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

Chronic Low Back Pain Clinical Trial

— PSWT  

Official title:

Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03828864
• Other study ID #: X18-0425
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: January 2019
• Source: BioElectronics Corporation
• Contact: Graeme Campbell
• Phone: (02) 95159016
• Email: graeme.campbell1[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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®.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: May 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Pulsed Shortwave Therapy
Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
• Placebo Pulsed Shortwave Therapy
Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BioElectronics Corporation	Royal Prince Alfred Hospital, Sydney, Australia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory (BPI) Short Form	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: Pain severity is 0 - 10, with 10 being worst pain possible; Pain inference score is 0 - 10, with 10 being worst possible pain inference	30 days
Secondary	Central Sensitisation Inventory - short form (CSI-9)	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	30 days
Secondary	Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance	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	30 days