Skip to content

Why does pain spread? Using touch to treat the spread of pain

Why does pain spread? An investigation of inhibition in the human brain in adults with chronic back pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001379808
Enrollment
20
Registered
2021-10-11
Start date
2022-04-13
Completion date
2023-04-03
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite enormous personal and economic cost, chronic (i.e. persistent) pain is too often overlooked. One feature of pain we particularly do not understand is its spread. We hypothesise that the spread of pain reflects an impairment in the way the brain processes incoming sensory information. We will trial a non-invasive tactile (touch) training program, to reduce pain spread in adults with chronic back pain. Crucially - in one of the only longitudinal brain imaging investigations to date - we will scan with electroencephalography (EEG), functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS) before and after training so we can better understand the mechanisms of the training and thus more fully harness the potential of this novel idea. We anticipate that the tactile training program, which involves discriminating non-painful two-point stimuli, with feedback, will reduce the spread of pain and will improve tactile function (often poor in chronic pain disorders). Further, we hypothesise that the tactile outcomes will be associated with the EEG and MRI/S outcomes.

Interventions

Scan sessions (Electroencephalography, EEG, and Magnetic Resonance Imaging, MRI, and Magnetic Resonance Spectroscopy, MRS) will be conducted before and after the intervention in participants who are eligible and safe for neuroimaging. The scan sessions, where possible, will be conducted within a short time frame (or at least the second scanning session will, where possible, be conducted within approximately a week of training completion), in order to maximise chances of a positive training effec

Scan sessions (Electroencephalography, EEG, and Magnetic Resonance Imaging, MRI, and Magnetic Resonance Spectroscopy, MRS) will be conducted before and after the intervention in participants who are eligible and safe for neuroimaging. The scan sessions, where possible, will be conducted within a short time frame (or at least the second scanning session will, where possible, be conducted within approximately a week of training completion), in order to maximise chances of a positive training effect on pain (and detection of its effects with neuroimaging). The scan sessions will be used to explore brain activity (EEG and functional MRI) and neurochemistry (MRS) - and their relationship - before and after the intervention. EEG sessions will last a duration of approximately 45 minutes. The EEG sessions will occur at a University research laboratory at Curtin University, in a dedicated quiet room and will be conducted by a trained Research Assistant. MRI/S sessions will last a duration of approximately 1 hour and will be conducted at Perth Radiological Clinic, a private radiological clinic. The neuroimaging assessment provides an insight into the neural mechanisms that might be responsible for the hypothesised reduction in pain with our intervention - a tactile training program. The tactile training program is a two point discrimination (TPD) training program, consisting of stages, that has been designed specifically for this study. Participants will be randomly assigned to either the intervention group or the control group. In all instances the training will be completed by either the trial CI or the trained Research Assistant (both are registered physiotherapists). The location will be a quiet area - mutually convenient for the researcher and the participant. The training sessions will be of a duration of approximately one hour. Participants will attend up to 3 training sessions per week. They will attend a minimum of 2 sessions in a 'stage' (below). A maximum of 8 TPD training sessions will be conducted (10 total, when including the TPD training in the Scan Sessions). The intervention involves TPD training at locations remote from the participant's pain, or locations adjacent to their pain, or at the site of pain. TPD is defined as the shortest distance between two points on the skin that someone can recognise as two points, not one, touching the skin. That is, this is a measure of tactile acuity. This task relies heavily on inhibition in the nervous system. Precise callipers will be placed on the skin at the aforementioned sites, and the distance between the callipers will be increased and decreased repeatedly. The participant will state whether one or two points has touched the skin. They will be informed of correct and incorrect responses immediately (i.e. feedback is given). To make the training more motivating and engaging, training will delivered in stages: i.e. participants may also be asked to judge the relative differences between two-point distances as they are placed on the skin, or asked to visually identify and show the researcher the two-point distance they believed they received. All participant responses/judgements will be met with feedback from the researcher. Adherence to the intervention will be monitored by recording the participants’ attendance and intervention results on a data collection form. A pilot study of up to 10 participants will be conducted within three months of commencement of the main RCT. Participants in the pilot study will receive either the intervention or control training programs. The purpose of the pilot study is to familiarise the Research Assistant with procedures and fine-tune the protocols. The data from the pilot study will not be included for analysis. It is not anticipated any changes to the intervention described herein will be made prior to commencing the main RCT.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Participants will be included if they are adults, have chronic non-specific back pain, i.e pain duration of 3 months or more, are fluent in written and verbal English and under the regular care of a General Practitioner (GP).

Exclusion criteria

Potential participants will be excluded if their back pain is not non-specific: i.e. if their pain is primarily visceral in origin; they demonstrate signs or symptoms of nerve root pain; or there is evidence of current specific spinal pathology (eg malignancy, fracture, infection, inflammatory joint or bone disease). We will also exclude potential participants if they are pregnant or less than 6 months post-partum, if they have undergone recent spinal surgery, or if they have a significant mental health disorder or a health impairment that would interfere with their safe participation and adherence to study requirements. Each participant will complete safety screening questionnaires prior to the MRS and the EEG assessments. Participants will be excluded from these assessments if they do not meet the required safety criteria for each.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026