Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000757910
Ethics application status
Approved
Date submitted
5/07/2011
Date registered
20/07/2011
Date last updated
20/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does addition of a new physiotherapy intervention improve outcomes for patients with low back pain?
Scientific title
Does addition of visceral manipulation improve pain, disability and functional outcomes for low back pain patients, compared to standard physiotherapy management?
Secondary ID [1] 262546 0
Nil
Universal Trial Number (UTN)
U1111-1122-5871
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 268209 0
Condition category
Condition code
Musculoskeletal 268339 268339 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 268491 268491 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manipulation of the thoracic, abdominal and pelvic organs and their associated supportive ligaments, connective tissue and fascia. In addition, joint manipulation, specific exercise and functional exercise prescription included in treatment. Treatments will be administered 1-2 x week for a maximum of 12 treatments over 6 weeks. Treatment sessions will last 30 mins and will be administered by an experienced physiotherapist with specialist training in joint manipulation and visceral manipulation. This frequency will be determined according to need.
Intervention code [1] 266885 0
Treatment: Other
Intervention code [2] 267004 0
Rehabilitation
Comparator / control treatment
Joint manipulation, specific exercise and functional exercise prescription as per intervention group. Sham/placebo manipulation of thoracic, abdominal and pelvic organs and their associated soft tissues. Sham manipulation consists of a light touch around the abdomen with no real intention to cause any motion or effect. The area chosen for sham treatment will have no ligamentous, neural or functional connection to the subjects symptomatic presentation. It is planned that both control and active group participants will attend for roughly the same frequency and duration of treatments. However, as this RCT is taking place in a private clinic, with subjects paying as per non-RCT patients, we cannot fully control these variables.
Control group
Placebo

Outcomes
Primary outcome [1] 269126 0
Low back pain intensity, as measured by Numerical Pain Rating Scale.
Timepoint [1] 269126 0
6 weeks following entry into trial
Secondary outcome [1] 276983 0
Low back pain intensity, as measured by Numerical Pain Rating Scale.
Timepoint [1] 276983 0
Week 2 and Week 52
Secondary outcome [2] 276984 0
Disability as measured by Roland-Morris Disability Questionnaire
Timepoint [2] 276984 0
Week 2, 6 and 52
Secondary outcome [3] 276985 0
Function as measured by Patient Specific Functional Scale
Timepoint [3] 276985 0
Week 2, 6 and 52

Eligibility
Key inclusion criteria
To take part in the trial, participants must meet all of the following criteria:
Primary area of complain extending from the 12th rib to the buttock crease.
New episode of LBP. This is defined as an episode which was preceded by a period of at least one month without LBP
LBP symptoms which have a score of 3/10 or more on numerical pain rating scale
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology Nerve root compromise evidenced by at least two of the following (i) myotomal weakness, (ii) dermatomal or widespread sensory loss, (iii) hypo or hyper-reflexia of the lower limb reflexes.
Spinal surgery within the preceding six months.
If currently receiving any other physical therapy for LBP
If pregnant or intending to become pregnant.
Currently taking medications that significantly alter gut motility
Currently taking medications such as oral cortico-steroids which are known to increase the risk of intestinal perforation
A known gastrointestinal disease that associates with a risk of intestinal perforation e.g. Crohn’s disease, diverticular disease, peptic ulcer disease
Known to be taking anti-platelet medications such as Warfarin and Clopidogrel

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)
When a patient organises an initial appointment to see one of the treating physiotherapists, they are informed that they may be asked to participate in a trial. When they arrive, they fill in their baseline measurements. After the history and physical examination, if the therapist is assured all the criteria are met, the patient is asked if they would like to participate in the trial. Any questions are answered. Once approval is gained from the participant, the next sealed opaque randomisation envelope is opened. The participant is treated according to the protocol for the group they are allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random number generator in excel was used to generate the randomisation sequence. This was done by a researcher not involved in patient recruitment or treatment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267371 0
Self funded/Unfunded
Name [1] 267371 0
Country [1] 267371 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 266436 0
None
Name [1] 266436 0
Address [1] 266436 0
Country [1] 266436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269349 0
Human Research Ethics Committee
Ethics committee address [1] 269349 0
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [1] 269349 0
Australia
Date submitted for ethics approval [1] 269349 0
Approval date [1] 269349 0
01/09/2010
Ethics approval number [1] 269349 0
13036

Summary
Brief summary
This study is designed to investigate whether the addition of an extra treatment improves low back pain, compared to standard physiotherapy treatment. The extra treatment consists of gentle manipulation of the organs of the chest, abdomen and pelvis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32821 0
Address 32821 0
Country 32821 0
Phone 32821 0
Fax 32821 0
Email 32821 0
Contact person for public queries
Name 16068 0
Mark Hancock
Address 16068 0
Faculty of Health Science
University of Sydney
NSW 2006
Country 16068 0
Australia
Phone 16068 0
+61 2 93519312
Fax 16068 0
+61 2 93519601
Email 16068 0
mark.hancock@sydney.edu.au
Contact person for scientific queries
Name 6996 0
Mark Hancock
Address 6996 0
Faculty of Health Science
University of Sydney
NSW 2006
Country 6996 0
Australia
Phone 6996 0
+61 2 9351 9312
Fax 6996 0
+61 2 9351 9601
Email 6996 0
mark.hancock@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes the addition of visceral manipulation alter outcomes for patients with low back pain? A randomized placebo controlled trial.2015https://dx.doi.org/10.1002/ejp.614
N.B. These documents automatically identified may not have been verified by the study sponsor.