Effect of a Specific Hand Intervention Program With Strength and Manipulative Dexterity Exercises in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluator will be blinded to the patient's allocation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: Pre Intervention and after the 8 weeks intervention
A validated tool used to assess the severity of pain and its impact on daily functioning. Participants will report pain intensity on a numeric scale and describe how pain interferes with their daily life activities.
次要结局
- DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire(Pre Intervention and after the 8 weeks intervention)
- McCaffrey's Initial Pain Assessment Tool(Pre Intervention and after the 8 weeks intervention)
- ABILHAND Questionnaire(Pre Intervention and after the 8 weeks intervention)
- Purdue Pegboard Test(Pre Intervention and after the 8 weeks intervention)
- Box and Block Test(Pre Intervention and after the 8 weeks intervention)
- Minnesota Rate of Manipulation Test(Pre Intervention and after the 8 weeks intervention)
研究者
Vanesa Abuín
Asistant Professor
Universidad Europea de Madrid