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Effectiveness of myofascial techniques for the prevention and treatment of breast cancer-related dysfunctions of the upper limb.


- candidate number13311
- NTR NumberNTR3610
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2012
- Secondary IDsML8569 METC UZ Leuven
- Public TitleEffectiveness of myofascial techniques for the prevention and treatment of breast cancer-related dysfunctions of the upper limb.
- Scientific TitleEffectiveness of myofascial techniques for the prevention and treatment of breast cancer-related dysfunctions of the upper limb: Randomised controlled trial.
- ACRONYM
- hypothesisThe combination of breast surgery, radiotherapy and chemotherapy have a profound effect on the deep myofascial level and in turn, they create a vicious circle of adhesions and lack of mobility and pain in muscles, fasciae and joints around the shoulder. The effectiveness of myofascial techniques on the prevention and treatment of dysfunctions of the upper limb related to the treatment of breast cancer have never been investigated. Therefore, we want to investigate whether myofascial techniques may have a preventive effect on dysfunctions of the upper limb (applied on breast cancer patients immediately after the axillary lymph node dissection) and whether they are effective to decrease existing dysfunctions of the upper limb (applied on breast cancer patients at least one-year post-surgery with dysfunctions of the upper limb).
- Healt Condition(s) or Problem(s) studiedBreast cancer, Physiotherapy, Unilateral lymph node dissection, Upper limb dysfunctions, Myofascial therapy
- Inclusion criteriaPREVENTIVE STUDY:
1. Primary breast surgery with axillary dissection in the University Hospital Leuven (UZ Leuven);
2. Patient is measured before surgery.

TREATMENT STUDY:
1. Unilateral axillary lymph node dissection at least 1 year ago;
2. Patient has pain of the upper limb.
- Exclusion criteriaPREVENTIVE STUDY:
1. Metastasis of breast cancer;
2. Patients who cannot participate during the entire study period;
3. Patients who are mentally or physically not able to participate in the study.

TREATMENT STUDY:
1. Metastasis;
2. Patients who cannot participate during the entire study period;
3. Patients who are mentally or physically not able to participate in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate31-mrt-2016
- Target number of participants250
- InterventionsPREVENTIVE STUDY:
1. Patients of the intervention group receive a standard physical therapy programme and myofascial techniques;
2. Patients of the control group receive a standard physical therapy programme and a placebo treatment.

The standard physical therapy programme (intervention and control group) is started immediately after the axillary lymph node dissection for breast cancer with a frequency of 2x/week, during 3 months and once a week during 1 month (=30 sessions). Within this programme, patients receive guidelines about the prevention of lymphoedema and exercise therapy.
Application of myofascial techniques or placebo techniques is started 2 months after the axillary lymph node dissection, with a frequency of once a week, during 2 months (=8 sessions). One session takes 30 minutes and consists of myofascial techniques applied on the diaphragm, the scar tissue at the breast, the cervical fascia, the axilla and the pectoral fasciae.

TREATMENT STUDY:
Similar to the ‘preventive group’, in the ‘treatment group’, patients of the intervention group receive a standard physical therapy programme and myofascial techniques. Patients of the control group receive a standard physical therapy programme and a placebo treatment.
The myofascial techniques and placebo treatment will be similar as applied in the ‘preventive group’, so also once a week, but during 3 months (=12 sessions). The standard physical therapy programme will differ. On the one hand, the content of the programme will be adapted for patients with dysfunctions of the upper limb, on the other hand patients receive the first 2 months 2 session per week and the next months 1 session per week (=20 sessions in total).
- Primary outcomePREVENTIVE STUDY:
Do breast cancer patients with a unilateral axillary lymph node dissection and receiving postoperatively standard physiotherapy and myofascial techniques during 4 months have a significantly lower prevalence of pain than patients only receiving standard physiotherapy and placebo? ll patients from the control group and from the experimental group are measured first preoperatively and then postoperatively, 2 months, 4 months, 9 months and 1 year after the breast surgery.

TREATMENT STUDY:
Do breast cancer patients with chronic pain of the upper limb and with a unilateral axillary lymph node dissection, receiving standard physical therapy and myofascial techniques during 4 months have more decrease of pain of the upper limb than patients only receiving standard physical therapy and placebo?
All patients are measured before the start of the treatment programme and after 1, 3, 6 en 12 months.
- Secondary outcomePREVENTIVE STUDY:
Do breast cancer patients with a unilateral axillary lymph node dissection and receiving postoperatively standard physical therapy and myofascial techniques during 4 months have:
1. A significantly lower prevalence of impaired shoulder mobility;
2. A significantly lower prevalence of impaired shoulder function;
3. A significantly lower prevalence of arm lymphoedema;
4. A significantly better quality of life;
5. A significantly better (more normal) shoulder alignment than patients only receiving standard physical therapy and placebo?

TREATMENT STUDY:
Do breast cancer patients with chronic pain of the upper limb and with an unilateral axillary lymph node dissection at least one year ago, receiving standard physical therapy and myofascial techniques during 4 months have:
1. Significantly more improvement of shoulder mobility;
2. Significantly larger improvement of shoulder function;
3. Significantly more decrease of arm volume;
4. Significantly more improvement of quality of life;
5. Significantly more improvement of shoulder alignment;
6. Significantly more recruitment of muscles around the shoulder than patients only receiving standard physical therapy and placebo?
Which factors predict the treatment response in both patient groups?
- TimepointsMonth 1-23: Inclusion of 250 patients;
Month 1-27: Treatments (standard physical therapy from Month 1-27, myofascial techniques from Month 3-27);
Month 1-35: Measurements;
Month 36-37: Statistical analyses and interpretation;
Month 38-42: Utilisation period: writing of papers, organisation of the seminars, presentation of our results on national and international congresses, development of a brochure and website.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES An Groef, de
- CONTACT for SCIENTIFIC QUERIES An Groef, de
- Sponsor/Initiator Kath. Universiteit Leuven, Faculteit Bewegings- en Revalidatiewetenschappen
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryPREVENTIVE STUDY:
All patients planned for an axillary lymph node dissection at the University Hospital Leuven (UZ Leuven) will be measured preoperatively. According to the power at least 200 patients have to participate postoperatively. They will start immediatly after surgery with a standerd physical therapy programma during 4 months. Patients are randomly allocated to the intervention group, receving myofascial therapy two months after surgery, or the control group, receiving placebo therapy also two months after surgery. Shoulder pain, shoulder mobility, shoulder function, arm volume, shoulder alignment and quality of life are measured postoperatively, 2, 4, 9 and 12 months after surgery.

TREATMENT STUDY:
According to the power analysis, fifty patients with an axillary lymph node dissection, at least one year ago and chronic shoulder pain have to be included in the treatment study. They all receive the standard physical therapy programme during 3 months. The intervention group receives additionally myofascial therapy, also during 3 months. The control group receives additionally a placebo therapy, also during 3 months. Shoulder pain, shoulder mobility, shoulder function, arm volume, shoulder alignment, recruitment of muscles of the shoulder girdle and quality of life are measured before the start of the treatment program and after 1, 3, 6 and 12 months.
- Main changes (audit trail)29-Jan-2013: Due to slow inclusion, power has been recalculated, which decreased the number of patients from 200 to 150 - NM
- RECORD11-sep-2012 - 29-jan-2013


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