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OpenTrials
Completed

NCT Number: NCT03804567

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

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

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norton Physiotherapy Centre

Norton, Stockton-on-Tees, TS20 2PT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oldpain2go®

Other

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.

Routine low back pain management

Other

Standard low back persistent physiotherapy management as recommended by national guidelines.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Teesside University

Other

Registry information

Acronym: Oldpain2go®

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2019
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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