evaluate the impact of a 12-week hand exercise program on pain, manual dexterity, and hand function in women experiencing hand joint pain (arthralgia) due to hormone therapy after breast cancer. Participants will be randomly assigned to either an intervention group, where they will perform specific hand exercises, or a control group, which will not receive any exercise program. Pain levels, hand function, and manual dexterity will be assessed before and after the intervention using questionnaires and functional tests. The goal is to determine whether targeted hand exercises can improve pain and daily hand use in this population.
Detailed description
This is a randomized, evaluator-blinded clinical trial that aims to determine the effects of a 12-week hand exercise program on pain, manual dexterity, and functional performance in women experiencing hand arthralgia due to hormone therapy following breast cancer. Participants will be randomly assigned to one of two groups: an intervention group performing specific hand exercises or a control group with no exercise intervention.
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
Interventions
- Other 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.
Primary outcome measures
- Brief Pain Inventory (BPI) [Time frame: Pre Intervention and after the 8 weeks intervention]
Secondary outcome measures (6)
- DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire [Time frame: Pre Intervention and after the 8 weeks intervention]
- McCaffrey's Initial Pain Assessment Tool [Time frame: Pre Intervention and after the 8 weeks intervention]
- ABILHAND Questionnaire [Time frame: Pre Intervention and after the 8 weeks intervention]
- Purdue Pegboard Test [Time frame: Pre Intervention and after the 8 weeks intervention]
- Box and Block Test [Time frame: Pre Intervention and after the 8 weeks intervention]
- Minnesota Rate of Manipulation Test [Time frame: Pre Intervention and after the 8 weeks intervention]
Eligibility criteria
Inclusion criteria
Experiencing hand arthralgia as a result of hormone therapy (aromatase inhibitors or tamoxifen) following breast cancer.
Ability to communicate pain levels effectively. Ability to follow simple instructions to participate in the intervention and assessments.
Exclusion Criteria Participants requiring any medication changes during the study period that could influence pain levels (increase or decrease).
Concurrent physiotherapy or occupational therapy specifically targeting the hand during the study.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Universidad Europea de Madrod — Villaviciosa de Odón
Identifiers
NCT: NCT06746376 · HANDPROJECT001