NCT04084600

Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors

The Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors: a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of the State of Santa Catarina · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Kinesiotherapy Protocol	Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.
OTHER	Manual Therapy Protocol	Manual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues.
OTHER	Traditional Massage	Traditional Massage is a gentle and superficial massage.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-02-27
• Completion: 2020-02-27
• First posted: 2019-09-10
• Last updated: 2021-02-26

Locations

1 site across 1 country: Brazil