Oldpain2go®: an Exploratory (Pre-Feasibility) Study. (Oldpain2go®)
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|ClinicalTrials.gov Identifier: NCT03804567|
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : April 10, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Pain, Chronic||Other: Oldpain2go® Other: Routine low back pain management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oldpain2go®: an Exploratory (Pre-Feasibility) Study.|
|Actual Study Start Date :||January 16, 2019|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
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.
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.
Active Comparator: Routine low back pain management
Normal accepted physiotherapy treatment for persistent low back pain.
Other: Routine low back pain management
Standard low back persistent physiotherapy management as recommended by national guidelines.
- A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain [ Time Frame: Change measures at three points, baseline, 1 week and 2 weeks from baseline ]A self reported pain level scale
- The Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Change measures at three points, baseline, 1 week and 2 weeks from baseline ]A measure of disability
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804567
|Norton Physiotherapy Centre|
|Norton, Stockton-on-Tees, United Kingdom, TS20 2PT|
|Principal Investigator:||Alasdair MacSween, Dr||Teesside University|
|Responsible Party:||Alasdair MacSween, Principal Lecturer in Research Governance, Teesside University|
|Other Study ID Numbers:||
|First Posted:||January 15, 2019 Key Record Dates|
|Last Update Posted:||April 10, 2020|
|Last Verified:||April 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|