Clinical trial NCT05450263: Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preventive Medicine
Keywords: prevention
sub-acute
low back pain
interoceptive
Lead sponsor: Orton Orthopaedic Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Pain intensity change
timeFrame: Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months
Secondary outcomes:
measure: Anxiety change
timeFrame: Anxiety at the beginning of the intervention and anxiety change at 3 months and 12 months.
measure: Depression change
timeFrame: Depression at the beginning of the intervention and depression change at 3 months and 12 months.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Orton Orthopaedic Hospital
Study officials:
affiliation: Orton Orthopaedic Hospitla
name: Tage Orenius
role: PRINCIPAL_INVESTIGATOR
References: