Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain

Not Applicable

• Conditions: Chronic Low Back Pain
• Interventions: Device: Pulsed Shortwave Therapy; Device: Placebo Pulsed Shortwave Therapy

• Registration Number: NCT03828864
• Lead Sponsor: BioElectronics Corporation

Brief Summary

This study aims to test the efficacy of the ActiPatch® device by means of a randomized double blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.

Detailed Description

This study aims to test the efficacy of the ActiPatch® device by means of a randomised double blind controlled trial in a convenience sample of chronic low back pain patients at Royal Prince Alfred Hospital (RPAH) pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-02-01
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-05
• Primary Completion: 2020-02-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the trial.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Male or female ages 18 or above with stable chronic lower back pain
• Females of childbearing must be on birth control or practice abstinence during the study period.
• In the event of possible pre-existing pregnancy, women of childbearing age will be screened with a urine pregnancy test. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
• ≥3 months duration of chronic low back pain i.e. cut off period for acute pain
• a current BPI pain rating ≥5/10 on one of the 4 of the four pain VAS scales on the BPI
• Most of the pain in the body is present in the lower back or buttock, NOT in the lower extremities, as determined during screening by the principal investigator. The investigator will verbally ask the participant if most of the pain being experienced is in the lower back/buttock area, and rely on the response for inclusion into the study.
• Able to complete and tolerate treatment for the study period.
• Pain stable in one area of the low back- i.e. not variable in location
• Medication regime stable over the last 3 months

Exclusion Criteria

• Female participant who is pregnant.
• Subjects using personal home based electrical stimulation devices
• Prior home use of pulsed shortwave therapy. i.e ActiPatch®
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Planned or scheduled variation in pain related medication (analgesic or psychoactive) regime during the course of the trial.
• Active psychiatric disorders (e.g. participants using antipsychotic medication, with bipolar disorder or schizophrenia).
• Subjects with other concomitant illnesses (e.g., malignancy) which, in the opinion of the investigator, would preclude successful subject participation
• Subjects diagnosed with a history of significant mood disorder will be excluded (Note that subjects with depression or anxiety with adequate control would be acceptable). Participants would be required to be stable with their moods (EPPOC data or psychological or psychiatric evaluation can be referenced in the case of doubt)
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational product in the past 12 weeks
• Participants who are planning to change any other variables during the study period likely to affect their pain or function e.g. commencement of an exercise class; ceasing allied health treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Pulsed Shortwave therapy	Pulsed Shortwave Therapy	Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.
Placebo Pulsed Shortwave therapy	Placebo Pulsed Shortwave Therapy	Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI) Short Form	30 days	The BPI-SF is a questionnaire - self-administered or by interview - that assesses both pain intensity and pain interference in common aspects of one's life. It has reliability \& validity across cultural and language groups \& is one of the standard measures used by the national Electronic Persistent Pain Outcomes Collaboration (ePPOC) that collates data from various Pain Management Centres to evaluate outcomes in pain clinics Australia wide.; Scoring; Question answers are complied into two categories: 1. Pain severity is 0 - 10, with 10 being worst pain possible; 2. Pain inference score is 0 - 10, with 10 being worst possible pain inference

Secondary Outcome Measures

Name	Time	Method
Central Sensitisation Inventory - short form (CSI-9)	30 days	Central Sensitisation (CS) is thought to be one underlying mechanism for the prevalence of chronic pain and the ActiPatch® device is believed to reduce central sensitization. Use of the CSI-9 will be used to assess the extent to which central sensitization is present in the study cohort and if use of the device produces a change in CS. This will then allow appraisal of the role of central sensitization in any outcomes achieved.; Scoring, scores are totaled from the assessment Five severity levels (subclinical = 0-29, mild = 30-39, moderate = 40-49, severe = 50-59, and severe = 60-100) central sensitization
Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance	30 days	The interaction between sleep disturbance and chronic pain is widely reported in the literature, and is thought to be a two way interaction. Use of the PSQ-3 will be used to assess the extent to which perceived sleep disturbance is present in the study cohort and if use of the ActiPatch® device is associated with a change in sleep quality. Addressing sleep quality may help to treat chronic pain including LBP and thereby have clinical treatment applications.; Scoring 0-30, 0 no sleep disturbance and 30 worst sleep disturbance Three visual analog scales of 0-10