Does addition of a new physiotherapy intervention improve outcomes for patients with low back pain?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611000757910
• Date of registration: 20/07/2011
• Prospective Registration: No
• Primary sponsor: University of Sydney
• 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?
• Date of first enrolment: 14/09/2010
• Target sample size: 64
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12611000757910.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mark Hancock

• Name: Mark Hancock

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Physical Medicine / Rehabilitation - Physiotherapy

Low back pain;
Low back pain

Intervention(s)

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.

Primary Outcome(s)

Low back pain intensity, as measured by Numerical Pain Rating Scale.[6 weeks following entry into trial]

Secondary Outcome(s)

Disability as measured by Roland-Morris Disability Questionnaire[Week 2, 6 and 52]

Function as measured by Patient Specific Functional Scale[Week 2, 6 and 52]

Low back pain intensity, as measured by Numerical Pain Rating Scale.[Week 2 and Week 52]

Secondary ID(s)

Nil

Ethics review

Status: Approved
Approval date:
Contact:

Human Research Ethics Committee