A randomised controlled trial to assess the effectiveness of massage for chronic pain

ISRCTN	ISRCTN98406653
DOI	https://doi.org/10.1186/ISRCTN98406653
Protocol serial number	NAPREC 97.053
Sponsor	Royal College of Nursing Institute (UK)
Funder	Oxfordshire Health Services Research Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Kate Seers
Scientific

Whichford House
Building 1400
Parkway Court
Oxford Business Park
Oxford
OX4 2JY
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does massage for chronic non-malignant pain reduce pain and anxiety?
Ethics approval(s)	Oxford Nursing and Allied Professions Ethics Committee (NAPREC) (ref: 97.053)
Health condition(s) or problem(s) studied	Chronic non-malignant pain
Intervention	Intervention: 15 min massage Control intervention: 15 min talk with a nurse about their pain
Intervention type	Other
Primary outcome measure(s)	1. Pain, assessed immediately after massage and 1, 2, 3 and 4 hours later using a Visual Analogue Scale (VAS) and the McGill Pain Questionnaire 2. Anxiety, assessed immediately after massage and 1, 2, 3 and 4 hours later by the short form Spielberg State-Trait Anxiety scale
Key secondary outcome measure(s)	Overall rating of intervention by patient and observer (researcher), assessed by an interview after intervention (normally at 4 hours, however for some of the participants who dropped out of study the interview took place at a earlier timepoint)
Completion date	31/12/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	Patients aged 18 or over attending pain relief unit whose pain was described as moderate or severe.
Key exclusion criteria	1. Non-English speakers 2. Taken analgesics within two hours prior to treatment
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2000

Whichford House

Oxford
OX4 2JY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	04/07/2008		Yes	No