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

NCT05450263 | Withdrawn

• 1 other identifier: Research Institute Orton
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 2.A pilot study (n=7+7) to address the efficacy and feasibility of IET in preventing chronicity of sub-acute pain
3. 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

Conditions

Preventive Medicine

Keywords

prevention; sub-acute; low back pain; interoceptive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety change

  Anxiety at the beginning of the intervention and anxiety change at 3 months and 12 months.

• Depression change

  Depression at the beginning of the intervention and depression change at 3 months and 12 months.

Study Arms (3)

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)

Behavioral: Interoceptive exposure

Sub-acute low back pain passive intervention

SHAM COMPARATOR

Control group, treatment as usual.

Behavioral: Interoceptive exposure

No intervention

NO INTERVENTION

Interventions

Interoceptive exposure BEHAVIORAL

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

Sub-acute low back pain active intervention; Sub-acute low back pain passive intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Orton Orthopaedic Hospital: lead

Study Sites (1)

Orton Orthopaedic Hospital

Helsinki, 00280, Finland

Location

Related Publications (1)

• 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.

  PMID: 37856182 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tage Orenius

  Orton Orthopaedic Hospitla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tage Orenius, Clinical psychologist, Principal Investigatior, tage.orenius@orton.fi, Leena Ristolainen as a co-author. This registration was submitted together with Tage Orenius

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 8, 2022
• Study Start: September 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)