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

European University

Status: Not yet enrolling

Conditions: Arthralgia

Treatments: Other: Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06746376

HANDPROJECT001

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Occupational Therapy

Control

No Intervention group

Description:

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.