Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain
Primary Purpose
Preventive Medicine
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Interoceptive exposure
Sponsored by
About this trial
This is an interventional prevention trial for Preventive Medicine focused on measuring prevention, sub-acute, low back pain, interoceptive
Eligibility Criteria
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)
Sites / Locations
- Orton Orthopaedic HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Sub-acute low back pain active intervention
Sub-acute low back pain passive intervention
No intervention
Arm 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)
Control group, treatment as usual.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Anxiety change
Anxiety symptoms are measured by State-Trait Anxiety Inventory (STAI)
Depression change
Depression is measured by Beck Depression Inventory (BDI), version II
Full Information
NCT ID
NCT05450263
First Posted
June 22, 2022
Last Updated
September 26, 2022
Sponsor
Orton Orthopaedic Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05450263
Brief Title
Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orton Orthopaedic Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
A pilot study (n=7+7) to address the efficacy and feasibility of IET in preventing chronicity of sub-acute pain
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventive Medicine
Keywords
prevention, sub-acute, low back pain, interoceptive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sub-acute low back pain active intervention
Arm Type
Active Comparator
Arm 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)
Arm Title
Sub-acute low back pain passive intervention
Arm Type
Sham Comparator
Arm Description
Control group, treatment as usual.
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Interoceptive exposure
Intervention Description
A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.
Primary Outcome Measure Information:
Title
Pain intensity change
Description
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
Time Frame
Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months
Secondary Outcome Measure Information:
Title
Anxiety change
Description
Anxiety symptoms are measured by State-Trait Anxiety Inventory (STAI)
Time Frame
Anxiety at the beginning of the intervention and anxiety change at 3 months and 12 months.
Title
Depression change
Description
Depression is measured by Beck Depression Inventory (BDI), version II
Time Frame
Depression at the beginning of the intervention and depression change at 3 months and 12 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tage Orenius
Phone
+358505223780
Email
tage.orenius@orton.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Leena Ristolainen
Phone
+358406312255
Email
leena.ristolainen@orton.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tage Orenius
Organizational Affiliation
Orton Orthopaedic Hospitla
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orton Orthopaedic Hospital
City
Helsinki
ZIP/Postal Code
00280
Country
Finland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain
We'll reach out to this number within 24 hrs