ANZCTR - Registration

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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

Condition category

Condition code

Alternative and Complementary Medicine

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]

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]

Oswestry Back pain Disability Index (ODI) - participants must have an index score of greater than 30% at baseline

Timepoint [1]

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]

Visual Analogue Scale (VAS)- participants must have a score of 3 or greater out of 10

Timepoint [2]

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]

36-item short form health survey (SF-36) - sociodemographic information such as age, sex, racial ethnicity, education, employment, maritall status and income

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

18/02/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6000-6999

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch University

Address [1]

Murdoch University
South Street
Murdoch, WA
6152

Country [1]

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]

Individual

Name [1]

Amy Crothers

Address [1]

Murdoch Chiropractic Clinic
Murdoch University
South St, Murdoch
WA 6152

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Simon French

Address [1]

Monash Institute of Health Services
Faculty of Medicine, Nursing and health sciences
Monash University
Victoria, 3800

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, Murdoch University

Ethics committee address [1]

Division of Research and Development
Murdoch Unversity
Chancellery Building
South Street 
Murdoch 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/01/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Amy Crothers

Address

Murdoch Chiropractic Clinic
School of Chiropractic and Sports Science
Murdoch University
South Street, Murdoch
6152

Country

Australia

Phone

0412 494 661

Fax

amy.crothers@westnet.com.au

Contact person for scientific queries

Name

Amy Crothers

Address

Murdoch Chiropractic Clinic
School of Chiropractic and Sports Science
Murdoch University
South Street, Murdoch
6152

Country

Australia

Phone

0412 494 661

Fax

amy.crothers@westnet.com.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

Source	Title	Year of Publication	DOI
Dimensions AI	Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: Design of a randomised controlled trial	2008	https://doi.org/10.1186/1746-1340-16-12
Embase	Spinal manipulative therapy, Graston technique and placebo for non-specific thoracic spine pain: A randomised controlled trial.	2016	https://dx.doi.org/10.1186/s12998-016-0096-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically