Tuesday, 3 April 2012

Conculsion

To date, there has been little empirical research regarding the efficacy of the analgesic effects elicited by the application of TSE (Palmer et al., 2009). Although the current evidence shows both positive and anecdotal results on the affects of TSE in reducing chronic pain, TSE could still be used in clinical practice. TSE could possibly be added to the treatment toolbox of physiotherapists and clinicians in the fight against chronic pain, even if TSE works as a placebo. Therefore, even though further research should be conducted on TSE and its pain relieving affects, clinically it still should be used as a treatment tool if other treatments fail.


References


Palmer, S., Cramp, F., Propert, K., & Godfrey, H. (2009). Transcutaneous electrical nerve   stimulation and Transcutaneous spinal electroanalgesia: A preliminary efficacy and mechanisms-based investigation. Physiotherapy. 95: pp. 185-191. 


Friday, 30 March 2012

Indications, Contraindications and Safety of TSE

Indications

Acticare asserts that TSE is most beneficial for chronic conditions, especially for post-operative pain and patients experiencing neurogenic pain. Acticare conducted a survey to investigate the extent of pain relief in 150 patients using the TSE device, with an average age of 65 years and an average pain duration of 9.5 years. The survey results showed that 79% of the patients experienced 50% or greater pain relief after using the device (Acticare, 2006). Based on these results and other investigations, the following indications are presented in the Acticare TSE user manual (http://www.acticare.com/docs/Acticare_TSE_manual.pdf).
  • Back pain
  • Arthritis
  • Persistent neck pains
  • Headaches
  • Migraine
  • Old injuries
  • Cervical and lumbar spondylosis
  • Insomnia
  • Period pains
  • Chronic pancreatitis
  • Fibromyalgia
  • Burnt out rheumatoid arthritis
  • Osteoporosis Pain due to muscle spasm
  • Post mastectomy pain
  • Sciatica
  • Post Shingles pain
  • Stress
  • Neuralgia
Contraindications & Precautions

The contraindications and precautions for using TSE are very similar to other electrotherapy devices, which are most commonly patients with pacemakers, metallic implants, epilepsy and patients which are pregnant (Acticare User Manual 2006). Acticare states the following contraindications and precautions for use of TSE.

Contraindications
Precautions
  • Cardiac pacemakers
  • Pregnancy
  • Epilepsy
  • Drowsiness
  • Transthoracic stimulation
  • Tumours
  • Cranial stimulation
  • Patients with Neurological damage
  • Skin and vascular problems
  • Patients with spinal cord stimulators
  • Pain associated with an unknown cause
  • In conjunction with high frequency surgical equipment
  • Carotid sinus stimulation
  • Operation close to radio frequency sources

  •  
  • Operation in water

Safety

The Acticare TSE device is built in accordance with international electrotechnical commission (IEC) medical devices standard 60601-2-10: Particular requirements for the safety of nerve and muscle stimulators. Acticare pledges that the device is intrinsically safe and thus cannot generate an unsafe sustained current or pulse charges. Acticare also states that it has been used by 14000 patients with no reported serious side effects or adverse reactions with medications. However its user manual does warn the potential of adverse reactions such as skin irritation, electrolysis and adverse effects which may include the following:
  • Nausea
  • General malaise
  • Vomiting
  • Fainting
  • Headaches/migraines
  • Epileptic seizure
  • Tinnitus
  • Numbness
  • Loss of muscle tone
  • Swelling and redness
 References

1) Acticare: TSE notes for practitioners (2006). Retrieved from http://www.acticare.com/docs/SM-00040_TSE_Notes_Practitioner.pdf 

1) Acticare: User Manual (2006). Retrieved from http://www.acticare.com/docs/Acticare_TSE_manual.pdf




Thursday, 29 March 2012

TSE v. TENs & Other Electrophysiological Devices


Currently there has been very little research conducted which compares Transcutaneous Spinal Electroanalgesia (TSE) to other electrophysiological devices. However, Acticare has made some comparisons between their TSE and TENS devices and the table below portrays the differences between the devices.


 Table comparing Acticare TSE to TENS. Table obtained from Acticare (Referenced Below)

Although Acticare has claimed to have produced a product with positive results, some clinical trials conducted independently have produced different results. A recent clinical trial compared the effects of TSE and TENS in reducing chronic pain caused by Brest cancer (Robb et.al, 2007). The results showed that both TSE and TENS were both effective in reducing pain, however these changes may be have been caused by a placebo response.  Therefore, suggesting that TSE could be used clinically as a tool to treat chronic pain instead of TENS.

