PainNCT02798263
Breast Cancer Rehabilitation With Acupuncture and Physical Therapy Protocol
A study testing Kinesiotherapy, Acupuncture and Stiper in people with Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The pain is very common complaint, and the neck is one of the most affected spots, mainly due to muscle contracture of the cervical and scapular region, triggered by emotional stress associated with muscle retraction involved resulting from postoperative scarring or post-radiotherapy.O fear fibrosis move the limb and… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Kinesiotherapy, Acupuncture and Stiper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Jun 2021
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent surgical treatment of breast cancer, radical or conservative, and exhibiting pain in the region of the shoulder girdle and upper limb, including thoracic and cervical spine after three months of surgery
- Patients should be older than 18 years
- Level of pain ≥ 3 on the Visual Analogue Scale (VAS)
Who cannot join
- Bilateral breast surgery
- Metastatic disease
- Vascular disorders and tactile sensitivity, with diabetes mellitus type I and II and decompensated with lower education level than four years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trials of Acupuncture Effectiveness in the Rehabilitation of Women Under the Physical and Functional Dysfunction to Surgical Treatment of Breast Cancer
The pain is very common complaint, and the neck is one of the most affected spots, mainly due to muscle contracture of the cervical and scapular region, triggered by emotional stress associated with muscle retraction involved resulting from postoperative scarring or post-radiotherapy.O fear fibrosis move the limb and inactivity postoperative lead to gradual impairment of muscle strength and flexibility, and loss of ADM, which also predisposes to the appearance of pain.
Goals Study the effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing surgery for breast cancer.
Read more
- Presence of pain by Visual Analog Scale of Pain (VAS).
- Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation
- lymphedema presence through top member perimetry.
- upper limb function through the DASH questionnaire.
- Depressive symptoms through BECK questionnaire.
- Quality of life through the EORTC questionnaire.
- Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company.
Patients will be divided into three randomized groups with 30 patients per group, who will receive weekly treatment for 10 weeks, and the group I treated with standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and exercises for ADM upper limb lasting 30 minutes; group II is treated com30 minutes classical acupuncture using pre-defined spots, and finally, grupoIII be used in the same acupuncture points of the group II, but using the Stiper® in place of the needles. If the patients in groups II and III still of pain at the end of 10 sessions will be treated complementarily with kinesiotherapy.
Read the detailed description
Objectives General Study the effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing surgery for breast cancer.
Specific
To evaluate the (the):
- Presence of pain by Visual Analog Scale of Pain (VAS).
- Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation
- lymphedema presence through top member perimetry.
- upper limb function through the DASH questionnaire.
- Depressive symptoms through BECK questionnaire.
- Quality of life through the EORTC questionnaire.
- Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company. rationale The increased incidence of breast cancer and successful treatment result in greater survival. These patients may have chronic condition of pain in the area of the shoulder girdle and upper limb, including the thoracic and cervical spine. Knowing that in our previous project in which the group treated only with kinesiotherapy showed good results and when joined acupuncture no superiority, the investigators created new research study in order to determine whether acupuncture and Stiper® in isolated groups, would present equivalence results when compared to kinesiotherapy.The investigators propose then treat with acupuncture and analyze the rehabilitation of these patients. methodology This study will be performed at the Clinic of the Department of Mastology the Department of Gynecology, Federal University of São Paulo (UNIFESP) - Paulista School of Medicine (EPM). Patients will be recruited, selected and informed about the study objectives, relevance, activities to be developed and the possibility of improvement, as well as answer your questions and concerns about the disease. Later the patients who wish to participate in the study protocol will sign a consent form and specific savy for this project.
- Conditions
- Pain
- Being tested
- Kinesiotherapy, Acupuncture, Stiper
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotherapyOther
Compare the standard treatment of pain, by kinesiotherapy versus acupuncture and Stiper.Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.
AcupunctureOther
30 minutes of classical acupuncture using predefined points.
StiperOther
They will be used the same acupuncture points of the group II, but using the needles in place Stiper.
| Study group | Role | What they receive |
|---|---|---|
| Group I kinesiotherapy | Experimental | Treated with standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes Receives: Other: Kinesiotherapy |
| : Group II Acupuncture | Experimental | Treated with 30 minutes of classical acupuncture using predefined points Receives: Other: Acupuncture |
| Group III Stiper | Experimental | They will be used the same acupuncture points of the group II, but using the needles in place Stiper® Receives: Other: Stiper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain
Presence of pain by Visual Analog Scale of Pain (VAS).
Measured: four years
Secondary outcomes (6)
shoulder range of motion
Shoulder range of motion by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation in degrees
Measured: four years
lymphedema presence
lymphedema presence through top member perimetry(centimeters).
Measured: four years
upper limb function
upper limb function through the DASH questionnaire.
Measured: four years
depressive symptoms
Depressive symptoms through BECK questionnaire.
Measured: four years
quality of life of patients after breast cancer surgery
Quality of life through the EORTC questionnaire.
Measured: four years
muscle strength
Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company(Kg).
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Facina, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798263
- Sponsor's protocol ID
- FUSaoPaulo PT 4
- Status last verified
- Jan 2022
- First submitted
- 16 May 2016
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trials of Acupuncture Effectiveness in the Rehabilitation of Women Under the Physical and Functional Dysfunction to Surgical Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT02798263
- Acronym / sponsor ID
- FUSaoPaulo PT 4
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 14 Jun 2016 (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.
The pain is very common complaint, and the neck is one of the most affected spots, mainly due to muscle contracture of the cervical and scapular region, triggered by emotional stress associated with muscle retraction involved resulting from postoperative scarring or post-radiotherapy.O fear fibrosis move the limb and inactivity postoperative lead to gradual impairment of muscle strength and flexibility, and loss of ADM, which also predisposes to the appearance of pain.
Goals Study the effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing surgery for breast cancer.
- Presence of pain by Visual Analog Scale of Pain (VAS).
- Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation
- lymphedema presence through top member perimetry.
- upper limb function through the DASH questionnaire.
- Depressive symptoms through BECK questionnaire.
- Quality of life through the EORTC questionnaire.
- Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company.
Patients will be divided into three randomized groups with 30 patients per group, who will receive weekly treatment for 10 weeks, and the group I treated with standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and exercises for ADM upper limb lasting 30 minutes; group II is treated com30 minutes classical acupuncture using pre-defined spots, and finally, grupoIII be used in the same acupuncture points of the group II, but using the Stiper® in place of the needles. If the patients in groups II and III still of pain at the end of 10 sessions will be treated complementarily with kinesiotherapy.
Detailed description
Objectives General Study the effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing surgery for breast cancer.
Specific
To evaluate the (the):
- Presence of pain by Visual Analog Scale of Pain (VAS).
- Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation
- lymphedema presence through top member perimetry.
- upper limb function through the DASH questionnaire.
- Depressive symptoms through BECK questionnaire.
- Quality of life through the EORTC questionnaire.
- Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company. rationale The increased incidence of breast cancer and successful treatment result in greater survival. These patients may have chronic condition of pain in the area of the shoulder girdle and upper limb, including the thoracic and cervical spine. Knowing that in our previous project in which the group treated only with kinesiotherapy showed good results and when joined acupuncture no superiority, the investigators created new research study in order to determine whether acupuncture and Stiper® in isolated groups, would present equivalence results when compared to kinesiotherapy.The investigators propose then treat with acupuncture and analyze the rehabilitation of these patients. methodology This study will be performed at the Clinic of the Department of Mastology the Department of Gynecology, Federal University of São Paulo (UNIFESP) - Paulista School of Medicine (EPM). Patients will be recruited, selected and informed about the study objectives, relevance, activities to be developed and the possibility of improvement, as well as answer your questions and concerns about the disease. Later the patients who wish to participate in the study protocol will sign a consent form and specific savy for this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I kinesiotherapy | Experimental | Other: KinesiotherapyTreated with standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes |
| : Group II Acupuncture | Experimental | Other: AcupunctureTreated with 30 minutes of classical acupuncture using predefined points |
| Group III Stiper | Experimental | Other: StiperThey will be used the same acupuncture points of the group II, but using the needles in place Stiper® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Underwent surgical treatment of breast cancer, radical or conservative, and exhibiting pain in the region of the shoulder girdle and upper limb, including thoracic and cervical spine after three months of surgery
- Patients should be older than 18 years
- Level of pain ≥ 3 on the Visual Analogue Scale (VAS)
Key exclusion criteria (3 listed)
- Bilateral breast surgery
- Metastatic disease
- Vascular disorders and tactile sensitivity, with diabetes mellitus type I and II and decompensated with lower education level than four years
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 |
|---|---|---|
| KinesiotherapyCompare the standard treatment of pain, by kinesiotherapy versus acupuncture and Stiper.Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes. | Other | Group I kinesiotherapy |
| Acupuncture30 minutes of classical acupuncture using predefined points. | Other | : Group II Acupuncture |
| StiperThey will be used the same acupuncture points of the group II, but using the needles in place Stiper. | Other | Group III Stiper |
Primary outcome
Presence of pain
Time frame: four years
Presence of pain by Visual Analog Scale of Pain (VAS).
6 secondary outcomes
shoulder range of motion
Time frame: four years
lymphedema presence
Time frame: four years
upper limb function
Time frame: four years
depressive symptoms
Time frame: four years
quality of life of patients after breast cancer surgery
Time frame: four years
muscle strength
Time frame: four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Acupuncture and Stiper in people with Pain, run by Federal University of São 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 3 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: finished, as of the sponsor's last update on 26 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of pain (time frame: four 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 26 Jan 2022.