Modulation of chronic pain perception with noninvasive central and peripheral nervous system stimulation.

The effect of transcranial direct current stimulation and transcutaneous electrical nerve stimulation on improving pain intensity, physical functioning, mental health and quality of life in a chronic pain population awaiting pain clinic intervention.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001232729

Enrollment

Registered

2013-11-11

Start date

2013-11-18

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The aims of the randomized controlled research project are to investigate the effects of five consecutive daily sessions (1 x 30 minute session/ treatment day) of both: 1) transcranial direct current stimulation (tDCS) and 2) transcutaneous electrical nerve stimulation (TENS) in improving pain intensity, physical functioning, mental health and quality of life in a chronic pain population awaiting pain clinic intervention. The study also aims to investigate whether prior treatment with consecutive daily sessions of both tDCS and TENS improves the outcomes of pain clinic intervention. Outcome measures and methods that will be used to achieve these aims will include: 1) asking subjects to complete self-reported questionnaires that include questions related to measures of pain, physical function, mental health and quality of life 2) measuring the subject's sensitivity to mechanical, electrical and thermal induced pain stimuli (i.e. the stimulus intensity will be increased until the subject can confidently perceive that the pain elicited by the stimulus ‘matches’ the level of intensity of their current pain problem) delivered to the subject's dominant hand using a pressure algometer, electric current stimulator and thermal stimulus respectively 3) collecting subject's saliva to assess induced changes to pain related biomarkers using immunohistochemical techniques.

Interventions

Intervention group 1: Subjects receive transcranial direct current stimulation and transcutaneous electrical nerve stimulation only: Transcranial direct current stimulation (Chattanooga Ionto, Tennessee, USA). Dose: 2mA Duration: 30min Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over the dominant motor cortex. Transcutaneous electrical nerve stimulation (Comffit T-20). Specification: 10Hz, non-noxious intensity Duration: 30min Mode of administration: 5 consecutive daily sessions (1 session/ treatment day) applied over the bodily site of pain. Transcranial direct current stimulation and transcutaneous electrical nerve stimulation are applied simultaneously during each of the 5 consecutive daily sessions.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

1) aged 18-64, 2) chronic musculo-skeletal pain (>3 months, prediagnosed) 3) awaiting pain clinic intervention at the Gold Coast Interdisciplinary Persistent Pain Centre

Exclusion criteria

Exclusion criteria to be used by the Interdisciplinary Persistent Pain Centre: People with medical acuity score of >20 classed as a category one referal. Exclusion criteria to be used by the coordinating principal researcher: Spinal surgery in the past 6 months, persistent neurological condition, current abuse of elicit substances and alcohol, pregnancy, does not understand English, magnetic/ metallic pieces inside skull, implanted metal devices (Pacemaker, cochlear device, medication pump, nervous system stimulators), cardiac disease, skin lesion near electrode sites, acute musculoskeletal injuries.

Outcome results