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Photobiomodulation for Fatigue, Depression and Pain in Youth with Inflammatory Bowel Disease

Pilot Single Arm Feasibility Study of Photobiomodulation for Fatigue, Depression and Pain in Youth with Inflammatory Bowel Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000602729
Acronym
PBMIBD
Enrollment
8
Registered
2022-04-22
Start date
2023-02-07
Completion date
2024-02-01
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Inflammatory Bowel Disease (IBD) is a chronic, immune-mediated disease of the gastrointestinal tract with frequent extraintestinal involvement and high levels of fatigue, depression and abdominal and musculoskeletal pain. There are currently limited treatment options for fatigue in IBD, despite its significant impact on quality of life and disease burden. Similarly, although depression associated with IBD can be treated with antidepressant medication and psychological therapy, there is a paucity of alternative treatments for those who are unable or unwilling to take antidepressants or engage in psychological therapy. There are also limited treatments available for pain in IBD and many pain medications are contraindicated or poorly tolerated by individuals with IBD due to their impact on gastrointestinal tract. Peak age of IBD onset is during young adulthood and youth with IBD are particularly vulnerable to the effects of fatigue, depression and pain as they are individuating and developing a sense of self, and negotiating relationships. Photobiomodulation (PBM) is a novel treatment involving the use of laser-generated low-powered light therapy which has shown emerging evidence for improving fatigue, depression and pain in both healthy populations and those with chronic illness. Objectives The study aims to assess feasibility, acceptability and preliminary efficacy of photobiomodulation in treatment of fatigue in youth with IBD. It will also assess change in in depression and pain, quality of life, inflammatory markers and microbiome profile, physical activity and physical functioning in response to photobiomodulation. Stdy hypothesis is that PBMt will be feasible and effective in reducing fatigue, depression, pain and inflammatory burden in youth with IBD.

Interventions

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 bee

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).

Sponsors

Tatjana Ewais
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026