Nociplastic PainPRIME-PRTNCT07287072
Pain Reprocessing Therapy for Chronic Primary Pain
A study testing Pain Reprocessing Therapy in people with Nociplastic Pain and Chronic Primary Pain, run by University of Oslo at 1 site in Norway.
Trial summary
Approximately 30% of adult Norwegians experience chronic pain, with its prevalence rising across demographics, including children and adolescents Chronic pain contributes to significant personal suffering and substantial societal costs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nociplastic Pain, Chronic Primary Pain
- What is being tested?
- Pain Reprocessing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70
- On sick leave, or at risk of sick leave
- Pain intensity corresponding to 3 (or more) on the NRS from the PROMIS-29.
- Readiness to change, corresponding to the action stage from the readiness to change model, where they are ready to participate in their own change process
Who cannot join
- Structural causes for their pain (rheumatoid arthritis, cancer, etc.),
- Severe psychiatric conditions (ongoing or previous psychotic disorders, suicidality, or severe depression/anxiety/bipolar disorder)
- Illegal substance abuse, or known dependence on benzodiazepines or opioids
- Ongoing litigation or compensation process related to the pain condition
- Ongoing and severe psychosocial stressors (e.g. recent divorce etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Reprocessing Therapy for Chronic Primary Pain Caused by a Likely Nociplastic Pain Mechanism in Primary Care: The PRIME-PRT Trial
Approximately 30% of adult Norwegians experience chronic pain, with its prevalence rising across demographics, including children and adolescents Chronic pain contributes to significant personal suffering and substantial societal costs. Traditional treatments - physical, pharmacological, and surgical - as well as psychological interventions, such as cognitive and acceptance-based therapies, demonstrate only minor to modest effects.
To address the challenge of rising demand alongside limited treatment options, university hospitals must consistently evaluate and adopt new, potentially effective therapies to meet their societal mission. Pain Reprocessing Therapy (PRT) is one such innovative treatment that has recently demonstrated promising results for a subset of chronic pain patients in a U.S. primary care setting.
Read more
In this study, the investigators want to assess the effectiveness of PRT on various outcomes in patients with primary chronic pain that has a likely nociplastic pain mechanism, within a Norwegian primary care population.
The insights from this study will be important for any prospective implementation of PRT to align with one of the guiding principles of the Norwegian healthcare system: the Best Effective Level of Care (BEON principle). The BEON principle supports the delivery of high-quality, cost-effective healthcare services and is founded on the notion of seamless integration across different levels of care. When competence or resources at the primary healthcare level are insufficient, more patients tend to be referred to higher, specialized, and inherently more costly levels of care, such as secondary and tertiary care. Therefore, if the study can demonstrate that PRT is effective within a Norwegian primary care population, the hypothesize is that its implementation could strengthen both primary and tertiary care in alignment with the BEON principle.
- Conditions
- Nociplastic Pain, Chronic Primary Pain
- Being tested
- Pain Reprocessing Therapy
- Keywords
- chronic primary pain, Nociplastic pain, Pain Reprocessing Therapy
- Medical subject headings
- Nociplastic Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Reprocessing TherapyBehavioural
Pain Reprocessing Therapy (PRT) has shown promising results for patients with chronic primary back pain with a nociplastic pain-mechanism. PRT consists of two components. The first is an educational component (E) conducted by a physician. The purpose of the educational component is to reorient the patient's understanding of pain in accordance with the theories of nociplastic pain (false alarm based on negative expectations). The second part consists of a set of specific therapeutic techniques (T) that can be performed by a physician, psychologist, or other trained healthcare personnel. The techniques are easy to learn and have a training framework of 50 hours over a period of 3 months. They are based, among other things, on interoceptive exposure techniques, where the main point is to confront internal sensory experiences that have been interpreted as threatening (and ultimately lead to pain), with a new assurance that they do not signal danger ("false alarm").
| Study group | Role | What they receive |
|---|---|---|
| PRT | Experimental | Pain Reprocessing Therapy Receives: Behavioral: Pain Reprocessing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain rating in the past 7 days on a numerical rating scale from 0-10 from Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29)
Pain intensity average last week assessed through one item. The scale ranges from 0 (no pain) to 10 (worst imaginable pain)
Measured: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)
Secondary outcomes (4)
Physical function measured through PROMIS-29
Patient-Reported Outcome Measurement Information System (PROMIS-29) average score post-treatment on the domain Physical function. Scores range from 4-20, with higher scores indicating better function
Measured: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session), 3 monts and at 1 year follow-up
Individual goals assessed through Goal Attainment Scaling (GAS)
Individual goals as defined by the patient. For instance: "Running up a hill" or "playing basketball" (Ref to GAS: Ruble et al., 2012).
Measured: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session), 3 months and at 1 year follow-up
Work participation at 1-year follow-up
Increased work participation since baseline (y/n)
Measured: Assessed through self-report at 5 weeks follow-up and 1 year follow-up
Patient Global Impression of Change
Patients' global impression of change in symptoms, function and quality of life (Hurst, 2004). The scale ranges from 1 (no change) to 7 (a great deal better and considerable improvement)
Measured: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Nociplastic PainStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single Case Experimental Design (SCED). In a SCED study, the unit of analysis is the individual rather than the group, and the patient serves as their own control. Participants will be randomized to different starting periods for the intervention (Phase B) as soon as they are included in the study.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silje Endresen Reme, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287072
- Sponsor's protocol ID
- 884238
- Acronym
- PRIME-PRT
- Status last verified
- May 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators pan to share de-identified individual participant data with collaborating research groups in Sweden and the Netherlands. Access will be restricted to qualified researchers who submit an application and obtain approval from the relevant ethics committee and data protection authority. There is also a plan to share the study protocol, statistical analysis plan, and analysis code.
Publications
Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669.
PubMed 34586357
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reprocessing Therapy for Chronic Primary Pain Caused by a Likely Nociplastic Pain Mechanism in Primary Care: The PRIME-PRT Trial
- ClinicalTrials.gov ID
- NCT07287072
- Acronym / sponsor ID
- PRIME-PRT / 884238
- Conditions
- Nociplastic Pain, Chronic Primary Pain
- Keywords
- chronic primary pain, Nociplastic pain, Pain Reprocessing Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
Approximately 30% of adult Norwegians experience chronic pain, with its prevalence rising across demographics, including children and adolescents Chronic pain contributes to significant personal suffering and substantial societal costs. Traditional treatments - physical, pharmacological, and surgical - as well as psychological interventions, such as cognitive and acceptance-based therapies, demonstrate only minor to modest effects.
To address the challenge of rising demand alongside limited treatment options, university hospitals must consistently evaluate and adopt new, potentially effective therapies to meet their societal mission. Pain Reprocessing Therapy (PRT) is one such innovative treatment that has recently demonstrated promising results for a subset of chronic pain patients in a U.S. primary care setting.
In this study, the investigators want to assess the effectiveness of PRT on various outcomes in patients with primary chronic pain that has a likely nociplastic pain mechanism, within a Norwegian primary care population.
The insights from this study will be important for any prospective implementation of PRT to align with one of the guiding principles of the Norwegian healthcare system: the Best Effective Level of Care (BEON principle). The BEON principle supports the delivery of high-quality, cost-effective healthcare services and is founded on the notion of seamless integration across different levels of care. When competence or resources at the primary healthcare level are insufficient, more patients tend to be referred to higher, specialized, and inherently more costly levels of care, such as secondary and tertiary care. Therefore, if the study can demonstrate that PRT is effective within a Norwegian primary care population, the hypothesize is that its implementation could strengthen both primary and tertiary care in alignment with the BEON principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design (SCED). In a SCED study, the unit of analysis is the individual rather than the group, and the patient serves as their own control. Participants will be randomized to different starting periods for the intervention (Phase B) as soon as they are included in the study.
| Arm | Type | Receives |
|---|---|---|
| PRT | Experimental | Behavioral: Pain Reprocessing TherapyPain Reprocessing Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70
- On sick leave, or at risk of sick leave
- Pain intensity corresponding to 3 (or more) on the NRS from the PROMIS-29.
- Readiness to change, corresponding to the action stage from the readiness to change model, where they are ready to participate in their own change process
Key exclusion criteria (5 listed)
- Structural causes for their pain (rheumatoid arthritis, cancer, etc.),
- Severe psychiatric conditions (ongoing or previous psychotic disorders, suicidality, or severe depression/anxiety/bipolar disorder)
- Illegal substance abuse, or known dependence on benzodiazepines or opioids
- Ongoing litigation or compensation process related to the pain condition
- Ongoing and severe psychosocial stressors (e.g. recent divorce etc.)
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 |
|---|---|---|
| Pain Reprocessing TherapyPain Reprocessing Therapy (PRT) has shown promising results for patients with chronic primary back pain with a nociplastic pain-mechanism. PRT consists of two components. The first is an educational component (E) conducted by a physician. The purpose of the educational component is to reorient the patient's understanding of pain in accordance with the theories of nociplastic pain (false alarm based on negative expectations). The second part consists of a set of specific therapeutic techniques (T) that can be performed by a physician, psychologist, or other trained healthcare personnel. The techniques are easy to learn and have a training framework of 50 hours over a period of 3 months. They are based, among other things, on interoceptive exposure techniques, where the main point is to confront internal sensory experiences that have been interpreted as threatening (and ultimately lead to pain), with a new assurance that they do not signal danger ("false alarm"). | Behavioural | PRT |
Primary outcome
Average pain rating in the past 7 days on a numerical rating scale from 0-10 from Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29)
Time frame: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)
Pain intensity average last week assessed through one item. The scale ranges from 0 (no pain) to 10 (worst imaginable pain)
4 secondary outcomes
Physical function measured through PROMIS-29
Time frame: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session), 3 monts and at 1 year follow-up
Individual goals assessed through Goal Attainment Scaling (GAS)
Time frame: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session), 3 months and at 1 year follow-up
Work participation at 1-year follow-up
Time frame: Assessed through self-report at 5 weeks follow-up and 1 year follow-up
Patient Global Impression of Change
Time frame: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 34586357Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669.
- Individual participant dataSharing planned: Yes. The investigators pan to share de-identified individual participant data with collaborating research groups in Sweden and the Netherlands. Access will be restricted to qualified researchers who submit an application and obtain approval from the relevant ethics committee and data protection authority. There is also a plan to share the study protocol, statistical analysis plan, and analysis code.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Reprocessing Therapy in people with Nociplastic Pain and Chronic Primary Pain, run by University of Oslo at 1 site in Norway.
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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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 Norway. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Average pain rating in the past 7 days on a numerical rating scale from 0-10 from Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) (time frame: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)). 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 NCT07287072, 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 28 May 2026.