Low Back PainRESETNCT06218459
A Comparison of Two Brief Interventions for People With Chronic Low Back Pain
A study testing Oldpain2go® and Jacobson's progressive relaxation in people with Low Back Pain, run by Teesside University at 1 site in United Kingdom.
Trial summary
The goal is to undertake a Decentralized Randomized Pilot Feasibility study to inform the methods for a definitive Randomized Controlled Trial (RCT) (including recruitment success, participant experience, intervention delivery, safety, outcome measurement and sample size estimation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Oldpain2go® and Jacobson's progressive relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2024to 31 Aug 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently suffering from persistent, non-specific, low back pain of six or more months duration
- No known tissue damage, structural abnormality, or pathology causing persistent low back pain
- Aged over 18 years
- Person's for whom Oldpain2go® is indicated as a treatment option, after the standard clinical screening process for the Oldpain2go® treatment
- Has access to digital communication device able to host encrypted secure on-line meetings.
Who cannot join
- Any Red Flags,
- Any causative (or potentially causative) structural abnormality, or pathology detected or suspected
- Any concurrent pathology, or condition that would render them unsuitable for on-line virtual assessment and Physiotherapy treatment
- Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norton Physiotherapy Centre
Norton, Stockton-on-Tees, TS20 2PT
About this study
Official title: Oldpain2go®: a Randomized Pilot Virtual Feasibility Study for a Virtual Randomized Control Trial of a Novel Brief Intervention for People With Chronic Low Back Pain: RESET
The goal is to undertake a Decentralized Randomized Pilot Feasibility study to inform the methods for a definitive Randomized Controlled Trial (RCT) (including recruitment success, participant experience, intervention delivery, safety, outcome measurement and sample size estimation). The main question is if the methods used are feasible for an adequately powered future RCT. Participants will be randomly allocated to receive either: Intervention - OldPain2Go® treatment or Placebo Control - Jacobson's progressive relaxation
Read the detailed description
The project is a virtual Randomized Control Trial and the independent variable is OldPain2Go® a novel brief intervention for people with chronic low back pain. The investigators aim to answer the research question: Is OldPain2Go® an effective intervention for pain and function in people with chronic low back pain - when applied in an adequately powered RCT comparing OldPain2Go® with placebo? The Intervention arm participants will receive OldPain2Go® and the Control arm participants will receive Jacobson's progressive relaxation, as a placebo. The Control (placebo) is a commonly used element of treatment, for a wide range of conditions, but is never applied only once (or twice) as a treatment.
- Conditions
- Low Back Pain
- Being tested
- Oldpain2go®, Jacobson's progressive relaxation
- Keywords
- Chronic Pain, Feasibility Study
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oldpain2go®Other
OldPain2Go® is a non-medical intervention for the treatment of chronic pain conditions including, but not limited to Chronic Low Back Pain. The underlying premise is rooted in the biopsychosocial model of pain, where the cause of ongoing pain and the development of chronicity, is believed to lie beyond simple tissue damage, injury or malfunction. The intervention draws upon subconscious communication as a means to help patients to re-frame their pain as less threatening and remove old, out of date, pain messages that no longer serve a purpose.
Jacobson's progressive relaxationOther
Jacobson's progressive relaxation is a technique commonly used for eliciting the relaxation response and relieving muscular tension. It involves sequentially relaxing various muscle groups, often starting at the head and moving down the body to the feet.
| Study group | Role | What they receive |
|---|---|---|
| Oldpain2go® | Experimental | This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs (chronic pain) that are troubling them. Receives: Other: Oldpain2go® |
| Jacobson's progressive relaxation | Placebo comparator | Jacobson's progressive relaxation is used in a range of conditions to relieve muscle tension and stress as part of self-management. Receives: Other: Jacobson's progressive relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-10 Numeric Rating Scale for Pain Intensity
A standard measure in most pain studies. Participants are asked to rate their pain on a 0-10 scale with 0 being no pain and 10 being worst imaginable pain.
A higher score means greater pain. An increase in score, over time, means an increase in pain and a worse outcome.
Measured: Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.
The Roland Morris Disability Questionnaire
A standard measure used in most low back pain studies to measure the degree of a person's disability. It is a 24 item, closed question, self-completed questionnaire. Each item is scored as zero or one and the minimum score is zero and maximum is 24.
A higher score means greater self-rated physical disability caused by low back pain. An increase in score, over time, means an increase in self-rated physical disability caused by low back pain and a worse outcome.
Measured: Change measures at five time points, baseline, 1 week and 2, 4 and 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 May 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Why it stopped: Failed to recruit to target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential randomised assignment to intervention or control arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Norton Physiotherapy, Newcastle University
- Responsible party
- Principal investigator, Alasdair MacSween, Teesside University
- Investigators
- Alasdair MacSween, PhD, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218459
- Sponsor's protocol ID
- RESET 2023 Dec 17639 Macsween
- Acronym
- RESET
- Status last verified
- Sep 2025
- First submitted
- 10 Jan 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-person identifiable data set (non-person identifiable demographics and outcome measure data) will be available on as an Excel Spreadsheet on Teesside University's Mendeley Data account and will be accessible to all under Attribution 4.0 International (CC BY 4.0) licence.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oldpain2go®: a Randomized Pilot Virtual Feasibility Study for a Virtual Randomized Control Trial of a Novel Brief Intervention for People With Chronic Low Back Pain: RESET
- ClinicalTrials.gov ID
- NCT06218459
- Acronym / sponsor ID
- RESET / RESET 2023 Dec 17639 Macsween
- Conditions
- Low Back Pain
- Keywords
- Chronic Pain, Feasibility Study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to recruit to target.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Norton Physiotherapy, Newcastle University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 23 Jan 2024 (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.
The goal is to undertake a Decentralized Randomized Pilot Feasibility study to inform the methods for a definitive Randomized Controlled Trial (RCT) (including recruitment success, participant experience, intervention delivery, safety, outcome measurement and sample size estimation). The main question is if the methods used are feasible for an adequately powered future RCT. Participants will be randomly allocated to receive either: Intervention - OldPain2Go® treatment or Placebo Control - Jacobson's progressive relaxation
Detailed description
The project is a virtual Randomized Control Trial and the independent variable is OldPain2Go® a novel brief intervention for people with chronic low back pain. The investigators aim to answer the research question: Is OldPain2Go® an effective intervention for pain and function in people with chronic low back pain - when applied in an adequately powered RCT comparing OldPain2Go® with placebo? The Intervention arm participants will receive OldPain2Go® and the Control arm participants will receive Jacobson's progressive relaxation, as a placebo. The Control (placebo) is a commonly used element of treatment, for a wide range of conditions, but is never applied only once (or twice) as a treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential randomised assignment to intervention or control arms.
| Arm | Type | Receives |
|---|---|---|
| Oldpain2go® | Experimental | Other: Oldpain2go®This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs (chronic pain) that are troubling them. |
| Jacobson's progressive relaxation | Placebo comparator | Other: Jacobson's progressive relaxationJacobson's progressive relaxation is used in a range of conditions to relieve muscle tension and stress as part of self-management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently suffering from persistent, non-specific, low back pain of six or more months duration
- No known tissue damage, structural abnormality, or pathology causing persistent low back pain
- Aged over 18 years
- Person's for whom Oldpain2go® is indicated as a treatment option, after the standard clinical screening process for the Oldpain2go® treatment
- Has access to digital communication device able to host encrypted secure on-line meetings.
Key exclusion criteria (4 listed)
- Any Red Flags,
- Any causative (or potentially causative) structural abnormality, or pathology detected or suspected
- Any concurrent pathology, or condition that would render them unsuitable for on-line virtual assessment and Physiotherapy treatment
- Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent
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 |
|---|---|---|
| Oldpain2go®OldPain2Go® is a non-medical intervention for the treatment of chronic pain conditions including, but not limited to Chronic Low Back Pain. The underlying premise is rooted in the biopsychosocial model of pain, where the cause of ongoing pain and the development of chronicity, is believed to lie beyond simple tissue damage, injury or malfunction. The intervention draws upon subconscious communication as a means to help patients to re-frame their pain as less threatening and remove old, out of date, pain messages that no longer serve a purpose. | Other | Oldpain2go® |
| Jacobson's progressive relaxationJacobson's progressive relaxation is a technique commonly used for eliciting the relaxation response and relieving muscular tension. It involves sequentially relaxing various muscle groups, often starting at the head and moving down the body to the feet. | Other | Jacobson's progressive relaxation |
Primary outcome
0-10 Numeric Rating Scale for Pain Intensity
Time frame: Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.
A standard measure in most pain studies. Participants are asked to rate their pain on a 0-10 scale with 0 being no pain and 10 being worst imaginable pain. A higher score means greater pain. An increase in score, over time, means an increase in pain and a worse outcome.
The Roland Morris Disability Questionnaire
Time frame: Change measures at five time points, baseline, 1 week and 2, 4 and 12 weeks from baseline
A standard measure used in most low back pain studies to measure the degree of a person's disability. It is a 24 item, closed question, self-completed questionnaire. Each item is scored as zero or one and the minimum score is zero and maximum is 24. A higher score means greater self-rated physical disability caused by low back pain. An increase in score, over time, means an increase in self-rated physical disability caused by low back pain and a worse outcome.
Results and safety
The study was stopped early (reason given: Failed to recruit to target.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. The non-person identifiable data set (non-person identifiable demographics and outcome measure data) will be available on as an Excel Spreadsheet on Teesside University's Mendeley Data account and will be accessible to all under Attribution 4.0 International (CC BY 4.0) licence.
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Alasdair MacSween, PhD principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oldpain2go® and Jacobson's progressive relaxation in people with Low Back Pain, run by Teesside University at 1 site in United Kingdom.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Sep 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 United Kingdom. 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 stopped early (reason given: Failed to recruit to target.). Results are not available in the source record.
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?
0-10 Numeric Rating Scale for Pain Intensity (time frame: Change measures at six time points, baseline, immediately after treatment, 1 week and 2, 4 and 12 weeks from baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.