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

Effect of a Specific Hand Intervention Program With Strength and Manipulative Dexterity Exercises in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06746376
Enrollment
32
Registered
2024-12-24
Start date
2025-04-01
Completion date
2025-11-01
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia

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

Interventions

OTHEROccupational Therapy

Description: Participants assigned to the intervention group will undergo a 8-week supervised hand exercise program designed to improve pain, manual dexterity, and functionality.

Sponsors

Universidad Europea de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluator will be blinded to the patient's allocation

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Brief Pain Inventory (BPI)Pre Intervention and after the 8 weeks interventionA 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

MeasureTime frameDescription
McCaffrey's Initial Pain Assessment ToolPre Intervention and after the 8 weeks interventionA 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 QuestionnairePre Intervention and after the 8 weeks interventionA 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.
DASH (Disabilities of the Arm, Shoulder, and Hand) QuestionnairePre Intervention and after the 8 weeks interventionA 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.
Box and Block TestPre Intervention and after the 8 weeks interventionA 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 TestPre Intervention and after the 8 weeks interventionA 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.
Purdue Pegboard TestPre Intervention and after the 8 weeks interventionA 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.

Countries

Spain

Contacts

Primary ContactVanesa Abuín-Porras, PhD
vanesa.abuin@universidadeuropea.es+34 676566073
Backup ContactNuria Muñoz-Bermúdez, PT
nuria.muñoz@universidadeuropea.es+34 676566073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026