Oldpain2go®: an Exploratory (Pre-Feasibility) Study.

Study Overview
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Brief Summary
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Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?

Detailed Description
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Aims: To collect data to: give an indication of the potential effect size, of any effects, from the oldpain2go® intervention, in people with persistent low back pain. to explore the eligibility criteria, recruitment methods and materials proposed here, for potential use in a future Feasibility study, of the oldpain2go® intervention. To compare demographic characteristics, medical history and outcome measure data of: people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session), with those for whom it is not, people for whom the Oldpain2go® intervention works, after one treatment, with those for whom it does not, and people for whom the Oldpain2go® intervention works, after one, or two, treatments, with those for whom it does not work after two treatments.

Official Title
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Oldpain2go®: an Exploratory (Pre-Feasibility) Study.

Conditions
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Pain, Chronic

Intervention / Treatment
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* Other: Oldpain2go®
* Other: Routine low back pain management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently suffering from persistent, non-specific, low back pain Aged over 18 years For whom Oldpain2go® is indicated as a treatment option after the standard clinical screening process for the Oldpain2go® treatment Exclusion Criteria: Any Red Flags, Any causative (or potentially causative) structural abnormality, or pathology detected or suspected Any concurrent pathology, or condition that would limit options for Physiotherapy treatment, Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oldpain2go®<br>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. | Other: Oldpain2go®<br>* This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs such as chronic pain that are troubling them.<br>|
| Active Comparator: Routine low back pain management<br>Normal accepted physiotherapy treatment for persistent low back pain. | Other: Routine low back pain management<br>* Standard low back persistent physiotherapy management as recommended by national guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain | A self reported pain level scale | Change measures at three points, baseline, 1 week and 2 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Roland Morris Disability Questionnaire (RMDQ) | A measure of disability | Change measures at three points, baseline, 1 week and 2 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oldpain2go®, Feasibility