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NCT Number: NCT06746376

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

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.

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Key information

Conditions

Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrod

Villaviciosa de Odón, Spain

Location contact

Vanesa Abuín-Porras

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occupational Therapy

Other

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 outcomes

  1. Brief Pain Inventory (BPI)

    Time frame: 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 outcomes

  1. DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire

    Time frame: 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.

  2. McCaffrey's Initial Pain Assessment Tool

    Time frame: 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.

  3. ABILHAND Questionnaire

    Time frame: 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.

  4. Purdue Pegboard Test

    Time frame: 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.

  5. Box and Block Test

    Time frame: 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.

  6. Minnesota Rate of Manipulation Test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nuria Muñoz-Bermúdez, PT

CONTACT

nuria.muñ[email protected]

+34 676566073

Vanesa Abuín-Porras, PhD

CONTACT

[email protected]

+34 676566073

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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