Clinical trial NCT04084600: Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors
Official title: The Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to verify whether manual therapy associated with kinesiotherapy is more effective than kinesiotherapy alone in the treatment of chronic pain and upper limb dysfunction in women surviving cancer of mama. It is a randomized controlled double blind clinical trial (evaluator and patient), parallel in two groups (Intervention Group and Sham Group). The intervention will last 6 weeks and chronic pain and upper limb functionality will be evaluated. 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. Manual therapy associated with kinesiotherapy is expected to yield superior results to the isolated kinesiotherapy in chronic pain and upper limb functionality.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in Chronic Pain Intensity
timeFrame: Change from Pre Intervention Chronic Pain Intensity at 6 weeks Post Intervention
measure: Change in Pain Location
timeFrame: Change from Pre Intervention Pain Location at 6 weeks Post Intervention
measure: Change in Neuropathic Pain
timeFrame: Change from Pre Intervention neuropathic pain at 6 weeks Post Intervention
measure: Change in central sensitization pain
timeFrame: Change from Pre Intervention central sensitization pain at 6 weeks Post Intervention
measure: Change in pain dimensions
timeFrame: Change from Pre Intervention pain dimensions at 6 weeks Post Intervention
Secondary outcomes:
measure: Upper limb functionality
timeFrame: Change from Pre Intervention Upper limb functionality at 6 weeks Post Intervention
measure: Muscle strength
timeFrame: Change from Pre Intervention Muscle strength at 6 weeks Post Intervention
measure: Range of motion
timeFrame: Change from Pre Intervention Range of motion at 6 weeks Post Intervention
measure: Circumference of the arm
timeFrame: Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Santa Catarina State University
state: Santa Catarina
Study officials:
affiliation: Universidade do Estado de Santa Catarina this account disabled
name: Gilmar M Santos, PhD
role: STUDY_CHAIR
References: