Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors
Keywords
Abstract
Description
This study will be a double-blind randomized controlled trial, parallel in two groups (intervention group and sham). Participants will initially be evaluated by a trained investigator who will be blinded and assigned randomly (random numbers generated on the computer) block for the intervention and sham groups by an opaque envelope draw. Participants will be randomized into two groups: intervention and sham. Both groups will undergo a kinesiotherapy program once a week for 6 consecutive weeks.
Also, participants in the intervention group will receive, once a week, a manual therapy protocol, while participants in the Sham group will receive traditional massage. When making the invitation to participate in the survey, individuals will not be required to participate if they do not agree, and therefore will not be penalized. Participants who agree to participate in the survey will sign a Free and Informed Consent Form and will be informed of the possibility of withdrawing from the survey at any stage, without penalty. The collection of the evaluation and intervention will be carried out in a salon Clinic School of Physiotherapy in the Center of Health and Sports Sciences (CEFID) of the State University of Santa Catarina (UDESC) in the city of Florianópolis- SC. All personal identification data of the participants will be preserved according to resolution of the national health council, taking into account the possibility of scientific dissemination of the results obtained. The risks of these procedures will be medium, since the participant may present muscle pain after the intervention protocol. To minimize these risks will be available, if necessary, attendance at the Clinic School of Physiotherapy. The sample will be selected in a non-probabilistic way for convenience. This study will include women diagnosed with breast cancer who have undergone breast surgery with curative intent and who have completed chemotherapy and / or radiotherapy treatments.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 09/02/2019 |
| Estimated Enrollment Submitted: | 09/08/2019 |
| First Posted: | 09/09/2019 |
| Last Update Submitted: | 03/25/2020 |
| Last Update Posted: | 03/29/2020 |
| Actual Study Start Date: | 10/31/2019 |
| Estimated Primary Completion Date: | 09/29/2020 |
| Estimated Study Completion Date: | 11/29/2020 |
Condition or disease
Intervention/treatment
Other: Kinesiotherapy Protocol
Other: Intervention Group
Other: Sham Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Intervention Group Once a week for 6 consecutive weeks, this group will receive a manual therapy protocol with an approach based on Taylor et al., 1990; Schleip et al., 2012; Bienfait, 1999 and Myers, 2016, lasting 20 minutes, focused on the upper quadrant homolateral to the surgery. Shortly thereafter, this group will participate in a kinesiotherapy protocol with stretching, mobility and strengthening exercises, also for 20 minutes. All sessions will be individual. | Other: Intervention Group Manual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues. |
| Sham Comparator: Sham Group Once a week for 6 consecutive weeks, this group will receive a soft and shallow traditional massage, lasting 20 minutes. Shortly thereafter, this group will participate to the same kinesiotherapy protocol with stretching, mobility and strengthening exercises, also for 20 minutes. All sessions will be individual. | Other: Sham Group Traditional Massage is a gentle and superficial massage. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - age over 18 years; - have had surgery to treat breast cancer;- have completed chemotherapy and / or radiotherapy; - have upper quadrant pain homolateral to surgery for at least the last 3 months, with a score of 4 or more on the visual analog scale (VAS) in the last week - present a score greater than or equal to 30 on the Arm, Shoulder, and Hand Dysfunction Questionnaire (DASH). Exclusion Criteria: - difficulty in understanding the Portuguese language to answer the questionnaires; - have had bilateral surgery to treat breast cancer; - be in palliative care; - pregnant women; - be using analgesic and / or anti-inflammatory drugs - women with rheumatic diseases - be in physical therapy during the intervention period. |
Outcome
Primary Outcome Measures
1. Change in Chronic Pain Intensity [Change from Pre Intervention Chronic Pain Intensity at 6 weeks Post Intervention]
2. Change in Pain Location [Change from Pre Intervention Pain Location at 6 weeks Post Intervention]
3. Change in Neuropathic Pain [Change from Pre Intervention neuropathic pain at 6 weeks Post Intervention]
4. Change in central sensitization pain [Change from Pre Intervention central sensitization pain at 6 weeks Post Intervention]
5. Change in pain dimensions [Change from Pre Intervention pain dimensions at 6 weeks Post Intervention]
Secondary Outcome Measures
1. Upper limb functionality [Change from Pre Intervention Upper limb functionality at 6 weeks Post Intervention]
2. Muscle strength [Change from Pre Intervention Muscle strength at 6 weeks Post Intervention]
3. Range of motion [Change from Pre Intervention Range of motion at 6 weeks Post Intervention]
4. Circumference of the arm [Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention]
