ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000205235

Ethics application status

Approved

Date submitted

5/03/2009

Date registered

23/04/2009

Date last updated

18/06/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Specific Treatment Of Problems of the Spine (STOPS) Trials: Effects of advice versus physiotherapy functional restoration on pain and function for people with lumbar disc herniation and associated radiculopathy.

Scientific title

Effects of advice versus physiotherapy functional restoration on pain and function for people with lumbar disc herniation and associated radiculopathy: A randomised controlled trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

STOPS

Linked study record

Health condition

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

Lumbar disc herniation with associated radiculopathy

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Ten sessions of physiotherapy functional restoration (30-minute sessions at variable frequency) over a 10-week period. This will involve core stabilising exercises, progressive functional exercises, and condition-specific education and advice.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

Two sessions of physiotherapy advice over a 10-week period (one 30-minute session directly after randomisation, and another 30-minute session 5-weeks following randomisation). This will involve condition-specific advice regarding the prognosis and self-management of the condition.

Control group

Active

Outcomes

Primary outcome [1]

Back-specific function (Oswestry Low Back Pain Disability Questionnaire)

Timepoint [1]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Primary outcome [2]

Leg pain intensity on a 0-10 Numerical Rating Scale

Timepoint [2]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Primary outcome [3]

Back pain intensity on a 0-10 Numerical Rating Scale

Timepoint [3]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Secondary outcome [1]

7-point global perceived effect scale.

Timepoint [1]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Secondary outcome [2]

Quality of Life (EuroQOL)

Timepoint [2]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Secondary outcome [3]

Sciatica Frequency and Bothersomeness Scale

Timepoint [3]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Secondary outcome [4]

Rate and nature of adverse events (therapist reporting and open questions to participants). Examples may include increase or new onset of musculoskeletal or neurological symptoms, muscular soreness assoicated with exercises, and any others that are reported or observed.

Timepoint [4]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Secondary outcome [5]

Participant satisfaction (with treatment and outcome) measured on a 5-point scale from "very dissatisfied" to "very satisfied".

Timepoint [5]

At baseline, and 5, 10, 26 and 52 weeks following randomisation

Secondary outcome [6]

Orebro musculoskeletal pain questionnaire

Timepoint [6]

At baseline, and 5, 10, 26 and 52 weeks following randomisation.

Secondary outcome [7]

Number of work days missed in the last 30 days

Timepoint [7]

At baseline, and 5, 10, 26 and 52 weeks following randomisation.

Secondary outcome [8]

Interference with work/housework in the last week, measured on a 5-point scale from "not at all" to "extremely".

Timepoint [8]

At baseline, and 5, 10, 26 and 52 weeks following randomisation.

Eligibility

Key inclusion criteria

Leg pain radiating below the knee (or into the anterior thigh for high lumbar disc herniations) for duration of 6 weeks to 6 months.
At least one neurological sign (reflex deficit, sensory deficit, motor deficit, or positive straight-leg-raise).
Magnetic resonance imaging (MRI) or computerised tomography (CT) confirming the presence of a lumbar disc herniation.
Able to understand and read English.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Causes of symptoms other than disc herniation (spondylolisthesis, bony or ligamentous stenosis). Previous lumbar spine surgery. Compensable injury. Cauda equina syndrome or progressive lower limb weakness. Had injections into the back in the previous 6 weeks. Active cancer. Inability to walk safely.

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)

Volunteers who respond to advertising, or who are referred by a medical practitioner or health care professional, will undergo a phone screening and baseline physical assessment to determine eligibility. Eligible volunteers who consent to participate will complete baseline outcome measures prior to being randomised to the functional restoration or advice group. This will be done by the assessor contacting an off-site trial administrator who will hold the randomisation schedule, and will not be involved in assessing, enrolling or treating participants.

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

A researcher at La Trobe University who will have no contact with participants will generate a randomisation schedule prior to trial commencement. Permuted block randomisation with random block sizes will be undertaken using a web-based randomisation program. Randomisation will be stratified by developing a separate schedule for each of the 14 physiotherapy treatment clinics.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

All participants who are allocated to the functional restoration group will be invited to attend a one-on-one semi-structured interview at the completion of the 10-week intervention period to gain their perspectives on the treatment program.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/04/2009

Actual

28/04/2009

Date of last participant enrolment

Anticipated

Actual

14/11/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

LifeCare Health (a division of Health Networks Australia)

Address [1]

Level 1, 416 High Street
Kew VIC 3101

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

School of Physiotherapy
Faculty of Health Sciences
Victoria 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Faculty Human Ethics Committee

Ethics committee address [1]

La Trobe University
Faculty of Health Sciences
Victoria 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/12/2008

Ethics approval number [1]

FHEC08 / 196

Summary

Brief summary

The primary aim of this trial is to compare the outcomes and adverse events of two different physiotherapy treatment approaches for people with clinical and radiological confirmation of lumbar disc herniation with associated radiculopathy.
A secondary aim is to determine the perspectives of participants on the functional restoration program utilised in the trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew Hahne

Address

Department of Physiotherapy
La Trobe University
Melbourne Victoria 3086

Country

Australia

Phone

+61 3 9479 3392

Fax

Email

[email protected]

Contact person for public queries

Name

Andrew Hahne

Address

School of Physiotherapy
La Trobe University
Victoria 3086

Country

Australia

Phone

+61 408 148 720

Fax

Email

[email protected]

Contact person for scientific queries

Name

Professor Nicholas Taylor

Address

School of Physiotherapy
La Trobe University
Victoria 3086

Country

Australia

Phone

+61 3 9479 5860

Fax

+61 3 9479 5768

Email

[email protected]

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
Embase	Individualized functional restoration as an adjunct to advice for lumbar disc herniation with associated radiculopathy. A preplanned subgroup analysis of a randomized controlled trial.	2017	https://dx.doi.org/10.1016/j.spinee.2016.10.004

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