CompletedPhase 4ACTRN12613000328774

Pulsed Electromagnetic Energy as an Adjunct to Normal Physiotherapy care for the Treatment of Acute Low Back Pain: A Randomised Controlled Trial.

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.

Sponsor

University of Otago

Enrollment

40 participants

Start Date

May 13, 2013

Study Type

Interventional

Conditions

Low Back Pain

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

Participants with mechanical low back pain present for 6 weeks or less, with or without leg pain, aged 18 years or older.

Exclusion Criteria1

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.

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Interventions

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.