Breast CancerNCT04084600
Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors
A study testing Kinesiotherapy Protocol, Manual Therapy Protocol and Traditional Massage in people with Breast Cancer, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Kinesiotherapy Protocol, Manual Therapy Protocol and Traditional Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2019to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Catarina State University
Florianópolis, Santa Catarina, 88080350
About this study
Official title: 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.
Read the 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
- Being tested
- Kinesiotherapy Protocol, Manual Therapy Protocol, Traditional Massage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotherapy ProtocolOther
Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.
Manual Therapy ProtocolOther
Manual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues.
Traditional MassageOther
Traditional Massage is a gentle and superficial massage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Kinesiotherapy Protocol; Other: Traditional Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from Pre Intervention pain dimensions at 6 weeks Post Intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: Change from Pre Intervention Muscle strength at 6 weeks Post Intervention
Range of motion
The range of motion will be evaluated by a goniometer
Measured: 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.
Measured: Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Nov 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Why it stopped: The study had to be stopped due to the COVID-19 pandemic. The University has been closed since the beginning of the pandemic until the present date (02/2021) due to the social distance imposed by the government.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilmar Moraes Santos, PT, University of the State of Santa Catarina
- Investigators
- Gilmar M Santos, PhD, Study chair, Universidade do Estado de Santa Catarina this account disabled
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084600
- Sponsor's protocol ID
- Manual Therapy BCS
- Status last verified
- Feb 2021
- First submitted
- 3 Sep 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Manual Therapy on Chronic Pain and Functionality of Breast Cancer Survivors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04084600
- Acronym / sponsor ID
- Manual Therapy BCS
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study had to be stopped due to the COVID-19 pandemic. The University has been closed since the beginning of the pandemic until the present date (02/2021) due to the social distance imposed by the government.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Kinesiotherapy Protocol, Other: Manual Therapy ProtocolOnce 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. |
| Sham Group | Sham comparator | Other: Kinesiotherapy Protocol, Other: Traditional MassageOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiotherapy ProtocolKinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles. | Other | Intervention Group, Sham Group |
| Manual Therapy ProtocolManual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues. | Other | Intervention Group |
| Traditional MassageTraditional Massage is a gentle and superficial massage. | Other | Sham Group |
Primary outcome
Change in Chronic Pain Intensity
Time frame: Change from Pre Intervention Chronic Pain Intensity at 6 weeks Post Intervention
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 in Pain Location
Time frame: Change from Pre Intervention Pain Location at 6 weeks Post Intervention
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 in Neuropathic Pain
Time frame: Change from Pre Intervention neuropathic pain at 6 weeks Post Intervention
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 in central sensitization pain
Time frame: Change from Pre Intervention central sensitization pain at 6 weeks Post Intervention
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 in pain dimensions
Time frame: Change from Pre Intervention pain dimensions at 6 weeks Post Intervention
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).
4 secondary outcomes
Upper limb functionality
Time frame: Change from Pre Intervention Upper limb functionality at 6 weeks Post Intervention
Muscle strength
Time frame: Change from Pre Intervention Muscle strength at 6 weeks Post Intervention
Range of motion
Time frame: Change from Pre Intervention Range of motion at 6 weeks Post Intervention
Circumference of the arm
Time frame: Change from Pre Intervention Circumference of the arm at 6 weeks Post Intervention
Results and safety
The study was stopped early (reason given: The study had to be stopped due to the COVID-19 pandemic. The University has been closed since the beginning of the pandemic until the present date (02/2021) due to the social distance imposed by the government.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilmar M Santos, PhD study chair
Universidade do Estado de Santa Catarina this account disabled
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotherapy Protocol, Manual Therapy Protocol and Traditional Massage in people with Breast Cancer, run by University of the State of Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study had to be stopped due to the COVID-19 pandemic. The University has been closed since the beginning of the pandemic until the present date (02/2021) due to the social distance imposed by the government.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Chronic Pain Intensity (time frame: Change from Pre Intervention Chronic Pain Intensity at 6 weeks Post Intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.