Oldpain2go®: an Exploratory (Pre-Feasibility) Study. (Oldpain2go®)
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oldpain2go®
Routine low back pain management
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic focused on measuring Oldpain2go®, Feasibility
Eligibility Criteria
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
Sites / Locations
- Norton Physiotherapy Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oldpain2go®
Routine low back pain management
Arm Description
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.
Normal accepted physiotherapy treatment for persistent low back pain.
Outcomes
Primary Outcome Measures
A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain
A self reported pain level scale
Secondary Outcome Measures
The Roland Morris Disability Questionnaire (RMDQ)
A measure of disability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03804567
Brief Title
Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
Acronym
Oldpain2go®
Official Title
Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teesside University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Oldpain2go®, Feasibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oldpain2go®
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine low back pain management
Arm Type
Active Comparator
Arm Description
Normal accepted physiotherapy treatment for persistent low back pain.
Intervention Type
Other
Intervention Name(s)
Oldpain2go®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine low back pain management
Intervention Description
Standard low back persistent physiotherapy management as recommended by national guidelines.
Primary Outcome Measure Information:
Title
A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain
Description
A self reported pain level scale
Time Frame
Change measures at three points, baseline, 1 week and 2 weeks from baseline
Secondary Outcome Measure Information:
Title
The Roland Morris Disability Questionnaire (RMDQ)
Description
A measure of disability
Time Frame
Change measures at three points, baseline, 1 week and 2 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alasdair MacSween, Dr
Organizational Affiliation
Teesside University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Physiotherapy Centre
City
Norton
State/Province
Stockton-on-Tees
ZIP/Postal Code
TS20 2PT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
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