Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery
- Conditions
- Breast Cancer
- Interventions
- Procedure: MassagesProcedure: Mechanical Stimulation
- Registration Number
- NCT04202640
- Lead Sponsor
- Centre Oscar Lambret
- Brief Summary
This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.
- Detailed Description
A prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery.
Other objectives of the study include:
* Evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy.
* Evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 80
- Age > 18 years
- Patient who had total mastectomy for a breast cancer or pre-cancerous lesions
- Associated with axillary dissection or removal of the sentinel lymph nodes
- Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy
- Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment
- Patient covered by the French social security regime
- Signed and informed consent
- Immediate breast reconstruction
- Total bilateral mastectomy
- Contraindication to mechanical stimulation technique
- Patient who are planning to move houses in the next 6 months
- Patients under guardianship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B - Massages Massages Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages. Arm A - Mechanical Stimulation Mechanical Stimulation Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation
- Primary Outcome Measures
Name Time Method Pain level by a numerical scale 6 months after randomization Pain level will be evaluated using a numerical scale of pain
Mobility of the shoulders 6 months after randomization Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4.
Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.Pain level by using Brief Pain Inventory 6 months after randomization Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Pain level by using QDN4 questionnaire 6 months after randomization Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
- Secondary Outcome Measures
Name Time Method Pain level by using Brief Pain Inventory 15 days after the end of physiotherapy Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Pain level by a numerical scale 15 days after the end of physiotherapy Pain level will be evaluated using a numerical scale of pain
Pain level by using QDN4 questionnaire 15 days after the end of physiotherapy Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Anxiety at the baseline and 6 months after Will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression:
* A score equal to or less than 7 indicates no symptoms,
* A score of 8 - 10 indicates a questionable symptoms,
* A score of 11 and above confirms of the presence of anxiety and/or depression symptomsMobility of the shoulders 15 days after the end of physiotherapy Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4.
Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.Quality of Life (QoL) with EORTC-QLQ-C30 at the baseline and 6 months after Will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 30 questions.
In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much.
Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent.Quality of Life (QoL) with EORTC-QLQ-BR23 at the baseline and 6 months after Will be evaluated using the EORTC-QLQ-BR23 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 23 questions.
In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much.
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire de Lille
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, Hauts-de- France, France