Comparison of the Efficiency and Safety of Oral Phenyramidol and Phenyramidol+Diclofenac Treatment in Muscle Spasms with Spinal Pain – Open-Label Study

Authors

Abstract

Muscle relaxants (MR) and nonsteroidal anti-inflammatory drugs (NSAID) are frequently used in the treatment of spasms and are effective combined or alone in muscle spasms. In this study, 30 patients aged 32-82 years, male and female, with moderate to severe acute spinal pain-muscle spasms due to trauma, sprain, or injury history were evaluated. Group 1 received phenyramidol 400 mg orally 3 times a day for 7 days. In the second group, phenyramidol (400 mg) three times a day + diclofenac (75 mg) once a day was given orally for 7 days. Patients were evaluated on the 0th and 7th days in terms of muscle spasm level, pain intensity, and side effects. Side effects were noted for clinical safety. Evaluation was performed at the start of treatment and after treatment. Compared with the adverse drug reactions that occurred during the study, Group 1 treated with phenyramidol alone showed a statistically significantly better safety profile than Group 2 treated with the combination of phenyramidol and diclofenac (p<0.001). As a result, it was observed that oral phenyramidol treatment alone and oral phenyramidol+diclofenac combination treatment did not have any difference in terms of efficacy, but when compared in terms of side effects, the use of phenyramidol alone showed a higher safety profile.

Keywords: phenyramidol, diclofenac, muscle spasm, spinal pain

Keywords:

phenyramidol, diclofenac, muscle spasm, spinal pain

DOI

https://doi.org/10.22270/jddt.v12i4-S.5512

Author Biographies

Halil Koyuncu, Department of Physical Therapy and Rehabilitation, Faculty of medicine, Acıbadem Hospital, Turkey

Department of Physical Therapy and Rehabilitation, Faculty of medicine, Acıbadem Hospital, Turkey 

Safak Sahir Karamehmetoglu, Department of Physical Therapy and Rehabilitation, Emsey Hospital, Turkey

Department of Physical Therapy and Rehabilitation, Emsey Hospital, Turkey 

Fatmanur Otmar Ozcan, Department of Internal Medicine, Okmeydani Training and Research Hospital, Turkey

Department of Internal Medicine, Okmeydani Training and Research Hospital, Turkey 

Kubra Saygisever-Faikoglu, Department of Pharmacology, Faculty of Pharmacy, Kocaeli Health And Technology University, Turkey

Department of Pharmacology, Faculty of Pharmacy, Kocaeli Health And Technology University, Turkey 

Gokhan Faikoglu, Department of Pharmaceutical Toxicology, Faculty of Pharmacy, Kocaeli Health And Technology University, Turkey

Department of Pharmaceutical Toxicology, Faculty of Pharmacy, Kocaeli Health And Technology University, Turkey 

Yurdaer Ozcan, Department of Internal Medicine, Bayrampaşa Public Hospital, Turkey

Department of Internal Medicine, Bayrampaşa Public Hospital, Turkey 

Tugce Uskur, Department of Medical Pharmacology, Faculty of medicine, Beykent University, Turkey

Department of Medical Pharmacology, Faculty of medicine, Beykent University, Turkey  

References

Torstensen TA., Ljunggren AE., Meen HD., et al. Efficiency and Costs of Medical Exercise Therapy, Conventional Physiotherapy, and Self-Exercise in Patients With Chronic Low Back Pain. Spine (Phila Pa 1976) 1998; 23:2616–24. https://doi.org/10.1097/00007632-199812010-00017.

Borenstein DG. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol 2001; 13:128–34. https://doi.org/10.1097/00002281-200103000-00006.

Frank JW., Brooker AS., DeMaio SE., et al. Disability resulting from occupational low back pain. Part II: What do we know about secondary prevention? A review of the scientific evidence on prevention after disability begins. Spine (Phila Pa 1976) 1996; 21:2918–29. https://doi.org/10.1097/00007632-199612150-00025.

Frank JW., Kerr MS., Brooker AS., et al. Disability resulting from occupational low back pain. Part I: What do we know about primary prevention? A review of the scientific evidence on prevention before disability begins. Spine (Phila Pa 1976) 1996; 21:2908–17. https://doi.org/10.1097/00007632-199612150-00024.

Mancao BD., Lorenzana GG., Perez MLP., et al. A Dose-finding Therapeutic Trial on Tizanidine in Filipinos with Acute Muscle Spasm. Philipp J Intern Med 1994:141–5.

Patel HD., Uppin RB., Naidu AR., et al. Efficacy and Safety of Combination of NSAIDs and Muscle Relaxants in the Management of Acute Low Back Pain. Pain Ther 2019; 8:121–32. https://doi.org/10.1007/S40122-019-0112-6.

Van Tulder MW., Koes BW., Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine (Phila Pa 1976) 1997; 22:2128–56. https://doi.org/10.1097/00007632-199709150-00012.

Van Tulder MW., Touray T., Furlan AD., et al. Muscle Relaxants for Nonspecific Low Back Pain: A Systematic Review within the Framework of the Cochrane Collaboration. Spine (Phila Pa 1976) 2003; 28:1978–92. https://doi.org/10.1097/01.BRS.0000090503.38830.AD.

Shah H., Shakeel A., Karne N., et al. Phenyramidol in Acute Conditions of Lumbago, Integumental Pain and Musculo-skeletal Pain: An Open Label, Noncomparative, Multi-center Study. Open Access J Clin Trials 2011; 3:27–33. https://doi.org/10.2147/OAJCT.S18505.

Miller LD. The distribution, metabolism, and excretion of phenyramidol in the dog. Toxicol Appl Pharmacol 1962; 4:190–9. https://doi.org/10.1016/0041-008X(62)90057-1.

Lipertz, S.J., Malanga AG. Oral Medications in the Treatment of Acute Low Back Pain. Occup Med J 1998; 13:151–66.

Van Tulder MW., Scholten RJPM., Koes BW., et al. Nonsteroidal Anti-Inflammatory Drugs for Low Back Pain. Spine (Phila Pa 1976) 2000; 25:2501–13. https://doi.org/10.1097/00007632-200010010-00013.

Tüzün F., Ünalan H., Öner N., et al. Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain. Jt Bone Spine 2003; 70:356–61. https://doi.org/10.1016/S1297-319X(03)00075-7.

Sheth S., Thakur S., Thorat A., et al. Safe and appropriate use of diclofenac in chronic kidney disease: An Indian perspective. J Fam Med Prim Care 2021; 10:2450. https://doi.org/10.4103/JFMPC.JFMPC_2358_20.

Food and Drug Administration (FDA)., Center for Drug Evaluation and Research(CDER)., Novartis Pharmaceutical Corporation. VOLTAREN ® (diclofenac sodium enteric-coated tablets). Novartis Pharm Corp 2009.

Atzeni F., Masala IF., Sarzi-Puttini P. A Review of Chronic Musculoskeletal Pain: Central and Peripheral Effects of Diclofenac. Pain Ther 2018; 7:163–77. https://doi.org/10.1007/S40122-018-0100-2.

Deseai AA., Sachdeva P., Arora B. A Comparative Study of Combined Use of Aceclofenac Along with Thiocolchicoside and Aceclofenac Alone in Patients Diagnosed of Low Back Pain. International Journal of Pharmacy and Pharmaceutical Sciences. Available at: https://www.semanticscholar.org/paper/A-COMPARATIVE-STUDY-OF-COMBINED-USE-OF-ACECLOFENAC-Desai-Sachdeva/9705cfe7b9f0fa4ebfd391a214923d44a98598d1. Accessed June 30, 2022.

Cabitza P., Randelli P. Efficacy and Safety of Eperisone in Patients with Low Back Pain: A Double Blind Randomized Study . Eur Rev Med Pharmacol Sci 2008; 12:229–35.

Elaine Allen I., Seamen C. Statistics Roundtable: Likert Scales and Data Analyses . Qual Prog 2007; 40:64–5.

Rentz LE. An Adjuvant Manipulative Therapy:Phenyramidol Injectable. J AOA 1962; 62:211–5.

Koyuncu H., Erden GM., Eşen S., et al. Akut Ağrılı Spinal Kas Spazmlarında Feniramidol ve Tiyokolşikosidin Güvenlik ve Etkinliğinin Karşılaştırılması Açık Çalışma. Dirim Tıp Gazetesi 2008; 34–9.

Published

2022-08-15
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How to Cite

1.
Koyuncu H, Karamehmetoglu SS, Ozcan FO, Saygisever-Faikoglu K, Faikoglu G, Ozcan Y, et al. Comparison of the Efficiency and Safety of Oral Phenyramidol and Phenyramidol+Diclofenac Treatment in Muscle Spasms with Spinal Pain – Open-Label Study. J. Drug Delivery Ther. [Internet]. 2022 Aug. 15 [cited 2026 Jan. 14];12(4-S):83-6. Available from: https://www.jddtonline.info/index.php/jddt/article/view/5512

How to Cite

1.
Koyuncu H, Karamehmetoglu SS, Ozcan FO, Saygisever-Faikoglu K, Faikoglu G, Ozcan Y, et al. Comparison of the Efficiency and Safety of Oral Phenyramidol and Phenyramidol+Diclofenac Treatment in Muscle Spasms with Spinal Pain – Open-Label Study. J. Drug Delivery Ther. [Internet]. 2022 Aug. 15 [cited 2026 Jan. 14];12(4-S):83-6. Available from: https://www.jddtonline.info/index.php/jddt/article/view/5512

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