Another randomized controlled trial compared the affects of TENs, TSE and a placebo on altering the mechanical pain thresholds of thirty-four healthy adults (Palmer et.al, 2009). The results show that neither the control nor the intervention groups did not affect the mechanical pain threshold of the individuals. Therefore, the subjects in this study did not achieve a higher pain threshold.

Currently there is little literature which compares the effects of TSE to TENs or any other electrophysiological agent. Hence, to gain a greater understanding of Acticare TSE and how it can fit clinically into physiotherapy treatment, more research must be conduced on TSE. However, the current research suggests that TSE is no more beneficial then TENs or other electrophysiological agents.

References 

A table comparing Acticare TSE and TENs. Retrieved March 29, 2012, from http://www.acticare.com.au/home/about/TSEvsTENS.asp

Palmer, S., Cramp. F, Propert, K. & Godfrey, H. (2009). Transcutaneous electrical nerve stimulation and transcutaneous spinal electroanalgesia: A preliminary efficacy and mechanisms-based investigation. Physiotherapy, 95 (3), 128-191.

Robb, K. A., Newham, D. J. & Willians, J. W. (2007). Transcutaneous Electrical Nerve Stimulation vs. Transcutaneous Spinal Electroanalgesia for Chronic Pain Associated with Breast Cancer Treatments. Journal of Pain and Symptom Management, 33 (4), 410- 419.


Wednesday, 28 March 2012

How TSE Works and its Effectiveness


How TSE Works and its Effectiveness 

It has been common practice to stimulate the spinal cord (dorsal column) through the neurosurgical implantation of electrodes. Although there have been no reported side-effects from this electrical device, infection associated with the surgical implantation of wires and the stimulator is a long-term risk factor that needs to be addressed. Dr Alexander Macdonald and Dr Tim Coates sought to find a non-invasive method of spinal cord stimulation via surface electrodes. To elicit a voltage gradient within the spinal cord, the electrodes need to provide a current of sufficient amplitude to penetrate the tissues that lie between the skin and spinal cord. Existing electrotherapeutic devices such as Transcutaneous Electrical Nerve Stimulation (TENS) apply relatively broad pulse durations (50-200 µsec) that aim to excite peripheral nerves at low amplitude. Macdonald and Coates (1995) examined the effects of brief duration pulses (≤10 µsec) to produce a painless current of sufficient amplitude to stimulate the spinal cord.



Sourced from Acticare Website





 In order to produce an action potential in peripheral nerves via electrical stimulation, the input current must have a low to moderate voltage input and a high pulse width (Sato & Perl, 1991). TSE works by reducing the pulse width from 20- 200 to 4 µsec and increasing the Voltage output, therefore increasing patients pain tolerance and producing little sensation (i.e tingling) (Macdonald and Coates, 1995). This produces widespread analgesia when electrodes are placed over the spinal cord. Thus, TSE works by stimulating the spinal cord with high voltage, low amplitude current directly to the spinal nerve root. 

Electrical pulses employed by TSE can be delivered at regular intervals in the range of 100 to 50kHz, however most clinical studies have used a 2-20kHz range (Acticare, 2012). TSE pulses are typically composed of a biphasic square wave of short duration (≤4ms). This pulse duration is suggested to be too brief to elicit action potentials in peripheral nerves at voltages below 150V (peak-to-peak). Furthermore, like TENS and interferential the short pulse durations of TSE penetrates deeper into the body resulting in a reduction of skin impedance.

Initially TSE was strictly set at a frequency of 100Hz, however studies shave shown that the extent of TSE’s analgesic effect is dependent on its frequency (Acticare, 2012). It has been found in clinical trails that higher TSE frequencies increased the time to analgesic onset and its overall affect. For example, at 100 Hz, 40 minutes of application may be needed to produce analgesia, requiring only 8 minutes at a frequency of 150 kHz (Li & Bak, 1976).




A study was conducted by the inventors of TSE sought to determine the effectiveness of TSE on chronic pain conditions. 100 patients with a variety of chronic pain causing conditions received TSE to the appropriate spinal nerve root at a frequency of 600Hz and a pulse width of 4 µsec (square wave), 30min/day for 2 weeks. The patient’s pain levels were assessed via a Visual Analogue Scale (VAS). Results showed that the TSE treatment reduced pain by 60% in patients whose pain was of relatively recent origins (2.6 years) (Macdonald and Coates, 1995). Although, this study’s results showed positive outcomes for its subjects, more clinical research should be conducted on TSE by independent researches to decrease bias towards TSE and to compare it to a placebo or other electrophysiological devices.

In another double blind, randomized control trial comparing the effects of TSE to a placebo found different results. Eight subjects with chronic critical limb ischemia received a placebo treatment for one week, followed by the actual TSE treatment at a frequency of 2500 Hz and a voltage of 150V to the spinal cord. McGill Pain Questionnaire measured patient’s pain perception. The results showed that daily use of TSE did not decrease the subject’s pain or improve their physical function (Simpson & Ward, 2004). Therefore, suggesting that TSE did not affect the quality of life for chronic pain patients.


Another double blind randomized controlled clinical trial which supports the research conducted by Simpson & Ward, compared TSE to a placebo in chronic low back pain patients. 58 patients with low back pain were randomly assigned to a placebo and a TSE receive group and patients were assessed for pain via the Visual Analogue Scale (VAS). Subjects received the TSE or placebo treatment twenty minutes per day for 2 weeks. The results showed no difference in mean pain scores between the TSE and placebo groups (Thompson et.al, 2008). Therefore, the more recent research conducted by Simpson & Ward and Thompson et.al suggests that TSE is not effective in treating chronic pain conditions.

Currently, the evidence on TSE is limited and the benefits and contraindication of TSE are still unknown. To gain a stronger understanding of TSE and the benefits it may have in clinical practice, further research must be conducted.



                                                                               




 References



Macdonald, A.J.R. & Coates, T.W. (1995). The Discovery of Transcutaneous Spinal Electroanalgesia and its Relief of Chronic Pain. Physiotherapy. 81 (11): pp. 653-61.


Sato, J. & Perl, E.R. (1991). Adrenergic excitation of cutaneous pain receptors induced by peripheral nerve injury. Science. 251 (5001): pp. 1608-10.


Simpson, K. H. & Ward, J. (2008). A Randomised, Double- Blind, Crossover Study of the use of Transcutaneous Spinal Electroanalgesia in Patients with Pain from Chronic Critical Limb Ischemia. Journal of Pain Symptom Management, 28 (5), 511- 519.


Thompson, J. W., Bower, S. & Tyrer, S. P. (2008). A double blind randomized controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain. European Journal of Pain, 12 (3), 371- 377.






Saturday, 25 February 2012

What is TSE?





Acticare Transcutaneous Spinal Electroanalgesia (TSE) is a clinically proven form of electrical stimulation for treating chronic pain through eliciting analgesia. TSE is a relatively new electrical pain relief modality which uses a very brief pulse duration, usually four microseconds or less using electrodes placed over the skin underlying the spinal cord 1. The brief pulse duration permits high voltages to be reached before any sensation is felt, allowing penetration of deeper tissues and influence the central nervous system 1.


Figure 1: TSE pulse width and pulse voltage compared to TENS.
Figure 2: Acticare TSE Device


TSE was first discovered in 1991 by Drs Alex Macdonald and Tim Coates as an alternative to Spinal Cord Stimulation (SCS) which is an invasive neurosurgical implementation of electrodes 2. SCS was effective for chronic pain however had drawbacks due to its invasiveness, costs and risk of infection. In 1995 Dr Macdonald and Coates published their research report on TSE and found that it significantly reduced tenderness in patients with chronic unilateral tenderness compared to the contralateral side (p < 0.001) 2. They also established that TSE is significantly better at producing an analgesic effect when compared to TENS. The exact mechanism of TSE is not known yet but is theortisized that it effects the rate of release of certain central ligands and their effect on ligand gated receptors, as well as causing changes in voltage gated ion channels 1. Macdonald and Coates concluded the following pros of TSE:
  • Non-invasive
  • High Compliance
  • Standardised electrode location
  • Minimum onset time of analgesic effect is 8 minutes
  • Minimum 8 hours of pain relief after first treatment
  • Increasing Cumulative pain relief effect after successive treatments


Figures 3 and 4 show the two primary electrode placements used with TSE for most effective outcomes to occur. These placements are optimal as Macdonald and Coates state the closer the electrodes are placed together then the lower voltage needed to produce tingling sensations which inturn prevents electrical current reaching the spinal cord 2. TSE allows electrode location to be standardised to the spinal cord regardless of the location of pain due to the fact that TSE provides stimulation to the CNS. Therefore the electrodes will always be placed over the spinal cord regardless of whether pain is occurring at the spine, hip, knee or shoulder 2.

Figure 3: Electrodes placed on skin underlying transverse processes of C3/C4.
Figure 4: Electrodes placed on skin underlying spinous processes of T1 and T12.





References:


1) Acticare: TSE notes for practitioners (2006). Retrieved from http://www.acticare.com/docs/SM-00040_TSE_Notes_Practitioner.pdf


2) Macdonald, A.J. Coates, T.W. (1995). The discovery of TSE and its relief of chronic pain. Journal of Physiotherapy 81(11).








* note: none of the authors of this blog have any commercial interests in Acticare TSE.