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

NCT06746376 | Not Yet Recruiting

• 1 other identifier: HANDPROJECT001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthralgia

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI)

  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.

  Pre Intervention and after the 8 weeks intervention

Secondary Outcomes (6)

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

  Pre Intervention and after the 8 weeks intervention

• McCaffrey's Initial Pain Assessment Tool

  Pre Intervention and after the 8 weeks intervention

• ABILHAND Questionnaire

  Pre Intervention and after the 8 weeks intervention

• Purdue Pegboard Test

  Pre Intervention and after the 8 weeks intervention

• Box and Block Test

  Pre Intervention and after the 8 weeks intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Occupational Therapy

Control

NO INTERVENTION

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea de Madrod

Villaviciosa de Odón, Spain

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Vanesa Abuín-Porras, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanesa Abuín-Porras, PhD

CONTACT

+34 676566073; vanesa.abuin@universidadeuropea.es

Nuria Muñoz-Bermúdez, PT

CONTACT

+34 676566073; nuria.muñoz@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blinded to the patient's allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)