An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
The purpose of this study is to evaluate the efficacy and safety of tramadol
 hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to
 severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to
 the bones) outpatient or emergency setting.
This is an open-label (all people know the identity of the intervention), non-randomized,
 multi-center (when more than one hospital or medical school team work on a medical research
 study) and prospective (study following participants forward in time) study of tramadol
 hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol
 hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram
 [mg] and paracetamol 325mg). Participants may be given the additional dose according to the
 clinical requirement. The total treatment duration will be 6 hours. The total study duration
 will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief.
 Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours
 respectively after the first dose; and the drug efficacy and overall satisfaction level at
 the end of 6 hours after the first dose. Participants' safety will be monitored throughout
 the study.
Inclusion Criteria:

 -  Intermittent or persistent pain for less than 3 months, required analgesic therapy,
 orthopedic surgery and emergency call participants suffering with severe neck,
 shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and
 severe form of illness in its early stage) exacerbation pain

 -  Pain intensity to be assessed using Numerical Rating Scale (NRS), NRS score more than
 or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain)

 -  During normal pain and stable feeling, can study pain assessment methods and can fill
 in pain control diary

 -  Be willing to participate in the study and must give written informed consent

 Exclusion Criteria:

 -  Have used strong opium kind of medication 7 days prior to the enrolment

 -  Have severe mental disease or using antipsychotic (agent that control agitated
 psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and
 exert a quieting effect) medication for medical treatment

 -  Drug abuse/dependence, or chronic alcohol abuse/depend on history

 -  Pregnant or lactating women

 -  Unable to tolerate tramadol or any failed treatment in past by using tramadol

 -  Comparatively more severe pain in other parts of the body than that of the pain
 mentioned in the research