Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000042246
Ethics application status
Approved
Date submitted
14/12/2017
Date registered
15/01/2018
Date last updated
14/03/2022
Date data sharing statement initially provided
19/03/2019
Date results information initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two models of education and advice in experimental low back pain
Scientific title
Effect of Injury Model Education & Advice Vs Temporary Sensitisation Model Education & Advice on Pain Intensity in People With Exercise Induced Muscle Soreness Of The Lumbar Spine
Secondary ID [1] 293500 0
Nil known
Universal Trial Number (UTN)
U1111-1206-0472
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 305687 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304908 304908 0 0
Physiotherapy
Musculoskeletal 304909 304909 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 304910 304910 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Base line testing and the intervention will will take place at Research Labs at Department of Health Science and Technology, Aalborg Universitet, Frederik Bajers Vej 7, 9220, Aalborg. The session is expected to last under 60 minutes.

All participants will be asked to report (online) their daily symptoms and will be requested to the following week.

Session 1
50 eligible, healthy, weight training naïve persons will be recruited. During Session 1 they will have baseline testing of all outcomes including pressure pain thresholds, questionnaire information, pain intensity on a numerical rating scale and movement evoked pain intensity on a numerical rating scale (See section: Outcomes).

They will then be asked to perform exercises of the lumbar muscles. Participants will be requested to perform 4 sets of lumbar extension exercises until volitional fatigue. All exercise will be overseen by a qualified physiotherapist. The aim is to induce delayed onset muscle soreness (DOMS), a benign and temporary endogenous experimental pain. The exercise will only performed at the commencement of the study, it will not be repeated during follow up sessions.

Baseline tests will be repeated at this point. Theses tests will be performed by a tester who will be blinded to group allocation.

They will then be randomised into 2 arms which will each receive an advice based intervention from a qualified physiotherapist. These will be delivered in a face-to-face format with a predetermined script. They will also give the participant written material to re-inforce the particular messaging / advice. As these interventions are used in clinical practice but have not been compared in this way previously, they may both be considered active interventions. The only difference between the groups will be different information as to the cause of their pain and the advice they receive for the following days. Below are the intervention arms:

Arm 1: Temporary Sensitisation Model Education & Advice:
Arm 2: Injury Model Education & Advice:

Immediately after receiving the education and advice, all baseline test will be repeated (again, blinded to allocation).

The exercises will not be repeated. At the completion of testing on day 7, all participants will be de-briefed on the nature of the study / interventions via an online meeting.

Arm 1: Temporary Sensitisation Model Education & Advice:
This group will be advised that their muscles will likely become sensitive as a normal result of doing an unaccustomed exercise. They will be informed that there is no real injury and the best thing to can do in the next few days is to stay active and move normally and freely and to avoid guarding the back form movement.
Intervention code [1] 299739 0
Rehabilitation
Comparator / control treatment
Arm 2: Injury Model Education & Advice:
They will receive advice and education based on the usual clinical practice model which encourages rest such as avoid bending it in the beginning. The physiotherapist will explain that the exercise causes damage to muscle fibres and the fatigue is a signal the body needs rest / protection. The transient pain will be suggested to result from this transient damage. They will be advised to limit the movement of the back during daily tasks over the following days. The physiotherapist will demonstrate and teach the participant movement strategies that emphasise keeping the back straight during daily tasks such as getting out of bed or picking up an object from the floor.
Control group
Active

Outcomes
Primary outcome [1] 304102 0
Movement Evoked Pain Intensity - the participant will be asked to bend forward as far as possible and to rate their pain on a numerical rating scale (NRS)
Timepoint [1] 304102 0
Baseline (pre-exercise), immediately post exercise (prior to allocation / intervention), immediately post intervention, Then reported upon daily in diary.
Secondary outcome [1] 340989 0
Pain Catastrophization using the Pain Catastrophizing Scale (PCS),
Timepoint [1] 340989 0
Baseline (pre-exercise), immediately post exercise (prior to allocation / intervention), immediately post intervention, Then reported upon daily in diary.

There will be no follow up, in-person testing sessions.

Secondary outcome [2] 340990 0
Kinesiophobia using an adapted version of the Tampa Scale for Kinesiophobia (TSK),
Timepoint [2] 340990 0
Baseline (pre-exercise), immediately post exercise (prior to allocation / intervention), immediately post intervention, Then reported upon daily in diary.


There will be no follow up, in-person testing sessions.
Secondary outcome [3] 340991 0
Pressure pain threshold (lumbar muscles and over tibialis anterior muscle) measured using hand held algometer

Timepoint [3] 340991 0
Baseline (pre-exercise), immediately post exercise (prior to allocation / intervention), immediately post intervention,

There will be no follow up, in-person testing sessions.
Secondary outcome [4] 341819 0
Daily activity average pain intensity reported using a numerical rating scale from 0 (Not affected at all ) - 10 (Affects all activities of daily life)
Timepoint [4] 341819 0
Reported upon daily in diary

Eligibility
Key inclusion criteria
We will recruit from a healthy population. Inclusion criteria includes proficient written and spoken Danish and the ability to provide written informed consent.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants to be excluded if they reported any form of persistent pain, had lower limb pain or low back pain that required a visit to a health care professional within the previous 12 months, sustained a traumatic injury (e.g. fracture or dislocation) of the lower limb or spine within the previous five years, had any ongoing medical or neurological conditions, consume regular anticoagulant medication or medications known to influence pain sensitivity (e.g. painkillers, anti-inflammatories, anti-depressants) or if they had recently trained the low back or legs with strength exercises (within the previous six-months).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A power analysis using G Power 3.1.9.2 (Heinrich Heine University, Dusseldorf Germany) was used to estimate the sample size. With the significance level set at p<0.05, a 0.5 correlation among repeated measures, and the effect size for differences between groups estimated to be small (0.2), it was determined that a total of 20 per group (two groups) would yield a power of 0.90. It is intended to recruit 25 in each group to allow for drop out.

Dependent variables of interest will be analysed using Generalised Linear Mixed Model regression analyses, which take into account the repeated measures nature of this design. The primary independent variable will be education group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
8/07/2022
Actual
Sample size
Target
50
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 9406 0
Denmark
State/province [1] 9406 0
Aalborg

Funding & Sponsors
Funding source category [1] 298121 0
University
Name [1] 298121 0
University of Notre Dame Australia
Country [1] 298121 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle,
Western Australia 6959
Country
Australia
Secondary sponsor category [1] 297201 0
None
Name [1] 297201 0
Address [1] 297201 0
Country [1] 297201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299138 0
Regional Ethics Comittee Northern Denmark
Ethics committee address [1] 299138 0
Niels Bohrs Vej 30
9220 Aalborg Ost
Ethics committee country [1] 299138 0
Denmark
Date submitted for ethics approval [1] 299138 0
Approval date [1] 299138 0
08/12/2017
Ethics approval number [1] 299138 0
N-20150048

Summary
Brief summary

Low back pain (LBP) represents a high social and economic burden and recent data suggests it is becoming an increasing problem. Further complicating the clinical picture is the presence of diverging approaches regarding how best to advise and manage persons with an acute episode of LBP.

Over the past 20 years, there has been increasing support for a bio-psychosocial approach to the management of LBP. This model considers pain as a symptom not solely driven by tissue damage or pathology. Instead psychological and social influences such as fear avoidance, psychological distress, compensation or litigation status and job satisfaction are considered to contribute the pain experience. This bio-psychosocial model is in direct contrast to the prevailing historical model, the biomedical model which explains pain as a direct function of structural pathology.

Central to the management of an acute episode of LBP and the prevention of chronic symptoms is the initial consultation between a patient with LBP and a health practitioner. Whether the practitioner subscribes to a biomedical or bio-psychosocial school of thought will determine the advice and management dispensed in a bout of uncomplicated acute LBP.

Advice based on the biomedical model can be labelled Injury Model advice (IM), explaining the individuals’ symptoms in the context of tissue damage and emphasising initial protection of the injured tissue to optimise healing and recovery. The focus on specific diagnosis may appear intuitively reassuring, however there is evidence suggesting that having diagnostic radiology and a specific diagnosis may not actually provide reassurance. Furthermore, it has been suggested that emotional distress in acute LBP increases costly and inappropriate healthcare consultations. It is unknown whether being informed of tissue damage or a structural diagnosis actually increases the pain experience through cognitive or psychological drivers.

The bio-psychosocially driven approach focuses on tissue sensitivity rather than injury and recognises that multiple factors interact to give rise to the sensitivity state. In this Tissue Sensitisation Model (TSM) providing reassurance and encouraging movement and function are seen as the key strategies to optimising recovery. This research aims for the first time to directly compare the efficacy of these two approaches to managing acute LBP.

Using a safe, self-limiting and established delayed onset of muscle soreness protocol as a proxy for acute low back pain, we will compare the effect of the two models on physiological and neurophysiological measures of the pain experience and compare the recovery profile of each group.
Trial website
Trial related presentations / publications
Public notes
In our initial recruitment and testing for this project (commenced June 2018) we discovered a randomization violation. The team member did not use the randomisation schedule / sealed opaque envelopes as per our protocol. Instead, they just consecutively allocated people in to one group until it was full and then moved on to the next group. Thus, the collection was not randomised. This was not picked up until nearly the full cohort had been tested (November 2018). It was an honest mistake, but rendered the data redundant. We planned to recommence the study in late 2019 / early 2020 but were then delayed in restarting by COVID. Thus, we are recommencing recruitment in 2022.

The data generated by the initial 45 participants will not be included in our analysis as it cannot possibly answer the research question. Therefore, we will recommence recruitment and data collection with a new cohort of participants.

Contacts
Principal investigator
Name 79426 0
Dr Mervyn Travers
Address 79426 0
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 79426 0
Australia
Phone 79426 0
+61 8 9433 0561
Fax 79426 0
Email 79426 0
[email protected]
Contact person for public queries
Name 79427 0
Dr Mervyn Travers
Address 79427 0
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 79427 0
Australia
Phone 79427 0
61 8 9433 0561
Fax 79427 0
Email 79427 0
[email protected]
Contact person for scientific queries
Name 79428 0
Dr Mervyn Travers
Address 79428 0
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 79428 0
Australia
Phone 79428 0
+61 8 9433 0561
Fax 79428 0
Email 79428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented to sharing of the data


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
No additional documents have been identified.