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

NCT03804567 | Completed

• 1 other identifier: 163/18
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Chronic

Keywords

Oldpain2go®; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Roland Morris Disability Questionnaire (RMDQ)

  Change measures at three points, baseline, 1 week and 2 weeks from baseline

Study Arms (2)

Oldpain2go®

EXPERIMENTAL

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®

Routine low back pain management

ACTIVE COMPARATOR

Normal accepted physiotherapy treatment for persistent low back pain.

Other: Routine low back pain management

Interventions

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.

Oldpain2go®

Routine low back pain management OTHER

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

Routine low back pain management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teesside University: lead

Study Sites (1)

Norton Physiotherapy Centre

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

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alasdair MacSween, Dr

  Teesside University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Lecturer in Research Governance

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 16, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

GB (1)