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

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ClinicalTrials.gov Identifier: NCT03804567
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Alasdair MacSween, Teesside University

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

Condition or disease Intervention/treatment Phase
Pain, Chronic Other: Oldpain2go® Other: Routine low back pain management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Cormac Ryan, Dr 01642 342965 c.ryan@tees.ac.uk
Contact: Denis G Martin, Professor d.martin@tees.ac.uk

Locations
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United Kingdom
Norton Physiotherapy Centre Recruiting
Norton, Stockton-on-Tees, United Kingdom, TS20 2PT
Contact: Alasdair MacSween, Ph.D    0164234 ext 2965    a.macsween@tees.ac.uk   
Contact: Cormac Ryan, Ph.D    0164234 ext 8253    c.ryan@tees.ac.uk   
Sponsors and Collaborators
Teesside University
Investigators
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Principal Investigator: Alasdair MacSween, Dr Teesside University

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Responsible Party: Alasdair MacSween, Principal Lecturer in Research Governance, Teesside University
ClinicalTrials.gov Identifier: NCT03804567     History of Changes
Other Study ID Numbers: 163/18
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alasdair MacSween, Teesside University:
Oldpain2go®
Feasibility

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms