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

NCT ID: NCT03828864

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-05-01

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®.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Pulsed Shortwave therapy

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

Group Type: ACTIVE_COMPARATOR

Pulsed Shortwave Therapy

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Pulsed Shortwave Therapy

Intervention Type: DEVICE

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

Interventions

Pulsed Shortwave Therapy

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

Intervention Type: DEVICE

Placebo Pulsed Shortwave Therapy

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

Intervention Type: DEVICE

Other Intervention Names

ActiPatch; Placebo ActiPatch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role: collaborator

BioElectronics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graeme Campbell

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital, Sydney, Australia

Arun Aggarwal, Professor

Role: STUDY_CHAIR

Royal Prince Alfred Hospital, Sydney, Australia

Central Contacts

Graeme Campbell

Role: CONTACT

graeme.campbell1@health.nsw.gov.au

(02) 95159016

Arun Aggarwal, Prof

Role: CONTACT

arun.a@sydney.edu.au

02 9515 9870

Other Identifiers

X18-0425

Identifier Type: -

Identifier Source: org_study_id