A Phase 4 interventional study of Ropivacaine and Pregabalin in Myofascial Pain Syndrome - Neck, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by National and Kapodistrian University of Athens · Phase 4, Interventional, and Treatment
This study compared trigger point injections with ropivacaine alone versus trigger point injections combined with oral pregabalin in adults with chronic myofascial pain of the neck and upper back. Participants were randomly assigned to one of the two treatment groups. Pain intensity, number of trigger points, neuropathic pain symptoms, and health-related quality of life were assessed at baseline and at 1 and 3 months after treatment.
National and Kapodistrian University of Athens is the lead sponsor of 172 studies on the registry; 52 are open to participants now.
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Participants received trigger point injections with 0.2% ropivacaine, 2 mL per trigger point.
Drug: Ropivacaine
Participants received trigger point injections with 0.2% ropivacaine, 2 mL per trigger point, combined with oral pregabalin 50 mg twice daily.
Drug: Ropivacaine · