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Trial registered on ANZCTR


Registration number
ACTRN12615000136505
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
12/02/2015
Date last updated
12/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of massage therapy on secondary conditions in people with spinal cord injury: psychological and physiological outcomes
Scientific title
The effects of massage therapy on secondary conditions in people with spinal cord injury: psychological and physiological outcomes
Secondary ID [1] 286005 0
NIL
Universal Trial Number (UTN)
U1111-1164-7127
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury
293967 0
Anxiety 294073 0
Fatigue 294074 0
Pain 294075 0
Infection 294076 0
Condition category
Condition code
Neurological 294265 294265 0 0
Other neurological disorders
Mental Health 294266 294266 0 0
Anxiety
Inflammatory and Immune System 294267 294267 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty minute Swedish Massage therapy. once a week for five consecutive weeks. The same qualified, experienced massage therapist worked with each subject for 5 weeks. Massage was applied while subject was seated. The same protocol of Swedish Massage was applied to back, neck and arms for each of the 5 sessions per subject. All massage therapists were female.
Intervention code [1] 290984 0
Prevention
Intervention code [2] 290985 0
Rehabilitation
Comparator / control treatment
20 randomly assigned people with spinal cord injury received Guided Imagery (GI). GI was an active placebo and was conducted for 30 minutes once a week for 5 consecutive weeks. GI consisted of the same script read out by same experimenter for each session for each subject. GI started with instructions for deep diaphragmatic breathing, then talked through each of the 5 senses while subject visualised being in their favourite, relaxing place. Finished with deep breathing and then instructed to gently return to here and now.
Control group
Active

Outcomes
Primary outcome [1] 294062 0
Pain: McGill Pain Questionnaire
Timepoint [1] 294062 0
Baseline and after 5 weeks of weekly intervention
Primary outcome [2] 294063 0
Mood, anxiety and fatigue: Profile of Mood States
Timepoint [2] 294063 0
Baseline & after 5 weeks of weekly intervention
Primary outcome [3] 294064 0
Fatigue: Chalders Fatigue Scale
Timepoint [3] 294064 0
Baseline & after 5 weeks of weekly intervention
Secondary outcome [1] 312435 0
Personality: 16PF Scale
Timepoint [1] 312435 0
Baseline & after 5 weeks of weekly intervention
Secondary outcome [2] 312436 0
Anxiety: Spielberger's State/Trait Anxiety Inventory & Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 312436 0
Baseline & after 5 weeks of weekly intervention
Secondary outcome [3] 312437 0
Immune Measures: Lymphocyte enumeration by 4 mls of blood collected in vacutainer tubes by qualified venipuncturist before the first and fifth sessions. Samples were taken at the same time of day for each subject to control for diurnal variations and immediately refrigerated. Then couriered to pathology laboratory within 3 hours. Flow cytometric techniques to calculate lymphocyte numbers.
Timepoint [3] 312437 0
Baseline & after 5 weeks of weekly intervention

Eligibility
Key inclusion criteria
Minimum duration of 12 months since SCI
Spinal injury level at or below C4
Complete or incomplete lesion
Male or female
Fluent in English
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior psychopathology, traumatic brain injury, drug addiction or disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertising for subjects via flyers, SCI organisations and word of mouth.

Participant Information Sheets were sent to people who were interested, describing Research Outline, Requirements of Participants, Monetary contributions, Impact on Participants' Regular Medications and Treatments, Possible Benefits to Participants, Withdrawal Procedures and Confidentiality Procedures.

Consent forms were sent
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once signed Consent forms were received, subjects were assigned a code to de-identify individuals. A piece of paper was randomly taken from a bag that had either C for Control or I for Intervention. Subjects were assigned to that group with their code
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Repeated measures two-group longitudinal design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated measure ANOVA to determine differences between groups as a function over time and interaction effects between intervention and time. A Fisher LSD post hoc test was conducted where significant differences between groups and/or over time and /or interactions were found. Twenty subjects in each group provided statistical power of 50% and allowed a moderate effect size. Sample size was limited by availability of people with SCI with inclusion criteria and able to participate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290595 0
University
Name [1] 290595 0
University of Technology, Sydney
Address [1] 290595 0
PO Box 123
Broadway NSW 2007
Country [1] 290595 0
Australia
Funding source category [2] 290596 0
Charities/Societies/Foundations
Name [2] 290596 0
Sunshine Foundation
Address [2] 290596 0
c/- Mutual Trust P/L
PO Box 12
Collins Street West
MELBOURNE Vic 8007
Country [2] 290596 0
Australia
Funding source category [3] 290597 0
Charities/Societies/Foundations
Name [3] 290597 0
Association of Massage Therapists
Address [3] 290597 0
PO Box 826
Broadway NSW 2007
Country [3] 290597 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
PO Box 123
Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 289284 0
Charities/Societies/Foundations
Name [1] 289284 0
Association of Massage Therapists
Address [1] 289284 0
PO Box 826
Broadway NSW 2007
Country [1] 289284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292230 0
UTS Human Research Ethics Committee
Ethics committee address [1] 292230 0
PO Box 123
Broadway NSW 2007
Ethics committee country [1] 292230 0
Australia
Date submitted for ethics approval [1] 292230 0
Approval date [1] 292230 0
10/01/2006
Ethics approval number [1] 292230 0
Ethics committee name [2] 292231 0
Northern Sydney Central Coast NSW Health Service
Ethics committee address [2] 292231 0
Level 4, Vindin House
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [2] 292231 0
Australia
Date submitted for ethics approval [2] 292231 0
Approval date [2] 292231 0
07/02/2006
Ethics approval number [2] 292231 0
Protocol 0408-185M

Summary
Brief summary
This RCT investigated the efficacy of massage therapy as a non-pharmacological, non-invasive treatment for people with SCI. It found that massage therapy can provide improvements in secondary conditions of SCI such as pain and fatigue
Trial website
Trial related presentations / publications
2013
Craig A., Siddall P., Middleton J., Tran Y., Lovas J., Wijesuriya N., Bartrop R. Developing a model of associations between chronic pain, depressive mood, chronic fatigue and self-efficacy in people with spinal cord injury. The Journal of Pain, 14(9) 911-920

2009
Lovas J. The Effects of Massage Therapy on People with Spinal Cord Injury: Psychological and Immunological Outcomes. Unpublished Doctoral Thesis, University of Sydney

2008
Lovas J. Craig A. Tran Y. & Middleton J. The Effects of Relaxation on Secondary Conditions in Spinal Cord Injury. In Craig A. & Tran Y. (Eds.), Psychological Aspects Associated with Spinal Cord Injury Rehabilitation: New Directions and Best Evidence. New York: Nova Science Publishers, Inc.

2008
Lovas J. Craig A. Tran Y. & Middleton J. (2008). The Role of Massage Therapy in Managing Secondary Conditions Associated with Spinal Cord Injury: An Integrative Model. Topics in Spinal Cord Injury Rehabilitation, 14(1), 61-75

2008
Craig A. Tran Y. Lovas J. & Middleton J. Spinal Cord Injury and its Association with Negative Psychological States. International Journal of Psychosocial Rehabilitation, (12), 115-121
Public notes

Contacts
Principal investigator
Name 54230 0
Dr Judy Lovas
Address 54230 0
School of Psychololgy
Australian Catholic University
C1.35 Edward Clancy Building
Mount St Mary Campus
Locked Bag 2002
Strathfield NSW 2135
Country 54230 0
Australia
Phone 54230 0
+61419433961
Fax 54230 0
Email 54230 0
judymlovas@gmail.com
Contact person for public queries
Name 54231 0
Dr Ashley Craig
Address 54231 0
Rehabilitation Studies Unit
Kolling Institute of Medical Research
University of Sydney
Royal North Shore Hospital
St Leonards NSW 2065
Country 54231 0
Australia
Phone 54231 0
+61 417 290 521
Fax 54231 0
Email 54231 0
a.craig@sydney.edu.au
Contact person for scientific queries
Name 54232 0
Dr Ashley Craig
Address 54232 0
Rehabilitation Studies Unit
Kolling Institute of Medical Research
University of Sydney
Royal North Shore Hospital
St Leonards NSW 2065
Country 54232 0
Australia
Phone 54232 0
+61417 290 521
Fax 54232 0
Email 54232 0
a.craig@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary