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

April 9, 2020 updated by: Alasdair MacSween, Teesside University
Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aims:

  1. To collect data to:

    1. give an indication of the potential effect size, of any effects, from the oldpain2go® intervention, in people with persistent low back pain.
    2. to explore the eligibility criteria, recruitment methods and materials proposed here, for potential use in a future Feasibility study, of the oldpain2go® intervention.

  2. To compare demographic characteristics, medical history and outcome measure data of:

    1. people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session), with those for whom it is not,
    2. people for whom the Oldpain2go® intervention works, after one treatment, with those for whom it does not, and
    3. 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

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Stockton-on-Tees
      • Norton, Stockton-on-Tees, United Kingdom, TS20 2PT
        • Norton Physiotherapy Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Change measures at three points, baseline, 1 week and 2 weeks from baseline
A measure of disability
Change measures at three points, baseline, 1 week and 2 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teesside University

Investigators

  • Principal Investigator: Alasdair MacSween, Dr, Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 163/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Chronic

Clinical Trials on Oldpain2go®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe