Preventive MedicineNCT05450263
Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain
A study testing Interoceptive exposure in people with Preventive Medicine, run by Orton Orthopaedic Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preventive Medicine
- What is being tested?
- Interoceptive exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 15 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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).
- Conditions
- Preventive Medicine
- Being tested
- Interoceptive exposure
- Keywords
- prevention, sub-acute, low back pain, interoceptive
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive exposureBehavioural
A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Interoceptive exposure |
| Sub-acute low back pain passive intervention | Sham comparator | Control group, treatment as usual. Receives: Behavioral: Interoceptive exposure |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months
Secondary outcomes (2)
Anxiety change
Anxiety symptoms are measured by State-Trait Anxiety Inventory (STAI)
Measured: 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
Measured: Depression at the beginning of the intervention and depression change at 3 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start15 Sep 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: We were unable to recruit participants for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preventive MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orton Orthopaedic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Ristolainen, Orton Orthopaedic Hospital
- Investigators
- Tage Orenius, Principal investigator, Orton Orthopaedic Hospitla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450263
- Sponsor's protocol ID
- Research Institute Orton
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37856182
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05450263
- Acronym / sponsor ID
- Research Institute Orton
- Conditions
- Preventive Medicine
- Keywords
- prevention, sub-acute, low back pain, interoceptive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to recruit participants for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Orton Orthopaedic HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub-acute low back pain active intervention | Active comparator | Behavioral: Interoceptive exposureTo 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 | Behavioral: Interoceptive exposureControl group, treatment as usual. |
| No intervention | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive exposureA pilot study addressing the efficacy and feasibility of an interoceptive exposure technique. | Behavioural | Sub-acute low back pain active intervention, Sub-acute low back pain passive intervention |
Primary outcome
Pain intensity change
Time frame: Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months
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
2 secondary outcomes
Anxiety change
Time frame: Anxiety at the beginning of the intervention and anxiety change at 3 months and 12 months.
Depression change
Time frame: Depression at the beginning of the intervention and depression change at 3 months and 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 37856182Orenius 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tage Orenius principal investigator
Orton Orthopaedic Hospitla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive exposure in people with Preventive Medicine, run by Orton Orthopaedic Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity change (time frame: Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.