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

NCT ID: NCT04084600

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-02-27

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Kinesiotherapy Protocol

Intervention Type: OTHER

Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.

Manual Therapy Protocol

Intervention Type: OTHER

Manual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues.

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.

Group Type: SHAM_COMPARATOR

Kinesiotherapy Protocol

Intervention Type: OTHER

Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.

Traditional Massage

Intervention Type: OTHER

Traditional Massage is a gentle and superficial massage.

Interventions

Kinesiotherapy Protocol

Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.

Intervention Type: OTHER

Manual Therapy Protocol

Manual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues.

Intervention Type: OTHER

Traditional Massage

Traditional Massage is a gentle and superficial massage.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of the State of Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Gilmar Moraes Santos, PT

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilmar M Santos, PhD

Role: STUDY_CHAIR

Universidade do Estado de Santa Catarina this account disabled

Locations

Santa Catarina State University

Florianópolis, Santa Catarina, Brazil

Countries

Brazil

Other Identifiers

Manual Therapy BCS

Identifier Type: -

Identifier Source: org_study_id