Health Condition 1: null- Patients with low back pain for at least 3 months Health Condition 2: M709- Unspecified soft tissue disorder related to use, overuse and pressure
Conditions
Interventions
Intervention1: Boswellia Serrata Extract Ointment applied to low back as External Application TID for 14 days. Subjects will be asked to take the ointment in the palm and spread over the
entire affect
Sponsors
Clinfound Clinical Research Services PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with low back pain for at least 3 months and assessed on the Quebec Task Force system on Spinal Disorders as either •Class 1 (pain without radiation to an extremity and without neurological signs) or •Class 2 (pain with radiation to an extremity, but not below the knee and without neurological signs) 3.Patients with a pain score > 4 on visual analog scale (VAS) in the low back region at the time of randomization 4.Patients ready to give written informed consent and willing to comply the study protocol
Exclusion criteria
Exclusion criteria: 1.Low back pain of Class 3 (pain with radiation distally beyond the knee and without neurologic signs) or Class 4 (Pain with radiation to the extremity and with neurologic signs) classified by the Quebec Task Force Classification for Spinal Disorders 2.Patients with specific causes of back pain (i.e. disc prolapse, spondylolisthesis, ischialgia, spinal stenosis), instability of the spine, spinal fractures, tumors, infections and inflammatory disorders, cervical spine syndrome or osteoporosis ,rheumatoid arthritis, Lymeâ??s arthritis, rheumatic factors >40 IU/L, seronegative spondyloarthropathies including ankylosing spondylitis, or neurologic etiology (i.e., radiculopathy, neuropathy, myelopathy) 3.Surgery for low back pain in the last 6 months or planning for surgical intervention during the course of the study. 4.Use of acetaminophen in last 12 hours; or any other systemic or topical analgesics, muscle relaxants in the last 7 days; and corticosteroids or nerve blocks in the past 4 weeks of randomization 5.Known hypersensitivity or intolerance or allergic type reactions to Boswellia or acetaminophen 6.History of known alcohol, analgesic or narcotic abuse within 2 years. 7.Sensitive skin and loss of skin at the application site. 8.Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential. 9.Presence of any severe medical or psychological condition or chronic condition /inflammation / infection that in the opinion of the investigator would compromise the patientâ??s safety or successful participation in the study. 10.Participation in any other clinical study within 30 days of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS score of pain experienced at end of study as compared to baseline.Timepoint: Baseline, Day 7, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Arthus Pain score (sum of current pain, average pain in last week and worst pain in last week) at the end of studyTimepoint: Baseline, Day 7, Day 14;Change in Modified Oswestry low back pain disability index score at end of study as compared to baselineTimepoint: Baseline, Day 7, Day 14;Pain relief score at the end of studyTimepoint: Baseline, Day 7, Day 14;Patients and investigators overall assessmentTimepoint: Baseline, Day 7, Day 14 | — |
Countries
India
Contacts
Public ContactSreejith Sreekumar
Arjuna Natural Extracts Limited
Outcome results
None listed