ActiPatch Therapy for Back Pain

Back Ache Clinical Trial

Official title:

A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02601807
• Other study ID #: 15/LO/0926
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2015
• Last updated: November 6, 2015
• Start date: August 2015

Study information

• Verified date: November 2015
• Source: University of Oxford
• Contact: Tipu Z Aziz
• Phone: 01865231885
• Email: tipu.aziz[@]nds.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The ActiPatch is a cutaneous device which is CE marked approved for relief of pain. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. However there is no class 1 evidence for this on back pain. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at two weeks, the efficacy or otherwise can be established. Low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

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.

• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

• Male or female ages 18-90 years old with stable chronic low back pain

• =3 months duration of chronic low back pain

• a current VAS pain rating =5/10

• no radiating pain below the knee

• =75% back or buttock pain rather than lower extremity pain

• Able to complete and tolerate treatment for the study period.

Exclusion Criteria:

• Female participant who is pregnant

• Significant renal or hepatic impairment.

• Prior home use of pulsed shortwave therapy

• Prior history of spinal fusion or failed spinal surgery syndrome.

• Laminectomy, laminotomy or discectomy within 12 months of enrollment.

• Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency neuroablation within 6 months of enrollment.

• Any addition of strong opiates, pregabalin and gabapentin to the treatment regime during the course of the trial

• Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.

• Patients using personal home based electrical stimulation devices

• Patients with other concomitant illnesses (e.g., malignancy, osteoporosis) which, in the opinion of the investigator, would preclude successful patient participation will also be excluded

• Active psychiatric disorders (as evidenced by use of antipsychotic or medication).

• Patients diagnosed with history of significant mood disorder will be excluded (depression or anxiety with adequate control would be acceptable).

• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.

• Participant with life expectancy of less than 6 months, or inappropriate for placebo medication.

• 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 not able to understand verbal or written English, and for whom adequate translation/interpretation cannot be readily obtained.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Ache

Intervention

Device:
• ActiPatch (active)
Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.
• ActiPatch (placebo)
Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-related disability, indexed by the Oswestry Disability Index (ODI)		Change from baseline ODI score at 2 weeks	No
Secondary	Subjective pain, indexed by Visual analogue pain scale		Change from baseline visual analogue score over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary	No
Secondary	Medication intake		Change from baseline medication intake rate over the course of 2 weeks, recorded daily during the 2 week period by participant as part of a pain diary	No
Secondary	Pain related disability, indexed by the Roland Morris Instrument		Change from baseline Roland Morris Instrument scores at 2 weeks	No
Secondary	Quality of life, indexed by the EQ-5D-5L questionnaire		Change from baseline EQ-5D-5L scores at 2 weeks	No