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Trial registered on ANZCTR


Registration number
ACTRN12613000328774
Ethics application status
Approved
Date submitted
20/03/2013
Date registered
25/03/2013
Date last updated
10/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulsed Electromagnetic Energy as an Adjunct to Normal Physiotherapy care for the Treatment of Acute Low Back Pain: A Randomised Controlled Trial.
Scientific title
Pulsed Electromagnetic Energy as an Adjunct to normal Physiotherapy Care for the Treatment of Acute Mechanical Low Back Pain: A Double Blind Randomised Placebo Controlled Trial using the Oswestry Disability Index.
Secondary ID [1] 282153 0
Nil
Universal Trial Number (UTN)
U1111-1140-8279
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 288659 0
Condition category
Condition code
Musculoskeletal 289003 289003 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 289031 289031 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulsed Electromagnetic Energy (PEME) Plus Normal Physiotherapy. PEME is a safe form of non-thermal non-ionizing electromagnetic radiation. PEME is thought to assist the body’s own processes, in particular reduction in pain and swelling, and speeding the healing process. PEME treatment procedure: The device is an Actipatch pulsed radiofrequency energy device that emits a safe form of non-thermal non-ionizing electromagnetic radiation. The device has a carrier frequency of 27.12MHz, a pulse rate of 1000 Hz and a 100-micro seconds burst width. The peak burst output power of the 12cm antenna is approximately 9.8mW capable of covering a surface area of approximately 103cm2. The circuitry consists of low voltage (3V) digital electronics that control all timing functions. It produces a therapeutic radiofrequency field, with the antenna placed directly over the therapeutic site. It will be kept in place with a comfortable elastic Velcro wrap worn around the waist. It is to be worn continuously for the first 7 days, after which use is discontinued.

Normal Physiotherapy consists of standard manual therapy and exercise based approaches used by physiotherapists to treat low back pain.
Treatment will be given for twice per week for 4 weeks and last for 30 mins on each occasion.
Adherence to the protocol will be monitored by the clinic receptionist and the treating physiotherapist via appointment calendars and verbal feedback to the clinician.
Intervention code [1] 286762 0
Treatment: Devices
Comparator / control treatment
Placebo Pulsed Electromagnetic Energy (PEME) Plus Normal Physiotherapy.
The placebo PEME device is exactly the same as the active device and is to be kept in place with a velcro strap for 24 hours a day for the first 7 days, as per the treatment group. The PEME device to be used gives off a safe form of electromagnetic energy that does not produce any sensation to you at all. The placebo device has been altered so that no energy is given off.

Normal Physiotherapy consists of standard manual therapy and exercise based approaches used by physiotherapists to treat low back pain.
Treatment will be given for twice per week for 4 weeks and last for 30 mins on each occasion.
Control group
Placebo

Outcomes
Primary outcome [1] 289119 0
Oswestry Disability Index Score
Timepoint [1] 289119 0
4 weeks after initial treatment.
Secondary outcome [1] 301854 0
Patient Specific Functional Scale (PSFS)
Timepoint [1] 301854 0
4 weeks after the initial consultation
Secondary outcome [2] 301855 0
Numerical Pain Rating Scale (NPRS)
Timepoint [2] 301855 0
4 weeks after the initial consultation

Eligibility
Key inclusion criteria
Participants with mechanical low back pain present for 6 weeks or less, with or without leg pain, aged 18 years or older.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cauda equina, presence of tumour, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, signs consistent with nerve root compression, spinal fracture, prior surgical history of the lumbar spine, current pregnancy, cardiac pacemaker, cardioverter defibrillator, neuro-stimulator or any active medical device or metallic implant within the area of the lower back. Failure to grant consent to the investigator to inform the GP of participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting at the School of Physiotherapy Clinics with mechanical low back pain will be given an advertisement for the study. If they are interested they will be given the information and consent forms, and a physiotherapist will answer any questions. A computer generated list will be used to randomise participants, and the clinics receptionist will offer a choice of one of forty opaque sealed envelopes to determine group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated list will be used to randomize participants meeting the inclusion criteria into one of two groups, PEME or Placebo. After the participants have given informed consent, the clinic administrator will be responsible for randomization and issuing a PEME device according to group allocation, then the treating physiotherapist will instruct the participant on its use. Both participant and clinician will be blinded to group allocation. The treating physiotherapist will provide standard treatment and only be aware that participants are to wear the PEME device over the painful area continuously for the first 7 days.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using the statistical package for the social sciences software (SPSS); with alpha set to 0.05. Normal descriptive statistics of the two groups such as means and standard deviations will be calculated. ANCOVA will be used to analyze the outcomes data at initial and follow-up time-points.From previous studies in the literature it was determined that 16 points on the Oswestry Disability Index was a minimal Clinical Important Difference. To detect a difference between groups of at least 16 points on a 100 point scale (Oswestry score), with alpha set to 0.05 and power of 80% we require 20 participants per group to allow for up to 20% drop out.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4946 0
New Zealand
State/province [1] 4946 0

Funding & Sponsors
Funding source category [1] 286923 0
Commercial sector/Industry
Name [1] 286923 0
Bioelectronics Corporation
Address [1] 286923 0
4539 Metropolitan Court,
Fredrick, MD 21704,
USA
Country [1] 286923 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street,
Dunedin 9010
Country
New Zealand
Secondary sponsor category [1] 285711 0
None
Name [1] 285711 0
Address [1] 285711 0
Country [1] 285711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288980 0
Health and Disability Ethics Committee
Ethics committee address [1] 288980 0
Ethics committee country [1] 288980 0
New Zealand
Date submitted for ethics approval [1] 288980 0
29/03/2013
Approval date [1] 288980 0
06/05/2013
Ethics approval number [1] 288980 0
13/NTA/40

Summary
Brief summary
The main purpose of the study is to explore the added benefit, if any, of using a new application of pulsed electromagnetic energy (PEME) as an adjunct to normal physiotherapy approaches used in New Zealand for the treatment of low back pain.
The experimental hypothesis is that the use of PEME as an adjunct to normal physiotherapy techniques will be effective in reducing pain and disability in patients suffering from low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38626 0
Dr Steve Tumilty
Address 38626 0
Centre for Health Activity and Rehabilitation Research
325 Great King Street
University of Otago
Dunedin 9010
Country 38626 0
New Zealand
Phone 38626 0
+64 3 479 7193
Fax 38626 0
+64 (03) 479 3979
Email 38626 0
steve.tumilty@otago.ac.nz
Contact person for public queries
Name 38627 0
Dr Steve Tumilty
Address 38627 0
Centre for Health Activity and Rehabilitation Research
325 Great King Street
University of Otago
Dunedin 9010
Country 38627 0
New Zealand
Phone 38627 0
+64 3 479 7193
Fax 38627 0
+64 (03) 479 3979
Email 38627 0
steve.tumilty@otago.ac.nz
Contact person for scientific queries
Name 38628 0
Dr Steve Tumilty
Address 38628 0
Centre for Health Activity and Rehabilitation Research
325 Great King Street
University of Otago
Dunedin 9010
Country 38628 0
New Zealand
Phone 38628 0
+64 3 479 7193
Fax 38628 0
+64 (03) 479 3979
Email 38628 0
steve.tumilty@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary