Breast Neoplasms Clinical Trial
Official title:
Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors
NCT number | NCT02825810 |
Other study ID # | UGR0116 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | May 2022 |
Verified date | May 2022 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - To be over 18 years old - Have passed a period equal o more 5 years since breast cancer diagnosis - Have diagnosis of stage I, II or IIIA breast cancer - Have signed informed consent - Have medical clearance for participation - Inability to get level 2 in the craniocervical flexion test Exclusion Criteria: - Have diagnosis of arthritis or fibromyalgia - Have cancer recurrence - Have been operated through previous surgery of cervical column - To be taking any treatment for pain or altered motor control during last 12 months |
Country | Name | City | State |
---|---|---|---|
Spain | University of Granada | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neck Disability Index (NDI) | It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items | Participants will be followed over 9 weeks | |
Secondary | Craniocervical Flexion Test (CCFT) | It is used to assess deficit of cervical motor pattern | Participants will be followed over 9 weeks | |
Secondary | Algometry | Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden) | Participants will be followed over 9 weeks | |
Secondary | Visual Analogue Scale (VAS) | It is used to assess subjective pain. It contains scores in the range of 0 to 10 (0 = 'no pain'; 10 = 'worst imaginable pain'). Participants will have to mark the level of pain that they feel in that moment for neck-shoulders areas | Participants will be followed over 9 weeks | |
Secondary | Scale for Mood Assessment | It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items | Participants will be followed over 9 weeks | |
Secondary | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 | It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures | Participants will be followed over 9 weeks | |
Secondary | European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) | It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing disease symptoms, side effects of treatment, body image, sexual functioning, and future perspective | Participants will be followed over 9 weeks | |
Secondary | Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) | It is used to calculate energy expenditure for leisure time physical activity | Participants will be followed over 9 weeks | |
Secondary | International Fitness Scale (IFIS) | It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility | Participants will be followed over 9 weeks |
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