Whole-Body Photobiomodulation and Chronic Pain Trial
NCT05069363, Not applicable, Recruiting, Sandwell & West Birmingham Hospitals NHS Trust
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Whole-Body Photobiomodulation and Chronic Pain Trial | ClinicalTrials.gov |
| NCT number | NCT05069363 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sandwell & West Birmingham Hospitals NHS Trust | ClinicalTrials.gov |
| Conditions | Chronic Pain | ClinicalTrials.gov |
| Interventions | Whole-Body Photobiomodulation Therapy | ClinicalTrials.gov |
| First posted | 2021-10-06 | ClinicalTrials.gov |
| Last updated | 2022-06-30 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates | 6 months | Expressed at percentages/proportions | ClinicalTrials.gov |
| Primary | To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates | 6 months | Expressed as percentages/proportions | ClinicalTrials.gov |
| Primary | To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions | 6 months | Participant-reported experience questionnaire (qualitative) | ClinicalTrials.gov |
| Primary | To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions | 6 months | Audio-recorded semi-structured interviews | ClinicalTrials.gov |
| Primary | To assess acceptability of outcome measures | 6 months | Participant-reported experience questionnaire | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Pain: Brief Pain Inventory-Short Form Pain severity - 4xNRS questions (0-40) Interference - 7xNRS questions (0-70) | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Pain: Widespread Pain Index/Symptom Severity Score WPI score 0-19, SSS 0-12. Total out of 31. | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Fatigue: Fatigue Severity Scale 9 x Likert scale questions (1-7). Final score=mean | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Sleep disturbance: Jenkins Sleep Questionnaire 4 x 0-5 questions (total score out of 20) | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Patient global: Patient Global Impression of Change 1-7 | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Multidimensional function: Revised Fibromyalgia Impact Questionnaire (FIQR) 21 x NRS questions (0-100) | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Anxiety and Depression: Hospital Anxiety and Depression Score 7x Likert scale questions (0-3). Total out of 21. | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Tenderness: dolorimeter to apply a set pressure of \<4kg/cm2 to 18 tender points NRS for pain at each point (0-10). MTPS/FIS score total 0 - 180 | ClinicalTrials.gov |
| Primary | Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | 6 months | Dyscognition: Stroop Test (to assess inhibitory control and processing speed) Number of correct answers in 60 seconds. No negative marking | ClinicalTrials.gov |
| Primary | To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial | 6 months | Participant-reported experience questionnaire (qualitative) | ClinicalTrials.gov |
| Primary | To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial | 6 months | Audio-recorded semi-structured interviews | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 35768101 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)