“ Low back pain response after application of interferential therapy alone and in combination with aceclofenac + paracetamol , tramadol + paracetamol : A prospective , comparative , clinical study

Address for the Correspondence: Dr. Surendra Kumar Vidyarthi, Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Siruvachur 621 113, Perambalur, Tamil Nadu, India. E-mail: skvmanju9208@ yahoo.co.in “Low back pain response after application of interferential therapy alone and in combination with aceclofenac+paracetamol, tramadol+paracetamol: A prospective, comparative, clinical study”


MATERIALS AND METHODS
After approval of the present study from the Institutional Clinical Ethics Committee, total 80 assigned patients (30 male and 50 female) segregated in fi ve groups by using lottery method and prescribed the study therapy [Table 1].The study was prospective, clinical study.The duration of the study was 7 days dated from 2 nd July 2013 to 9 th July 2013 with 7 days follow-up.Study Centre was: Out-patient Orthopedics and Physiotherapy and Pharmacology Department, DSMCH (Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur, Tamilnadu, India.Sample Selection Criteria: Inclusion Criteria: The patients, who complained acute or chronic low-back pain, No history of taking analgesics in the previous one month and male and female of ages between 30 to 60 years with LBP, were included in the study.Exclusion Criteria: If any patient does not come under inclusion criteria, post-operative patients, patients who suffered from peptic ulcers, congestive heart failure, liver and renal impairment, multiple injuries with bony fractured patients, pain due to any cause; except related to acute or chronic low-back pain, unwilling to participate in the study patients; excluded from the study.If patients absconded from the study excluded too but, that shown as dropout in percent (%) during calculation.

Statistical calculation
After obtaining the data, we calculated the values, like percent, Mean, Standard Error, Standard Deviation, Dropout Rate from the study (in percent) and P-value by applying various statistical formulas, like' paired t-test', Kruskalwallis test (ANOVA) through online/offl ine free software, i.e., www.openepi.com.
The probability of pain reduction among Grp A (versus)Vs.D, Grp A Vs. E, Grp B Vs. D, Grp B Vs. E, Grp C Vs. D, Grp C Vs. E had 0.000175027, 0.00112602, 0.00117219, 0.00246735, 0.000432019, 0.00111177 respectively.Thus, it was indicating that the probability of the pain reduction was highly signifi cant in Group D Vs. Group C (P = 0.00043), and Group D Vs. Group A (P = 0.00017) [Table 6].

DISCUSSION
Schug SA. 2006 reported in his study that, combination of analgesics acting by various mechanisms offer increased effi cacy due to synergism/additive analgesic effects.So, the appropriate combinations when given increased analgesic effi cacy and decreased adverse effects could be expected in comparison with either treatment alone. [6]Aceclofenac is a proven effective NSAID, which is cox-2 selective, good GI tolerability and safer for cardiovascular system compared to other selective cox-2 inhibitors. [7]Paracetamol has been considered as highly effective, i.e., fi rst line drug for acute low back pain in all reviewed guidelines.Paracetamol is a good analgesic, antipyretic drug with weak anti-infl ammatory effect. [8]ramadol is a centrally acting opioid analgesic produces analgesic effect that begins within one hour of its administration and reaches a peak in 2 to 3 hours.Though, the oral opioids are effective in acute low back pain like sciatica, but it is not advisable for long term use.Thus, opioid should be considered a second-or third-line analgesic drug for a short period. [9]Every living cell has a membrane potential (of about -70 mV), if the membrane potential changes, it infl uences the movement of ions.The energy in the membrane (and other organelles of course) offers the potential to change the behaviour of the cell -one of the fundamental tenets of electrotherapy -and therefore make a difference to the behaviour of cells and tissues.[12] So, in the present study, the pain reduction response was highly signifi cant for Aceclofenac 100 mg + Paracetamol 500 mg + IFT treated Grp D (P = 0.0002027) and Tramadol 37.5 mg + Paracetamol 325 mg + IFT treated Grp E (P = 0.002136) than compared to Group A, B, C treated medication, but among Group D and E, the pain reduction was more in Group D than the Group E.

LIMITATIONS
This present study data has helped only viewing analgesic effectiveness of the Aceclofenac100 mg + Paracetamol 500 mg, Tramadol 37.5 mg + Paracetamol 325 mg, Interferential therapy alone and combination with this study drugs.

CONCLUSION
According to the fi nding and within the limitation of the present study, the combination of IFT (25-100 Hz) application 15 min at Lumbar region daily for 7 days + Tablet (Aceclofenac 100 mg + Paracetamol 500 mg) 1BD daily for 7 days is good combination as an analgesics, than, the Tablet (Aceclofenac 100 mg + Paracetamol 500 mg) alone.The combination of IFT application + Tablet (Tramadol 37.5 mg + Paracetamol 325 mg) 1 BD daily for 7 days is good combination analgesics, than, the Tablet (Tramadol 37.5 mg + Paracetamol 325 mg) alone.But, the IFT + (Aceclofenac 100 mg + Paracetamol 500 mg) therapy relieved pain much better, than IFT + (Tramadol 37.5 mg + Paracetamol 325 mg).So, Tramadol 37.5 mg + Paracetamol 325 mg + IFT (25-100 Hz) should be given 2 nd or 3 rd preference (van Tulder MW, 2006 also reported that tramadol should be 2 nd or 3 rd line drug) [9] than the (Aceclofenac 100 mg + Paracetamol 500 mg) + IFT.The Group A, B, C measures can also be used for the relief the pain, but the analgesic response was lesser than the group D, E measures application.
International Journal of Medicine and Public Health | Jul-Sep 2014 | Vol 4 | Issue 3

Table Source of variation Sum of squares d.f Mean square F statistics P-value [1]
P-value (two-tailed).

Table 3 : No. of patients who reported the Pain reduction in percent after the treatment
International Journal of Medicine and Public Health | Jul-Sep 2014 | Vol 4 | Issue 3