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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Preventive Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sub-acute low back pain active intervention

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)

Group Type ACTIVE_COMPARATOR

Interoceptive exposure

Intervention Type BEHAVIORAL

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

Sub-acute low back pain passive intervention

Control group, treatment as usual.

Group Type SHAM_COMPARATOR

Interoceptive exposure

Intervention Type BEHAVIORAL

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

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interoceptive exposure

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Leena Ristolainen

Tage Orenius, Clinical psychologist, Principal Investigatior, [email protected], Leena Ristolainen as a co-author. This registration was submitted together with Tage Orenius

Responsibility Role PRINCIPAL_INVESTIGATOR