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We were unable to recruit participants for this study.
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-acute low back pain active intervention | Active Comparator | 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) |
|
| Sub-acute low back pain passive intervention | Sham Comparator | Control group, treatment as usual. |
|
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interoceptive exposure | Behavioral | A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity change | Measured 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 | Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety change | Anxiety symptoms are measured by State-Trait Anxiety Inventory (STAI) | Anxiety at the beginning of the intervention and anxiety change at 3 months and 12 months. |
| Depression change |
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Inclusion Criteria:
The selection of subjects will meet same criteria as in the study by Baliki et al. (2010).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tage Orenius | Orton Orthopaedic Hospitla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orton Orthopaedic Hospital | Helsinki | 00280 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37856182 | Derived | Orenius TI, Ristolainen L, Silen E, Hurri H. The Efficacy and Feasibility of an Interoceptive Exposure Technique for Preventing the Transition From Subacute to Chronic Back Pain by Altering the Emotional Response to Pain: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 19;12:e45701. doi: 10.2196/45701. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Depression is measured by Beck Depression Inventory (BDI), version II
| Depression at the beginning of the intervention and depression change at 3 months and 12 months. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |