Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire | 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. | Pre Intervention and after the 8 weeks intervention |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanesa AbuĂn-Porras, PhD | Contact | +34 676566073 | vanesa.abuin@universidadeuropea.es | |
| Nuria Muñoz-Bermúdez, PT | Contact | +34 676566073 | nuria.muñoz@universidadeuropea.es |
| Name | Affiliation | Role |
|---|---|---|
| Vanesa AbuĂn-Porras, PhD | Universidad Europea de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrod | Villaviciosa de OdĂłn | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
The evaluator will be blinded to the patient's allocation
| McCaffrey's Initial Pain Assessment Tool | 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. | Pre Intervention and after the 8 weeks intervention |
| ABILHAND Questionnaire | 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. | Pre Intervention and after the 8 weeks intervention |
| Purdue Pegboard Test | 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. | Pre Intervention and after the 8 weeks intervention |
| Box and Block Test | 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. | Pre Intervention and after the 8 weeks intervention |
| Minnesota Rate of Manipulation Test | 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. | Pre Intervention and after the 8 weeks intervention |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |