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Trial registered on ANZCTR


Registration number
ACTRN12608000070336
Ethics application status
Approved
Date submitted
6/02/2008
Date registered
7/02/2008
Date last updated
7/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of spinal manipulative therapy (SMT) versus Graston therapy (GT) in the treatment of non-specific thoracic pain: A randomised controlled trial
Scientific title
In patients with non-specific thoracic pain is spinal manipulative therapy a more effective treatment than Graston therapy or placebo for pain and disability reduction?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non specific Thoracic Pain 2797 0
Condition category
Condition code
Alternative and Complementary Medicine 2932 2932 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal manipulative Therapy- taking the joint slack to the elastic barrier and applying a high velocity, low amplitude thrust at the level and in the direction of notional loss of joint motion; consultation is approximately 15 minutes in duration; 10 sessions over 3-4 weeks
Graston Therapy - a patented form of intrumentation used for soft tissue massage/ mobilisation; 15 minutes in duration; 10 sessions over 3-4 weeks
Intervention code [1] 2537 0
Treatment: Other
Comparator / control treatment
Non functional ultrasound (Placebo) - 5-8 minutes of detuned ultrasound; 10 sessions over 3-4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 3809 0
Oswestry Back pain Disability Index (ODI) - participants must have an index score of greater than 30% at baseline
Timepoint [1] 3809 0
ODI: Baseline, one week after treatment commences, upon completetion of the 4 week intervention period and at 3, 6, 12 months post randomisation
Primary outcome [2] 3814 0
Visual Analogue Scale (VAS)- participants must have a score of 3 or greater out of 10
Timepoint [2] 3814 0
VAS - Baseline, one week after treatment commences, upon completetion of the 4 week intervention period and at 3, 6, 12 months post randomisation
Secondary outcome [1] 6431 0
36-item short form health survey (SF-36) - sociodemographic information such as age, sex, racial ethnicity, education, employment, maritall status and income
Timepoint [1] 6431 0
SF-36 to be taken at baseline

Eligibility
Key inclusion criteria
- Primary complaint of thoracic spine pain from T1-12
- Duration of pain for three months or less
- A VAS score of 3 out of 10or greater and an Oswestry Back Pain Disability index score of greater than 30% at baseline
- Only patients who received a diagnosis of non specific thoracic pain from the screening clinician will be accepted into the study. Diagnosis will be made by questioning and examining the participant. The descriptive classification by Triano et al (1980) will be used to diagnose non specific thoracic spine pain (Midline back pain, Non dermatomal referred pain difficult to localise, No signs of nerve root tension, No major neurological deficit, Pain with compression over the thoracic spine into spine extension. Reduced range of motion)
- Radiographs will be taken when deemed necessary to exclude patients with contraindications to manipulation or other complicating disease, as described in the exclusion criteria. This decision will be based on the criteria set by the National Health and Medical Research Council for Acute Thoracic (AAMPGG, 2003)
- Patients will be accepted into the study if they are able to comply with the treatment protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Are aged less than 18 years
- Pregnant Females
- Have contraindication to manual therapy (inclusive of severe osteoporosis, thoracic fractures, spinal infection, neoplastic disorders, spondyloarthropathy, disc protrusion or generalised infection, i.e. anyone with a temperature greater than 37.5 degrees Celsius)
- Have contraindications to Graston therapy (Cancer, Kidney infection, Anti-coagulant Medication, Rheumatoid arthritis, Uncontrolled hypertension, Unhealed fracture, Inflammatory conditions due to infection, Osteomyelitis)
- Have somatic conditions found on examination to refer pain to the thoracic spine from outside the defined area (inclusive of cervical zygapophyseal joints, muscles and discs)
- Have an active history of visceral conditions referring pain to the thoracic spine (inclusive of myocardial ischaemia, dissecting thoracic aortic aneurysm, peptic ulcer, acute cholecystitis, pancreatitis, renal colic, acute pyelonephritis)
- Current and known substance abuse
- Are not fluent and/ or literate in the English language
- Are currently receiving care for thoracic pain from any other provider
- Cannot commit to full study protocol
- Are currently seeking compensation or have commenced litigation for thoracic spine pain

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)
If the participant generally meets inclusion criteria over the phone they will make an appointment at the Murdoch Chiropractic Clinic. On arrival for their initial consultation they will complete further instruments of measurement. Once the history, physical examination, report of findings and consent has been completed a sealed opaque envelope containing treatment allocation will be handed to the treating student. A software package, ALEA, will be used to generate treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e. computerized sequence generation).For this trial ALEA will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants are randomly assignment to be allocated to one of three groups: Spinal manipulatve therapy, graston therapy of the placebo group (non functional ultrasound)
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
Recruitment postcode(s) [1] 567 0
6000-6999

Funding & Sponsors
Funding source category [1] 3058 0
University
Name [1] 3058 0
Murdoch University
Address [1] 3058 0
Murdoch University
South Street
Murdoch, WA
6152
Country [1] 3058 0
Australia
Primary sponsor type
Individual
Name
Bruce Walker
Address
School of Chiropractic and Sports Science
Murdoch University
South St, Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 2756 0
Individual
Name [1] 2756 0
Amy Crothers
Address [1] 2756 0
Murdoch Chiropractic Clinic
Murdoch University
South St, Murdoch
WA 6152
Country [1] 2756 0
Australia
Other collaborator category [1] 201 0
Individual
Name [1] 201 0
Simon French
Address [1] 201 0
Monash Institute of Health Services
Faculty of Medicine, Nursing and health sciences
Monash University
Victoria, 3800
Country [1] 201 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5010 0
Human Research Ethics Committee, Murdoch University
Ethics committee address [1] 5010 0
Division of Research and Development
Murdoch Unversity
Chancellery Building
South Street
Murdoch 6150
Ethics committee country [1] 5010 0
Australia
Date submitted for ethics approval [1] 5010 0
Approval date [1] 5010 0
29/01/2008
Ethics approval number [1] 5010 0
221107

Summary
Brief summary
At present only one randomized controlled trial has been performed assessing the effectiveness of spinal manipulative therapy on thoracic spinal pain (Schiller 1999). Several limitations were observed resulting in the Schiller concluding that further studies are required.

Graston therapy is a massage system revolving around several hand-held stainless steel instruments (Graston Technique 2006). The founders claim that the instruments have the ability to detect fascial adhesions and restrictions, aiding in achieving improved outcomes for conditions such as thoracic pain (Graston Technique 2006). No high quality trials have been performed to test the efficacy and effectiveness of this method.

Given the popularity of spinal manipulation and massage for back pain and the lack of data there is a need for further high quality studies

The objective of this investigation is to determine the effectiveness of SMT and GT compared to a pseudo-sham in the treatment of non specific thoracic spine pain. Specifically, the null hypotheses are:
1. Perception of pain as measured by a 100mm visual analogue scale (VAS) will not differ between groups after 3 weeks of either SMT, GT or detuned short wave diathermy and detuned ultrasound
2. Function as measured by the Oswestry Back Pain Disability Index will not differ between groups under these study conditions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28351 0
Address 28351 0
Country 28351 0
Phone 28351 0
Fax 28351 0
Email 28351 0
Contact person for public queries
Name 11508 0
Amy Crothers
Address 11508 0
Murdoch Chiropractic Clinic
School of Chiropractic and Sports Science
Murdoch University
South Street, Murdoch
6152
Country 11508 0
Australia
Phone 11508 0
0412 494 661
Fax 11508 0
Email 11508 0
amy.crothers@westnet.com.au
Contact person for scientific queries
Name 2436 0
Amy Crothers
Address 2436 0
Murdoch Chiropractic Clinic
School of Chiropractic and Sports Science
Murdoch University
South Street, Murdoch
6152
Country 2436 0
Australia
Phone 2436 0
0412 494 661
Fax 2436 0
Email 2436 0
amy.crothers@westnet.com.au

No information has been provided regarding IPD availability
Summary results
No Results