Aceclofenac controlled release (CR) and Aceclofenac demonstrated significant symptomatic pain relief, improvement in quality of life and functional scores in patients with Chronic low back pain (CLBP).

Chronic lower back pain (CLBP) is the most prevalent disorder associated with morbidity and high healthcare costs in all age groups worldwide. The treatment regimens for CLBP are multi-modal, including medication, injection, physical therapy, exercise, back school, and sometimes surgery. The widely accepted treatment for CLBP is the use of single or cocktail medical therapies with or without narcotics. Among medical treatments, non-steroidal anti-inflammatory drugs (NSAIDs) are more often prescribed than muscle relaxants, antidepressants, anti-epileptics, or narcotics. Aceclofenac is an NSAID phenylacetic acid derivative, {2-[(2, 6-dichlorophenyl) amino]-phenylacetoxyacetic acid} widely and safely prescribed for musculoskeletal pain associated with rheumatic, degenerative, and traumatic injury etiologies. Aceclofenac also appears to be useful in managing acute and chronic LBP. It exhibits a broad safety profile. NSAIDs are associated with adverse side effects like gastrointestinal effects, cardiovascular risks, and patient's adherence, but Aceclofenac and Diclofenac (acetic acid NSAIDs) are not associated with adverse cardiovascular events. In case of patient's adherence, dose interval becomes a crucial factor. Increased dose intervals for medication are linked with improved patient adherence to prescription.

Rationale behind the research:

• The increased dose interval was found to be linked with increased patient adherence to NSAID and osteoporotic medication. The present investigation studied the patients' adherence to Aceclofenac controlled release and increased dose interval.

Objective:

To compare the effectiveness and safety of a once-daily dose of Aceclofenac controlled release (CR) and a twice-daily dose of Aceclofenac for CLBP management.

Study outcome measures

Primary outcomes: Visual analogue scale (VAS) change at baseline to that at 2 weeks after medication and safety profiles.

Other outcomes: Change in quality of life measured by EuroQoL 5D (EQ-5D) and Oswestry Disability Index (ODI) functional score for the lumbar spine.

Time Points:  At baseline and after 2 weeks

Study outcomes:

Baseline: There were no statistically significant differences observed at baseline

• Primary outcomes:

VAS (0–100 mm) pain intensity was significantly reduced in both groups: aceclofenac CR, (before 58.2±14.0, after 35.7±17.1, p<0.05); aceclofenac, (before 64.0±13.1, after 45.5±20.8, p<0.05) {Fig 1}

There was no notable difference in pain intensity between groups pre and post-treatment

• Other outcomes:

Quality of life as measured by calculated EQ-5D increased significantly (p=0.037), and ODI spinal functional score decreased significantly (p=0.012) in both Aceclofenac CR and Aceclofenac groups

There was no notable difference between groups for other ODI items pre- and post-treatment

Patients with Aceclofenac CR showed significant increases in heartburn and indigestion and adverse gastrointestinal effects, compared to Aceclofenac

This study determined that both aceclofenac CR and aceclofenac were associated with significant pain reduction, improved quality of life, improved spinal function, and tolerable minor adverse effects. For all measures, only EQ-5D VAS showed no significant change pre- to post-treatment. For determining adverse effects of treatment, a questionnaire was explicitly filled for gastrointestinal symptoms. There were no serious gastrointestinal effects seen in either group during the study interval. The duration considered for CLBP was statistically insignificant, and chronicity of LBP seemed to have little effect on aceclofenac intervention, as shown in the results of uniform improvement in pain scale and quality of life measurements.

Overall, it was concluded that both dose regimens, aceclofenac CR, and aceclofenac, resulted in effective symptomatic pain relief, improvement in the quality of life and functional scores, and tolerable adverse gastrointestinal effects in subjects with CLBP in this prospective, randomized, single center, open-label.