Breast CancerNCT02181166
Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies
A study testing Kinesiotherapy, Isquemic compression and High voltage electrical stimulation in people with Breast Cancer and Myofascial Trigger Point, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points. This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Myofascial Trigger Point
- What is being tested?
- Kinesiotherapy, Isquemic compression and High voltage electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Dec 2016
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mastectomy
- aged between 35 and 70 years
- myofascial trigger point in the upper trapezius muscle
Who cannot join
- metastasis or recurrence of breast cancer
- bilateral mastectomy
- in physiotherapy treatment
- degenerative diseases of the spine
- use of muscle relaxants or anti-inflammatory analgesics in the last week
- report of fibromyalgia
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
Vânia Ferreira, PT, +551636020215, vaniatie@hotmail.com
Vânia Ferreira, PT
About this study
Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points. This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer. This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation cinesioterapia +). The stance, the plantar pressure distribution and the balance will be assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points will be assessed with the use of infrared thermography, algometry and numerical rating scale of pain (END). Moreover, the quality of life of the volunteers will be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and after thirty days. Normality test is used to verify data distribution and consistent statistical test for proper intra and comparisons between groups, being thus considered two factors in the comparisons, time and group. A significance level of 5% is assumed.
- Conditions
- Breast Cancer, Myofascial Trigger Point
- Being tested
- Kinesiotherapy, Isquemic compression, High voltage electrical stimulation
- Keywords
- Breast Neoplasms, Mastectomy, Myofascial pain syndromes, Physical Therapy Modalities
- Medical subject headings
- Breast Neoplasms, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotherapyOther
Isquemic compressionOther
High voltage electrical stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| kinesiotherapy + High voltage electrical stimulation | Experimental | Same protocol group kinesiotherapy + high voltage electrial stimulation with two rectangular electrodes (3x5 cm) active silicon-carbon and an electrode rectangular dispersive (10x18cm) aluminum wrapped with a damp felt in water. The active electrodes are positioned in central myofascial trigger point of the upper trapezius muscle after application of water soluble gel. The dispersive electrode was placed in the lumbar region. The following parameters will be use: frequency of 10 Hz, twin pulses of 20μs to 100ms between pulses and the maximum voltage tolerated by voluntary until the motor threshold (visible muscle contraction) to increase every five minutes, totaling 30 minutes of stimulation. The negative polarity will be use. Receives: Other: Kinesiotherapy; Other: High voltage electrical stimulation |
| Kinesiotherapy group | Experimental | The volunteer will be subjected to the following protocol: These exercises involve stretching of the cervical, anterior and posterior chain of the upper trunk and active mobilization of the cervical, shoulder movements of flexion, extension, abduction and adduction of the shoulder and upper limb. The exercises lasted 50 minutes, with 10 minutes of walking, and stretching was performed with two repetitions of 20 seconds, and active mobilization exercises of three sets of eight repetitions and final relaxation of 10 minutes were performed. Receives: Other: Kinesiotherapy |
| kineshioterapy + isquemic compression | Experimental | The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds. Receives: Other: Kinesiotherapy; Other: Isquemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
Measured: 2 years
Secondary outcomes (3)
Quality of life
Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).
Measured: 2 years
Skin Temperature
Through of thermograph will be evaluated skin temperature on myofascial trigger points.
Measured: 2 years
Posture
Through computerized photogrammetry postural assessment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015 (estimated)
- Study completionDec 2016 (estimated)
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vânia Tie Koga Ferreira, University of Sao Paulo
- Investigators
- Vânia Ferreira, PT, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181166
- Sponsor's protocol ID
- U1111-1158-7302
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies
- ClinicalTrials.gov ID
- NCT02181166
- Acronym / sponsor ID
- U1111-1158-7302
- Conditions
- Breast Cancer, Myofascial Trigger Point
- Keywords
- Breast Neoplasms, Mastectomy, Myofascial pain syndromes, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Jul 2014 (estimated)
- 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.
Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points. This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer. This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation cinesioterapia +). The stance, the plantar pressure distribution and the balance will be assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points will be assessed with the use of infrared thermography, algometry and numerical rating scale of pain (END). Moreover, the quality of life of the volunteers will be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and after thirty days. Normality test is used to verify data distribution and consistent statistical test for proper intra and comparisons between groups, being thus considered two factors in the comparisons, time and group. A significance level of 5% is assumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kinesiotherapy + High voltage electrical stimulation | Experimental | Other: Kinesiotherapy, Other: High voltage electrical stimulationSame protocol group kinesiotherapy + high voltage electrial stimulation with two rectangular electrodes (3x5 cm) active silicon-carbon and an electrode rectangular dispersive (10x18cm) aluminum wrapped with a damp felt in water. The active electrodes are positioned in central myofascial trigger point of the upper trapezius muscle after application of water soluble gel. The dispersive electrode was placed in the lumbar region. The following parameters will be use: frequency of 10 Hz, twin pulses of 20μs to 100ms between pulses and the maximum voltage tolerated by voluntary until the motor threshold (visible muscle contraction) to increase every five minutes, totaling 30 minutes of stimulation. The negative polarity will be use. |
| Kinesiotherapy group | Experimental | Other: KinesiotherapyThe volunteer will be subjected to the following protocol: These exercises involve stretching of the cervical, anterior and posterior chain of the upper trunk and active mobilization of the cervical, shoulder movements of flexion, extension, abduction and adduction of the shoulder and upper limb. The exercises lasted 50 minutes, with 10 minutes of walking, and stretching was performed with two repetitions of 20 seconds, and active mobilization exercises of three sets of eight repetitions and final relaxation of 10 minutes were performed. |
| kineshioterapy + isquemic compression | Experimental | Other: Kinesiotherapy, Other: Isquemic compressionThe same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mastectomy
- aged between 35 and 70 years
- myofascial trigger point in the upper trapezius muscle
Key exclusion criteria (6 listed)
- metastasis or recurrence of breast cancer
- bilateral mastectomy
- in physiotherapy treatment
- degenerative diseases of the spine
- use of muscle relaxants or anti-inflammatory analgesics in the last week
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 | Other | Kinesiotherapy group, kineshioterapy + isquemic compression, kinesiotherapy + High voltage electrical stimulation |
| Isquemic compression | Other | kineshioterapy + isquemic compression |
| High voltage electrical stimulation | Other | kinesiotherapy + High voltage electrical stimulation |
Primary outcome
Pain
Time frame: 2 years
Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
3 secondary outcomes
Quality of life
Time frame: 2 years
Skin Temperature
Time frame: 2 years
Posture
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Vânia Ferreira, PT principal investigator
University of Sao Paulo
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, Isquemic compression and High voltage electrical stimulation in people with Breast Cancer and Myofascial Trigger Point, run by University of Sao Paulo 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 2014. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vânia Ferreira, PT (+551636020215, vaniatie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 2 years). 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 3 Jul 2014.