ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000269538

Ethics application status

Approved

Date submitted

24/02/2015

Date registered

23/03/2015

Date last updated

13/07/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Does an online psychological intervention improve self-efficacy and disability in people also receiving Multimodal Manual Therapy for chronic low back pain compared to Multimodal Manual Therapy alone? Design of a randomized controlled trial

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Mind Your Back

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be randomly allocated to one of two groups.

Group 1 Multimodal Manual Therapy (Control): Participants in this group will receive Multimodal Manual Therapy treatment (MMT) only. MMT refers to treatment that is centred around manual therapies but also employs best practice primary care and is supported by therapeutic exercises. The manual therapy component of MMT may involve high-velocity, low-amplitude thrust manipulation, non-thrust joint mobilization, or soft tissue massage. The high-velocity, low-amplitude thrust techniques will involve a carefully directed, gentle but quick thrust through the mechanical plane of the spine or pelvic joints that may or may not be accompanied by an audible ‘pop’ or cavitation sound. These techniques may be performed with the therapist’s hands or with the assistance of a device such as a drop-piece table. The non-thrust mobilization techniques will involve passive oscillatory movements of the spine or pelvic joints through normal ranges of motion. Soft tissue massage techniques will be directed at the muscles of the back and pelvis and perfomed with the therapist’s hands or a vibrating massage device. All participants will receive components of best practice primary care that involves reassurance, advice about symptom management and encouragement to remain active. MMT may be supported by exercises that may include general physical conditioning, or specific exercise programs that address; symptom management, or mobility, strength or motor control impairments. Other treatment modalities that are used by chiropractors and physiotherapists that are not endorsed by practice guidlines (e.g. therapeutic ultrasound, transcutaneous electrical nerve simulation, heat therapy, etc) will not be included in the definition of MMT.

All participants in the MMT group will receive manual therapy. The selection of other supportive treatment modalities will be determined by the chiropractor or physiotherapist according to their clinical judgment. Treatments will either be performed by a registered chiropractor or physiotherapist who has more than 5 years of clinical experience. Participants will receive up to 12 treatments over a period of 8 weeks. The practitioner may elect to use fewer treatments in cases where the participant has experienced significant improvement or has developed adverse effects that warrant stopping care. The definition of an adverse effect (event) is either: 1) a new related complaint which was not present at baseline or previous visit, or 2) a worsening of the presenting complaint. Adverse events will be measured using a similar questionnaire as in the side effects of chiropractic treatment study by Leboeuf-Yde et al. and will be carried out at the 8 week follow up interval.

Group 2 MoodGym combined with Multimodal Manual Therapy (Intervention): Participants in this group will receive the same MMT as Group 1; however, this group will also complete the MoodGYM program. Participants will complete one module of the MoodGYM program per week over a five week period. The content of MoodGYM involves the completion of five modules of 20- to 40-minutes duration. The modules use various tools such as interactive games, mood assessments, and downloadable relaxation audio file. The modules focus on aspects of cognitive behaviour therapy, including cognitive restructuring, the relationship between thoughts and feelings, behavioural activation, relaxation, and problem solving. Participants are encouraged to continue their leanings in their daily life by applying principles taught in the modules. Participants in the MoodGYM group will set up a username and password at the time of enrolment and will be given an instruction manual for their five-week online MoodGYM program.

Participants will also receive a weekly telephone reminder, to enhance adherence with the MoodGYM program and avoid attrition. Attrition has been identified as an issue in similar studies and higher completion rates were achieved with occasional telephone or email contact. No additional counseling or treatment advice will be provided with the reminder telephone calls. Participants who report distress as a result of using MoodGym will be offered referral to a clinical psychologist.

Participants in both groups will be given a follow-up appointment schedule for their 8-week course of MMT. The MMT will be provided by a chiropractor or a physiotherapist using techniques listed above which are inaccordance with International Clinical Practice Guidelines for chronic LBP.

