Back AcheNCT02601807
ActiPatch Therapy for Back Pain
A study testing ActiPatch (active) in people with Back Ache, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Back Ache
- What is being tested?
- ActiPatch (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Tipu Z Aziz, 01865231885, tipu.aziz@nds.ox.ac.uk
Tipu Z Aziz
About this study
Official title: A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain
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.
- Conditions
- Back Ache
- Being tested
- ActiPatch (active), ActiPatch (placebo)
- Keywords
- Back, Pain, PSWT, ActiPatch, Pulsed shortwave therapy
- Medical subject headings
- Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiPatch (active)Device
Also called Pulsed shortwave therapy (placebo)
Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.
ActiPatch (placebo)Device
Also called Pulsed shortwave therapy (active)
Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Subjects given active ActiPatch device before or after crossover (randomised) Receives: Device: ActiPatch (active) |
| Placebo | Placebo comparator | Subjects given placebo ActiPatch device before or after crossover (randomised) Receives: Device: ActiPatch (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-related disability, indexed by the Oswestry Disability Index (ODI)
Measured: Change from baseline ODI score at 2 weeks
Secondary outcomes (4)
Subjective pain, indexed by Visual analogue pain scale
Measured: 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
Medication intake
Measured: 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
Pain related disability, indexed by the Roland Morris Instrument
Measured: Change from baseline Roland Morris Instrument scores at 2 weeks
Quality of life, indexed by the EQ-5D-5L questionnaire
Measured: Change from baseline EQ-5D-5L scores at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back AcheStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601807
- Sponsor's protocol ID
- 15/LO/0926
- Status last verified
- May 2016
- First submitted
- 21 Oct 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Assess the Benefits of ActiPatch-Pulsed Shortwave Therapy for Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT02601807
- Acronym / sponsor ID
- 15/LO/0926
- Conditions
- Back Ache
- Keywords
- Back, Pain, PSWT, ActiPatch, Pulsed shortwave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: ActiPatch (active)Subjects given active ActiPatch device before or after crossover (randomised) |
| Placebo | Placebo comparator | Device: ActiPatch (placebo)Subjects given placebo ActiPatch device before or after crossover (randomised) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiPatch (active)Also: Pulsed shortwave therapy (placebo)Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy. | Device | Active |
| ActiPatch (placebo)Also: Pulsed shortwave therapy (active)Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device. | Device | Placebo |
Primary outcome
Pain-related disability, indexed by the Oswestry Disability Index (ODI)
Time frame: Change from baseline ODI score at 2 weeks
4 secondary outcomes
Subjective pain, indexed by Visual analogue pain scale
Time frame: 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
Medication intake
Time frame: 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
Pain related disability, indexed by the Roland Morris Instrument
Time frame: Change from baseline Roland Morris Instrument scores at 2 weeks
Quality of life, indexed by the EQ-5D-5L questionnaire
Time frame: Change from baseline EQ-5D-5L scores at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiPatch (active) in people with Back Ache, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tipu Z Aziz (01865231885, tipu.aziz@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related disability, indexed by the Oswestry Disability Index (ODI) (time frame: Change from baseline ODI score at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.