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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
Teesside University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Oldpain2go®, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 11, 2019
Last Updated
April 9, 2020
Sponsor
Teesside University
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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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