Clinical trial NCT06746376: Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthralgia
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Pre Intervention and after the 8 weeks intervention
Secondary outcomes:
measure: DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire
timeFrame: Pre Intervention and after the 8 weeks intervention
measure: McCaffrey's Initial Pain Assessment Tool
timeFrame: Pre Intervention and after the 8 weeks intervention
measure: ABILHAND Questionnaire
timeFrame: Pre Intervention and after the 8 weeks intervention
measure: Purdue Pegboard Test
timeFrame: Pre Intervention and after the 8 weeks intervention
measure: Box and Block Test
timeFrame: Pre Intervention and after the 8 weeks intervention
measure: Minnesota Rate of Manipulation Test
timeFrame: Pre Intervention and after the 8 weeks intervention
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Universidad Europea de Madrod
Study officials:
affiliation: Universidad Europea de Madrid
name: Vanesa Abuín-Porras, PhD
role: PRINCIPAL_INVESTIGATOR
References: