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

NCT04084600 | Terminated

• 1 other identifier: Manual Therapy BCS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Upper limb functionality

  Change from Pre Intervention Upper limb functionality at 6 weeks Post Intervention

• Muscle strength

  Change from Pre Intervention Muscle strength at 6 weeks Post Intervention

• Range of motion

  Change from Pre Intervention Range of motion at 6 weeks Post Intervention

• Circumference of the arm

  Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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; Other: Manual Therapy Protocol

Sham Group

SHAM COMPARATOR

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; Other: Traditional Massage

Interventions

Kinesiotherapy Protocol OTHER

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

Intervention Group; Sham Group

Manual Therapy Protocol OTHER

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

Intervention Group

Traditional Massage OTHER

Traditional Massage is a gentle and superficial massage.

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Santa Catarina State University

Florianópolis, Santa Catarina, 88080350, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Medicine, Thai Traditional

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Gilmar M Santos, PhD

  Universidade do Estado de Santa Catarina this account disabled

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 10, 2019
• Study Start: November 1, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

BR (1)