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

Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain - a Pilot Study Addressing the Efficacy and Feasibility of an Interoceptive Exposure Technique.

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

Study Overview

• Status: Recruiting
• Conditions: Preventive Medicine
• Intervention / Treatment: Behavioral: Interoceptive exposure

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tage Orenius; Phone Number: +358505223780; Email: tage.orenius@orton.fi
• Study Contact Backup: Name: Leena Ristolainen; Phone Number: +358406312255; Email: leena.ristolainen@orton.fi

Study Locations

• Finland
  • Helsinki, Finland, 00280
    • Recruiting
    • Orton Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Active Comparator: 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)	Behavioral: Interoceptive exposure; A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.
Sham Comparator: Sub-acute low back pain passive intervention; Control group, treatment as usual.	Behavioral: Interoceptive exposure; A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Orton Orthopaedic Hospital
• Investigators: Principal Investigator: Tage Orenius, Orton Orthopaedic Hospitla

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; prevention; sub-acute; interoceptive
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Research Institute Orton

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No