Intervention code [1]

Behaviour

Comparator / control treatment

Multimodal Manual Therapy (MMT)

Control group

Active

Outcomes

Primary outcome [1]

Pain Self Efficacy Questionnaire (PSEQ)(Nicholas, 1989)

Timepoint [1]

At baseline and at 2, 6, and 12 months from enrolment

Secondary outcome [1]

Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, & Pivik, 1995)

Timepoint [1]

At baseline and at 2, 6, and 12 months from enrolment

Secondary outcome [2]

Patient Specific Functional Scale (PSFS) (Nicholas MK. 1989)

Timepoint [2]

At baseline and at 2,6 and 12 months from enrolment

Secondary outcome [3]

Roland Morris Disability Questionnaire (Roland & Morris, 1983)

Timepoint [3]

At baseline and at 2, 6, and 12 months from enrolment

Secondary outcome [4]

Depression Anxiety and Stress Scale (DASS21) (Lovibond, 1995)

Timepoint [4]

At baseline and at 2, 6, and 12 months from enrolment

Secondary outcome [5]

Pain intensity Numerical Rating Scale (Jensen MP, 1992a)

Timepoint [5]

At baseline and at 2, 6, and 12 months from enrolment

Secondary outcome [6]

Work Ability Inventory (WAI) (Tuomi, Oja 1998)

Timepoint [6]

At baseline and at 2, 6, and 12 months from enrolment

Eligibility

Key inclusion criteria

Adults who are present for chiropractic or physiotherapy care with a new episode of non-specific lower back pain of more than three months duration.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participants will be excluded if they have been diagnosed with serious spinal pathology (fracture, malignancy, infection, inflammatory disorders, canal stenosis or cauda equina syndrome, spinal cord injury), spinal nerve compromise (determined by the presence of two or more corresponding neurological signs such as dermatomal paresthesia or paresthesis, diminished absent deep tendon reflexes), have undergone spinal surgery in the past 12 months, are pregnant, have a compensation claim related to their back condition, are not able to independently complete English language questionnaires, or are not able to independently use a computer. Score in the low or high risk group on the STarT Back Tool.

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)

In total, 108 participants with chronic LBP who are at moderate risk of long-term disability will be recruited through advertisements placed in the participating practices and in general medical and allied health practices in metropolitan areas in Australia. Consecutive new patients at the participating practices with LBP will be invited to participate. Potential participants will be screened for inclusion by the treating practitioner using the Keel STarT Back Tool and a standardised form during their initial consultation. Those at moderate risk of developing chronic LBP, scoring in the medium risk category on the STarT Back Tool are the focus of this trial. Eligible participants will be provided with written information about the study and invited to participate, and subsequently requested to provide written informed consent.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A researcher who is not involved with participant allocation, treatment, data collection or data analysis will prepare a computer-generated sequence for random allocation to two equal groups. The group allocation for each participant will be placed in consecutively numbered, sealed, opaque envelopes.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Nil

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical methods
The primary data analyses will be conducted using linear mixed models to test for between group differences in post-treatment PSEQ and RMDQ. A covariance structure will be selected that provides the best fit and then will be included as a random factor to adjust for a possible cluster effect of site. A group by time interaction will be included to allow least significant difference (LSD) contrasts to be obtained between groups at each time point. Because linear mixed models allow for missing data points, no imputation of missing data values will be required. Analysis will be by intention-to-treat with the statistician blinded to patient group allocation.
In secondary analyses, analysis of covariance will be used to test whether regression to the mean has occurred, that is whether the patient’s response is related to baseline values. In this, separate analyses will be conducted to determine the effects of treatment at -8, -26 and -52 weeks.

Sample size calculations
With an estimated moderate post-treatment between-group effect size (Glass’s delta) of 0.60 SD, a sample size of 46 per group would be required to show statistical significance (power of 80%, alpha = 0.05) using a LSD post hoc test in a linear mixed model (equivalent to an independent samples t-test). Allowing for a 15% dropout, 108 participants in total will be recruited. We are assuming that the potential loss of power as a result of a cluster effect will be balanced by the use of linear mixed models to negate the effects of missing values and the increased power gained by adjusting for between visit correlations.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

30/03/2015

Actual

10/06/2015

Date of last participant enrolment

Anticipated

31/10/2016

Actual

9/06/2016

Date of last data collection

Anticipated

9/06/2017

Actual

9/06/2017

Sample size

Target

108

Accrual to date

Final

108

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
Discipline of Physiotherapy
Faculty of Health Sciences
Cumberland Campus
75 East St
Lidcombe NSW 2141

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Research Integrity
Research Portfolio
Level 6 Jane Foss Russell
The University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/01/2015

Ethics approval number [1]

2014/997

Summary

Brief summary

This clinical trial outlines the design of a randomised controlled trial that investigates the potential benefits of adding a widely available and inexpensive intervention to standard Multimodal Manual Therapy (MMT).

Numerous chronic low back pain (LBP) Clinical Practice Guidelines have recommended that patient management for LBP should consist of MMT and cognitive behavioural therapy (CBT). MMT and CBT are effective interventions for LBP as standalone treatments. Furthermore; they have the potential to be combined as a secondary intervention for prevention of LBP related disability.

It is also known that higher levels of patient self-efficacy correlate with improvements in disability. CBT is known for its effects on improving self-efficacy. The primary aim of this trial is to assess the effects of combining MMT with MoodGYM on self-efficacy and disability . This study is the first to investigate the secondary prevention of problems in a chronic LBP population using this combined intervention approach.
If this approach shows signs of being effective in reducing long-term disability, it will allow patients, practitioners and other stakeholders who don’t have access to a multidisciplinary team, access to a best practice care tool for the management and secondary prevention of chronic LBP. Furthermore, the outcomes of this trial may produce the beginnings of a tailored interner-based CBT program that can be added to MMT for patients that are at medium risk of developing LBP related disability and pain.

Trial website

Nil

Trial related presentations / publications

Petrozzi, M. J., Leaver, A., Jones, M. K., Ferreira, P. H., Rubinstein, S. M., Mackey. M. G. (2015). "Does an online psychological intervention improve self-efficacy and disability in people also receiving Multimodal Manual Therapy for chronic low back pain compared to Multimodal Manual Therapy alone? Design of a randomized controlled trial." Chiropractic & Manual Therapies 23(1): 1.

Public notes

Attachments [1]

/AnzctrAttachments/367514-Participant Consent Form_APPROVED by HREC clean.pdf

Attachments [2]

/AnzctrAttachments/367514-Patient Info Sheet_APPROVED by HREC clean.pdf

Attachments [3]

/AnzctrAttachments/367514-Waiting room Brochure_APPROVED by HREC clean version.pdf

Attachments [4]

/AnzctrAttachments/367514-HREC Ethics Approval letter 21Jan2015.pdf

Attachments [5]

/AnzctrAttachments/367514-Does and online_Study Protocol_Petrozzi et al 2015 23-35.pdf (Protocol)

Contacts

Principal investigator

Name

Dr Martin G Mackey

Address

The University of Sydney
Discipline of Physiotherapy
Faculty of Health Sciences
75 East St
Rm O171, Bld O C43, Cumberland Campus
Lidcombe NSW 2141

Country

Australia

Phone

+61 2 9351 9374

Fax

[email protected]

Contact person for public queries

Name

Mr John Petrozzi

Address

Petrozzi Wellness Centre 216 Norton st Leichhardt NSW 2040 Australia

Country

Australia

Phone

+ 61 (0)409 557 080

Fax

[email protected]

Contact person for scientific queries

Name

Dr Martin G Mackey

Address

The University of Sydney
Discipline of Physiotherapy
Faculty of Health Sciences
75 East St
Rm O171, Bld O C43, Cumberland Campus
Lidcombe NSW 2141

Country

Australia

Phone

+61 2 9351 9374

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23369	Study protocol

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4503	Study results article	Yes		Petrozzi MJ, Leaver A, Ferreira PH, Rubinstein SM,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Does an online psychological intervention improve self-efficacy and disability in people also receiving Multimodal Manual Therapy for chronic low back pain compared to Multimodal Manual Therapy alone? Design of a randomized controlled trial.	2015	https://dx.doi.org/10.1186/s12998-015-0080-9
Embase	Addition of MoodGYM to physical treatments for chronic low back pain: A randomized controlled trial.	2019	https://dx.doi.org/10.1186/s12998-019-0277-4

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

Trial Review

Documents added manually

Documents added automatically