Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 May;58(3):637-643.
doi: 10.3349/ymj.2017.58.3.637.

Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials

Jae Ho Yang  1 , Kyung Soo Suk  1 , Byung Ho Lee  2 , Woo Chul Jung  1 , Young Mi Kang  1 , Ji Hye Kim  1 , Hak Sun Kim  1 , Hwan Mo Lee  1 , Seong Hwan Moon  3
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials

Jae Ho Yang et al. Yonsei Med J. 2017 May.

Abstract

Purpose: Nonsteroidal anti-inflammatory drugs are a mainstay for medical treatment of chronic lower back pain (CLBP). Increased dose intervals for medication have been associated with increased patient adherence to prescriptions. The purpose of this clinical trial was to compare the efficacy and safety of a once daily dose of aceclofenac controlled release (CR) and a twice daily dose of aceclofenac for CLBP management.

Materials and methods: A prospective, randomized, single center, open-label clinical trial was performed to compare the efficacy and safety of aceclofenac CR (200 mg once daily) to aceclofenac dose (100 mg twice daily). Fifty patients in each group were enrolled for the study. The primary end point was Visual Analogue Scale (VAS) change at baseline to that at 2 weeks after medication and safety profiles. Also, change in quality of life measured by EuroQoL 5D (EQ-5D) and Oswestry Disability Index (ODI) functional score for the lumbar spine were also assessed.

Results: Within groups at pre- and post-treatment, there were significant VAS reductions for aceclofenac CR and aceclofenac (p=0.028). EQ-5D increased significantly in both groups (p=0.037). ODI scores decreased significantly in both groups (p=0.012). However, there were no significant differences between aceclofenac CR and aceclofenac at pre- and post-treatment. Patients with aceclofenac CR showed significant increases in heartburn and indigestion and adverse gastrointestinal effects, compared to aceclofenac.

Conclusion: In patients with CLBP, aceclofenac CR and aceclofenac demonstrated significant symptomatic pain relief, improvement in quality of life and functional scores. Aceclofenac CR slightly increased gastrointestinal adverse effects, such as heartburn and indigestion.

Keywords: Chronic lower back pain; NSAIDs; aceclofenac.

PubMed Disclaimer

Conflict of interest statement

The authors have no financial conflicts of interest.

Figures

Fig. 1
Fig. 1. Screening, randomization, and follow-up of clinical trial. CR, controlled release.
Fig. 2
Fig. 2. (A) Change in Visual Analogue Scale (VAS) presented as mean±standard deviation. (B) Change in calculated EuroQoL 5D (EQ-5D) presented as median and interquartile range (IQR). (C) Change in Oswestry Disability Index (ODI), presented as median and IQR. Comparison between aceclofenac controlled release (CR; 200 mg once daily) and conventional aceclofenac (100 mg twice daily) showed there was significant reduction of pain and ODI score, and increase in EQ-5D for each group at 2 weeks, however, there was no difference between groups pre- and post-treatment for VAS, ODI, and EQ-5D. *p<0.05, †Non-significant.
Fig. 3
Fig. 3. Change in each dimension (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) for EuroQoL 5D pre- to post-treatment with aceclofenac CR (200 mg once daily) and conventional aceclofenac (100 mg twice daily) over the 2 week trial. With the exception of self-care in the aceclofenac group, all dimensions showed improvement post-treatment. CR, controlled release.
See this image and copyright information in PMC

References

    1. Witt CM, Pach D, Reinhold T, Wruck K, Brinkhaus B, Mank S, et al. Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain. Eur J Pain. 2011;15:193–197. - PubMed
    1. Andrade NS, Flynn JP, Bartanusz V. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge. Spine J. 2013;13:1698–1704. - PubMed
    1. Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids compared with placebo or other treatments for chronic low back pain: an update of the Cochrane Review. Spine (Phila Pa 1976) 2014;39:556–563. - PubMed
    1. Cawston H, Davie A, Paget MA, Skljarevski V, Happich M. Efficacy of duloxetine versus alternative oral therapies: an indirect comparison of randomised clinical trials in chronic low back pain. Eur Spine J. 2013;22:1996–2009. - PMC - PubMed
    1. Schattenkirchner M, Milachowski KA. A double-blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of aceclofenac with diclofenac resinate in patients with acute low back pain. Clin Rheumatol. 2003;22:127–135. - PubMed

Publication types