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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20742
Enrollment
150
Registered
2012-09-11
Start date
2012-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer, unilateral lymph node dissection, upper limb dysfunctions, physiotherapy, myofascial therapy

Interventions

PREVENTIVE 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

Sponsors

Kath. Universiteit Leuven, Faculteit Bewegings- en Revalidatiewetenschappen Tervuursevest 101 3001 Leuven-Heverlee Belgium
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PREVENTIVE 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 criteria

Exclusion criteria: PREVENTIVE 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.

Design outcomes

Primary

MeasureTime frame
PREVENTIVE 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

MeasureTime frame
PREVENTIVE 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?

Contacts

Public ContactAn Groef, de

UZ Leuven Dienst Fysische Geneeskunde en Revalidatie Herestraat 49

an.degroef@faber.kuleuven.be-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)