The efficacy of physiotherapy upon shoulder function following axillary dissection in breast cancer: a pilot study
| ISRCTN | ISRCTN31186536 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31186536 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 05/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C H G Beurskens
Scientific
Scientific
University Medical Centre Nijmegen (UMCN)
Afd. Fysiotherapie 645
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | + 31 (0)24 361 3812 |
|---|---|
| c.beurskens@fysiocss.umcn.nl |
Study information
| Study design | Randomised, active controlled, parallel group, single blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Added as of 05/09/2007: The regional medical ethics board approved the study. |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | 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 oedema 3. Instruction for scar massage if necessary 4. A registration form to report the content of the treatment sessions and a three-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. |
| Intervention type | Other |
| Primary outcome measure | 1. Shoulder mobility (flexion [0 - 180°], abduction [0 - 180°]), measured by use of a digital inclinometer under standardised conditions 2. Pain in the shoulder/arm, measured using the VAS score (zero to ten, zero = no pain, ten = unbearable pain) |
| Secondary outcome measures | 1. Disabilities in daily life, measured by the DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire (zero to 100, zero = no functional problems, 100 = maximal problems) 2. Oedema (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 (zero to 68, zero = good health status, 68 = sever physically disabled) |
| Overall study start date | 11/08/2003 |
| Completion date | 04/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. 18 years of age and older 2. Breast cancer with an ALND 3. A Visual Analogue Scale (VAS)-pain score (zero to ten) of one minimally 4. Moderate shoulder disabilities in daily life (minimal three points on a five points disability score list) |
| Key exclusion criteria | 1. Patients with a previous contra-lateral mastectomy 2. Patients with insufficient knowledge of the Dutch language to fill in the questionnaires |
| Date of first enrolment | 11/08/2003 |
| Date of final enrolment | 04/11/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Nijmegen (UMCN)
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
University Medical Centre Nijmegen (UMCN) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Physiotherapy
Nijmegen
6500 HB
Netherlands
"ROR" |
https://ror.org/05wg1m734 |
|---|
Funders
Funder type
Other
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 30/08/2007 | Yes | No |
