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

Teesside University

Status: Completed

Conditions: Pain, Chronic

Treatments: Other: Routine low back pain management; Other: Oldpain2go®

Study type: Interventional

Funder types: Other

Identifiers

NCT03804567

163/18

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Oldpain2go®

Experimental group

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.

Treatment:

Other: Oldpain2go®

Routine low back pain management

Active Comparator group

Description:

Normal accepted physiotherapy treatment for persistent low back pain.

Treatment:

Other: Routine low back pain management