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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Kinesiotherapy Protocol; Other: Manual Therapy Protocol; Other: Traditional Massage

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88080350
      • Santa Catarina State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.
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: Kinesiotherapy Protocol; Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.; Other: Traditional Massage; Traditional Massage is a gentle and superficial massage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chronic Pain Intensity	Chronic pain intensity will be evaluated through the analogue visual scale. It consists of a numbered line from 1 to 10, 0 being no pain and 10 the worst pain imaginable.	Change from Pre Intervention Chronic Pain Intensity at 6 weeks Post Intervention
Change in Pain Location	Pain location will be assessed using a Body Pain Diagram. It is a graphical representation of a woman's body in anterior, posterior, and lateral views to identify the location and frequency of pain. In this diagram, women should mark with a X their main pain points in the upper quadrant homolateral to the surgery.	Change from Pre Intervention Pain Location at 6 weeks Post Intervention
Change in Neuropathic Pain	Neuropathic Pain will be assessed using the Douler Neuropathique 4 Questionnaire. It aims to discriminate neuropathic pain from nociceptive pain. It consists of 10 items grouped into 4 sections. The first 7 items are related to pain quality (burning, painful cold, and electric shock) and its association with abnormal sensations (tingling, numbness, and itching). The remaining 3 items are associated with neurological examination in the painful area (touch hypoesthesia, needle stick hypoesthesia, and tactile allodynia). Each positive item receives a 1-point score and the total score is calculated as the sum of all 10 items. A score of 4 or higher indicates the diagnosis of neuropathic pain.	Change from Pre Intervention neuropathic pain at 6 weeks Post Intervention
Change in central sensitization pain	Central sensitization pain will be assessed using the the Central Sensitization Questionnaire. It aims to evaluate the symptoms considered associated with central sensitization pain. The total score ranges from 0 to 100 and a score of 40 or more indicates the presence of central sensitization pain.	Change from Pre Intervention central sensitization pain at 6 weeks Post Intervention
Change in pain dimensions	Pain dimensions will be assessed using the McGill Pain Questionnaire. It is an instrument that assesses pain dimensions in physical (sensitive and discriminative) aspects, pain interpretation (affective and motivational) and pain understanding (cognitive and evaluative). It is made up of 4 large groups, divided into 20 smaller groups of words, each of which is related to a type of pain. The groups are numbered according to intensity, with 1 being the smallest: 10 groups of 42 words related to physical aspects; 5 groups of 14 words related to the affective part; 1 group of 5 words about pain in general; 4 groups of 17 words that did not fit the other groups, called miscellaneous. The values are summed and the result is given by the pain index (sum of the intensity values of the chosen descriptors, with a maximum value of 78) and by the number of descriptors (how many words were marked, with a maximum value of 20).	Change from Pre Intervention pain dimensions at 6 weeks Post Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb functionality	The Arm, Shoulder and Hand Dysfunctions Questionnaire (DASH) will be used to assess disabilities and physical symptoms of the upper limbs. It is a 30-item questionnaire that evaluates the physical disabilities and symptoms of upper limbs in a wide variety of musculoskeletal disorders. The Likert score ranges from 1 to 5 and the total score ranges from 0 to 100, where higher scores represent higher physical disabilities and upper limb symptoms. The questions refer to the last week and the questionnaire items are divided into physical function, symptoms and social function.Questionnaire.	Change from Pre Intervention Upper limb functionality at 6 weeks Post Intervention
Muscle strength	Muscle strength will be assessed by the Kendall scale, graded from 1 to 5.	Change from Pre Intervention Muscle strength at 6 weeks Post Intervention
Range of motion	The range of motion will be evaluated by a goniometer	Change from Pre Intervention Range of motion at 6 weeks Post Intervention
Circumference of the arm	The circumference of the arm will be evaluated by the perimeter.	Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention

Collaborators and Investigators

• Sponsor: University of the State of Santa Catarina
• Investigators: Study Chair: Gilmar M Santos, PhD, Universidade do Estado de Santa Catarina this account disabled

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): February 27, 2020
• Study Completion (ACTUAL): February 27, 2020

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Chronic Pain
• Other Study ID Numbers: Manual Therapy BCS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No