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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05450263
Other study ID # Research Institute Orton
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Orton Orthopaedic Hospital
Contact Tage Orenius
Phone +358505223780
Email tage.orenius@orton.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Finland Orton Orthopaedic Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Orton Orthopaedic Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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.
Secondary Depression change 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.
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