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
Protocol serial number	N/A
Sponsor	University Medical Centre Nijmegen (UMCN) (The Netherlands)
Funder	Not provided at time of registration

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

University Medical Centre Nijmegen (UMCN)
Afd. Fysiotherapie 645
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Phone	+ 31 (0)24 361 3812
Email	c.beurskens@fysiocss.umcn.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, single blinded multicentre trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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)
Completion date	04/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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