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Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain

Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain - a Pilot Study Addressing the Efficacy and Feasibility of an Interoceptive Exposure Technique.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05450263
Enrollment
0
Registered
2022-07-08
Start date
2022-09-15
Completion date
2024-12-31
Last updated
2025-04-13

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

Conditions

Preventive Medicine

Keywords

prevention, sub-acute, low back pain, interoceptive

Brief summary

Aim of the study It could be stated that chronification of low back pain in some respects depends on the emotional reactions to the acute pain state. This approach enables advancing novel therapeutics for preventing pain chronification by altering the pain-related affective states. At present, no publication evaluating the efficacy of IET in altering brain responses related to sub-acute low back pain seems available. Neither have we found any studies specifically addressing the efficacy of mindfulness training on the functional connection between PFC and NAc. The aim of this study project is three-fold: 1. A systematic literature review of behavioural methods in the prevention of low back pain chronicity Orenius T, Silén E, Nuortimo A, Ristolainen L. Psychological interventions in preventing chronicity of sub-acute back pain: a systematic review. Scand J Pain. 2022 Jan 24;22(2):211-217. doi: 10.1515/sjpain-2021-0063. PROSPERO: CRD42019053580 2. A pilot study (n=7+7) to address the efficacy and feasibility of IET in preventing chronicity of sub-acute pain 3. A full scale study (n=20+20) addressing the efficacy and feasibility of IET in the prevention of chronicity of sub-acute low back pain

Detailed description

To assess the efficacy of IET on the chronification of LBP, participants who are found to have a higher risk of pain chronification due to the presence of a biomarker (positive mPFC-Nac connectivity) will be randomized to the intervention group (IET) or control group A (treatment as usual). To assess how well this biomarker predicts the chronification of LBP, participants who are not found to have the biomarker will be assigned to control group B (treatment as usual).

Interventions

A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.

Sponsors

Orton Orthopaedic Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

The selection of subjects will meet same criteria as in the study by Baliki et al. (2010). * Low back pain diagnosed by a clinician * Low back pain intensity \> 40/100 on NRS * Low back pain duration 4-12 weeks

Exclusion criteria

* Other chronic painful condition * Systemic disease * History of head injury * Diagnosed psychiatric disorders * Depression exceeding mild depression (score \> 19), as defined by Beck's Depression Inventory (BDI)

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity changePain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 monthsMeasured by numeric rating scale (NRS) with a pain intensity ranging from no pain to worst pain (1 to 10) according to the conventional use of NRS

Secondary

MeasureTime frameDescription
Anxiety changeAnxiety at the beginning of the intervention and anxiety change at 3 months and 12 months.Anxiety symptoms are measured by State-Trait Anxiety Inventory (STAI)
Depression changeDepression at the beginning of the intervention and depression change at 3 months and 12 months.Depression is measured by Beck Depression Inventory (BDI), version II

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026