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

Pain, Chronic Clinical Trial

— Oldpain2go®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804567
• Other study ID #: 163/18
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: April 2020
• Source: Teesside University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Norton Physiotherapy Centre	Norton	Stockton-on-Tees

Sponsors (1)

Lead Sponsor	Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain	A self reported pain level scale	Change measures at three points, baseline, 1 week and 2 weeks from baseline
Secondary	The Roland Morris Disability Questionnaire (RMDQ)	A measure of disability	Change measures at three points, baseline, 1 week and 2 weeks from baseline