Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000602729
Ethics application status
Approved
Date submitted
8/04/2022
Date registered
22/04/2022
Date last updated
17/07/2023
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Photobiomodulation for Fatigue, Depression and Pain in Youth with Inflammatory Bowel Disease
Scientific title
Pilot Single Arm Feasibility Study of Photobiomodulation for Fatigue, Depression and Pain in Youth with Inflammatory Bowel Disease
Secondary ID [1] 292171 0
None
Universal Trial Number (UTN)
U1111-1276-9375
Trial acronym
PBMIBD
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Fatigue 325970 0
Depression 325971 0
Pain 325972 0
Inflammatory Bowel Disease 326037 0
Condition category
Condition code
Oral and Gastrointestinal 323286 323286 0 0
Inflammatory bowel disease
Mental Health 323287 323287 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Photobiomodulation therapy (PBMt) is the use of photonic (light) energy to modulate cellular activity. PBMt has a significant evidence base for modulating not only physiological markers across a range of conditions, but more recently it has been shown to have early promise in influencing neuropsychiatric/neuropsychological effects in a range of conditions that may have similar non-intestinal symptomology to IBD. For physiological effects, as pre-conditioning to an exercise protocol, PBMt has been shown to have moderate evidence for improving markers of physical performance (e.g., exercise capacity and time to exhaustion; and peak muscle torque) and low to moderate evidence for reducing signs of muscle fatigue in healthy subjects but more recently also in people with chronic obstructive pulmonary disease.

Research on the effects of PBM on physical performance has found that PBM significantly reduced muscle fatigue across a range of indicators, with significant differences between PBM and placebo. Taken together, these results suggest that fatigue in chronic disease can be mitigated by using PBM.

Preliminary evidence also exists for the use of PBM in treatment of depression and other psychiatric and neurological conditions. For example, in a review of the literature, Cassano et al identified evidence that PBM was well tolerated by people with depression, and that depressive symptoms could be significantly reduced in people with major depressive disorder. Anti-anxiety and anti-depressive effects have also been demonstrated in a mouse model. In people with Parkinson’s disease, PBMt has been shown to improve sleep-wake cycles.

This study hypothesis is that PBM will reduce fatigue, depression, abdominal and joint pain, and inflammatory burden in youth with IBD.
Hypothesis specific to the pilot nature of the study is that the PBM intervention and study procedures will be feasible and acceptable.

PBMt will be delivered by using the ProSeries device (SYMBYX, Australia) multi-diode 904nm array. PBMt will be applied for approximately 1.5-2 minutes per site, on 9 abdominal sites and 6 anterior thigh sites (3 on each thigh), with the whole PBMt session lasting about 30 minutes.


PBMt will be delivered in weekly one-on-one face-to-face consultations for ten weeks. PBMt will be administered by an experienced physiotherapist-study co-investigator.

Strategies used to monitor adherence to the intervention will include sessions attendance sheet (for PBMt sessions attendance), and participant diary of their weekly exercise (type and duration).
Intervention code [1] 323331 0
Treatment: Devices
Comparator / control treatment
No control group.

This is a prospective, single arm pilot study. Participants will act as their own controls during a 10-week observation period before entering a 10-week PBM treatment phase. A further post-intervention observational period of 10 weeks will assist in determining durability of any effects.

During the 10-week observation period, participants will be asked to record their exercise levels in their study specific diary, and their pain levels (in the study specific diary).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331019 0
fatigue measured using the FACIT-Fatigue questionnaire
Timepoint [1] 331019 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Primary outcome [2] 331020 0
PBM intervention feasibility as indicated by the intervention sessions attendance, recruitment and attrition rates, and participants’ views of the intervention.

PBM intervention feasibility is a composite primary outcome as sessions attendance, recruitment/attrition rates, and participants views of the intervention i.e its acceptability, will together inform whether the PBMt was feasible.

Session attendace will be determined by the attendance checklilst.
Recruitment rate and attrition will be calculated from the study enrolment logs..
Participants view of the intervention i.e its acceptability will be assessed through the post-PBM evaluation questionaire created for the study which contains a mix of closed and open ended questions about participants' view of PBM.
Timepoint [2] 331020 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [1] 408498 0
depression score on Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 408498 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [2] 408499 0
health-related quality of life on Short Form 36 Questionaire (SF-36)
Timepoint [2] 408499 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [3] 408500 0
levels of inflammation (ESR, CRP from the blood samples and fecal calprotectin-FCP from the stool samples);
Timepoint [3] 408500 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [4] 408501 0
physical activity levels measured by the International Physical Activity Questionaire (IPAQ),
Timepoint [4] 408501 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [5] 408502 0
physical function on Patient-specific Functional Scale
Timepoint [5] 408502 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [6] 408503 0
Pain levels by participant self-reports of abdominal and joint pain (by self-report diary).

This is a composite outcome as it will be recorded via the same self-report diary; also some patients will only have abdominal or only joint pain.
Timepoint [6] 408503 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)
Secondary outcome [7] 408504 0
the gut microbiome (by quantity and type of bacterial phyla and genera found in stool samples. These will be assessed as a composite secondary outcome.
Gut microbiome will be assessed by metagenomic sequencing of stool samples.
Timepoint [7] 408504 0
baseline (0 weeks), 10 weeks (post observation period), 20 weeks (post completion of 10-week PBMt, course), 30 weeks (post 10-week washout period)

Eligibility
Key inclusion criteria
- Young adults aged 18-35, with diagnosis of inflammatory bowel disease
- Fatigue symptoms (FACIT F score <30)- Able to verbally communicate and write in English
- Able to give informed consent
- Attending the IBD outpatient clinics at Mater Hospital
- Able to commit to attend the 10 weekly PBM treatment sessions of 30 minutes duration, and further sessions at baseline and the end of the study to complete questionnaires and for collection of blood and stool samples
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prospective participants will be ineligible if they
- have florid psychiatric illness (psychosis, PTSD, substance abuse / dependence) as its treatment and symptoms could interfere with their ability to participate in the programme
- do not have conversational or written English
- are scheduled for major surgery in the next 6 months as this would impact on their ability to attend the programme for its entire duration
- are pregnant, as safety of PBM in pregnancy has not been specifically established

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a repeated measures study, so mixed-effects linear regression modelling will be used to assess the effect of the intervention on continuous outcome measures (depression, anxiety and stress scores, and inflammation levels). We will apply intention-to-treat principles conduct sensitivity analyses, and report proportion of participants lost to follow-up.
In terms of the qualitative data, open ended free text questions from the post-PBM questionnaire will be analysed using thematic analysis and scaled questions will be analysed quantitively.

The sample size will be 24 (taking account of a 5-10% dropout from a total of 28 recruited participants) as this sample size would be able to demonstrate significant difference in the study outcome of fatigue. A sample size of 24 data pairs achieves 80.0% power to reject the null hypothesis of zero effect size when the population effect size is 0.60 and the significance level (alpha) is 0.050 using a two-sided paired t-test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
7/02/2023
Date of last participant enrolment
Anticipated
1/02/2024
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
24
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22153 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 37306 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 296709 0
Charities/Societies/Foundations
Name [1] 296709 0
Mater Foundation
Country [1] 296709 0
Australia
Primary sponsor type
Individual
Name
Tatjana Ewais
Address
level 4, Salmon Building, Mater Young Adult Health Centre,
Raymond Terrace, South Brisbane, Queensland 4101
Country
Australia
Secondary sponsor category [1] 312552 0
None
Name [1] 312552 0
Address [1] 312552 0
Country [1] 312552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297936 0
Mater Misericordiae Ltd Health Research Ethics Committee
Ethics committee address [1] 297936 0
Ethics committee country [1] 297936 0
Australia
Date submitted for ethics approval [1] 297936 0
01/02/2021
Approval date [1] 297936 0
06/12/2021
Ethics approval number [1] 297936 0
HREC/MML/62140 (V3)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75510 0
Dr Tatjana Ewais
Address 75510 0
Mater Young Adult Health Centre, level 4, Salmon Building
Raymond Terrace
South Brisbane
Queensland 4101
Country 75510 0
Australia
Phone 75510 0
+61 7 3163 8521
Fax 75510 0
+61 7 3163 8445
Email 75510 0
[email protected]
Contact person for public queries
Name 75511 0
Liisa Laakso
Address 75511 0
Mater Research
Aubigny Place
Raymond Terrace
South Brisbane Queensland 4101
Country 75511 0
Australia
Phone 75511 0
+61731636964
Fax 75511 0
Email 75511 0
[email protected]
Contact person for scientific queries
Name 75512 0
Tatjana Ewais
Address 75512 0
Mater Young Adult Health Centre, level 4, Salmon Building
Raymond Terrace
South Brisbane
Queensland 4101
Country 75512 0
Australia
Phone 75512 0
+61 7 3163 8521
Fax 75512 0
+61 7 3163 8445
Email 75512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification;
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication;
Available to whom?
only TO researchers who provide a methodologically sound proposal, and at the discretion of Primary Sponsor.
Available for what types of analyses?
to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator who can be contacted via email on [email protected]


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.