| - candidate number | 2412 |
| - NTR Number | NTR873 |
| - ISRCTN | ISRCTN31186536 |
| - Date ISRCTN created | 26-feb-2007 |
| - date ISRCTN requested | 21-feb-2007 |
| - Date Registered NTR | 18-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | The efficacy of physiotherapy upon shoulder function following axillary dissection in breast cancer, a pilot study. |
| - Scientific Title | The efficacy of physiotherapy upon shoulder function following axillary dissection in breast cancer, a pilot study. |
| - ACRONYM | N/A |
| - hypothesis | Physiotherapy is effective in patients with mastectomy and axillary lymph node dissection (ALND), for shoulder/arm mobility and pain primarily and quality of life secondarily. |
| - Healt Condition(s) or Problem(s) studied | Breast cancer |
| - Inclusion criteria | 1. 18 years of age and older; 2. Breast cancer with an ALND; 3. A Visual Analogue Scale (VAS)-pain score (0 – 10) of 1 minimally; 4. Moderate shoulder disabilities in daily life (minimal 3 points on a 5 points disability score list). |
| - Exclusion criteria | 1. Patients with a previous contra-lateral mastectomy; 2. Patients with insufficient knowledge of the Dutch language to fill in the questionnaires. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 11-aug-2003 |
| - planned closingdate | 4-nov-2004 |
| - Target number of participants | 30 |
| - Interventions | Patients assigned to the treatment group started physiotherapy two weeks following surgery in a private practice of their own choice. The research assistant contacted the physiotherapist who had to comply with the treatment regime and supplied him or her with information regarding the project and treatment guidelines. This information consisted of: 1. a guideline containing advice and exercises for arm/shoulder, posture correction, coordination exercises, exercises for muscular strength and improvement of the general physical condition; 2. exercises to prevent lymph edema; 3. instruction for scar massage if necessary; 4. a registration form to report the content of the treatment sessions and a 3-point scale to indicate whether the amount of treatment sessions was sufficient. The total number of treatments was nine (nine being usually covered by the healthcare insurance), once or twice weekly for the first three weeks, thereafter once a fortnight or less. Patients were asked to perform home exercises on a daily basis for approximately ten minutes a day. Patients assigned to the control group received a leaflet flyer with advice and exercises for the arm/shoulder for the first weeks following surgery and had no further personal contact with a physiotherapist. |
| - Primary outcome | 1. Shoulder mobility (flexion [0-180°], abduction [0-180°]), measured by use of a digital inclinometer under standardized conditions; 2. Pain in the shoulder/arm, measured using the VAS score (0 – 10, 0 = no pain; 10 = unbearable pain). |
| - Secondary outcome | 1. Disabilities in daily life, measured by the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire (0 – 100, 0 = no functional problems, 100 = maximal problems); 2. Edema (ml), measured in both arms by means of water displacement, grip strength (Kg) of both hands, measured using the hand-held dynamometer and quality of life, as measured by the SIP (Sickness Impact Profile-short version) questionnaire (0 – 68, 0 = good health status; 68 = sever physically disabled). |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Dr. C.H.G. Beurskens |
| - CONTACT for SCIENTIFIC QUERIES | Prof.dr. Th. Wobbes |
| - Sponsor/Initiator | University Medical Center Nijmegen, Dep. Physiotherapy, University Medical Center Nijmegen, Dep. of Surgery |
| - Funding (Source(s) of Monetary or Material Support) | |
| - Publications | BMC Cancer. 2007 Aug 30;7:166. |
| - Brief summary | Physiotherapy is not standard in patients following breast cancer surgery including axillary lymph node dissection (ALND), although many patients suffer from severe shoulder complaints after surgery. The purpose of this study is to gain insight into the efficacy of physiotherapy upon shoulder function, pain and quality of life in patients who have undergone breast cancer surgery and ALND. 30 patients following breast cancer surgery and ALND were included in a randomised controlled trial. Assessments were made at baseline and after three and six months. The treatment group received standardised physiotherapy for three months, the control group a leaflet containing advice and exercises. Physiotherapy treatment consisted primarily of advice and exercises for the arm and shoulder. If necessary scar tissue massage was applied. Primary outcome variables were pain in the shoulder/arm, measured using the Visual Analogue Scale (VAS) score and shoulder mobility (flexion, abduction) measured using a digital inclinometer under standardized conditions. Secondary outcome measures were shoulder disabilities in daily life, edema, grip strength of both hands and quality of life. The researcher was blinded for treatment allocation. 30 patients completed the trial. After three and six months the treatment group showed a significant improvement in shoulder mobility and had significantly less pain than the control group. Quality of life improved significantly, however, handgrip strength and arm volume did not alter significantly. Conclusions are that physiotherapy reduces pain and improves shoulder function and quality of life following axillary dissection in breast cancer. |
| - Main changes (audit trail) | |
| - RECORD | 18-jan-2007 - 16-jun-2008 |
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