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

NCT03828864 | Unknown FDA Device

• 1 other identifier: X18-0425
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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®.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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: 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

  30 days

Secondary Outcomes (2)

• Central Sensitisation Inventory - short form (CSI-9)

  30 days

• Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance

  30 days

Study Arms (2)

Active Pulsed Shortwave therapy

ACTIVE COMPARATOR

Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.

Device: Pulsed Shortwave Therapy

Placebo Pulsed Shortwave therapy

PLACEBO COMPARATOR

Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.

Device: Placebo Pulsed Shortwave Therapy

Interventions

Pulsed Shortwave Therapy DEVICE

Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day

Also known as: ActiPatch

Active Pulsed Shortwave therapy

Placebo Pulsed Shortwave Therapy DEVICE

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

Also known as: Placebo ActiPatch

Placebo Pulsed Shortwave therapy

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioElectronics Corporation: lead
• Royal Prince Alfred Hospital, Sydney, Australia: collaborator

Study Officials

• Graeme Campbell

  Royal Prince Alfred Hospital, Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Arun Aggarwal, Professor

  Royal Prince Alfred Hospital, Sydney, Australia

  STUDY CHAIR

Central Study Contacts

Graeme Campbell

CONTACT

(02) 95159016; graeme.campbell1@health.nsw.gov.au

Arun Aggarwal, Prof

CONTACT

02 9515 9870; arun.a@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 5, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share