Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.

Not Applicable

Not yet recruiting

• Conditions: Arthralgia

• Registration Number: NCT06746376
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-04-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	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.

Secondary Outcome Measures

Name	Time	Method
DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire	Pre Intervention and after the 8 weeks intervention	A self-reported questionnaire that measures physical function and symptoms in individuals with upper limb conditions. It evaluates the ability to perform activities of daily living (ADLs) involving the hand, arm, and shoulder.
McCaffrey's Initial Pain Assessment Tool	Pre Intervention and after the 8 weeks intervention	A structured assessment that includes diagrams for marking pain locations, along with descriptions of pain quality, intensity, and duration. It helps to capture a comprehensive view of pain perception.
ABILHAND Questionnaire	Pre Intervention and after the 8 weeks intervention	A tool designed to assess manual ability and hand function in daily activities. Participants rate how easy or difficult it is to perform specific tasks requiring hand use.
Purdue Pegboard Test	Pre Intervention and after the 8 weeks intervention	A standardized test to measure fine motor skills, hand-eye coordination, and manual dexterity. Participants are tasked with placing small pegs into holes on a board as quickly as possible, following a specified pattern.
Box and Block Test	Pre Intervention and after the 8 weeks intervention	A test of gross manual dexterity where participants move small blocks from one compartment to another within a set time, assessing speed and motor function of the hand.
Minnesota Rate of Manipulation Test	Pre Intervention and after the 8 weeks intervention	A comprehensive assessment of fine and gross manual dexterity, involving tasks like placing, rotating, and moving objects with one or both hands. It measures speed, accuracy, and coordination in manipulative tasks.

Trial Locations

Locations (1)

Universidad Europea de Madrod; 🇪🇸 Villaviciosa De Odón, Spain