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

Orton Orthopaedic Hospital

Status: Withdrawn

Conditions: Preventive Medicine

Treatments: Behavioral: Interoceptive exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT05450263

Research Institute Orton

Details and patient eligibility

About

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

Full 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).

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Sub-acute low back pain active intervention

Active Comparator group

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)

Treatment:

Behavioral: Interoceptive exposure

Sub-acute low back pain passive intervention

Sham Comparator group

Description:

Control group, treatment as usual.

Treatment:

Behavioral: Interoceptive exposure

No intervention

No Intervention group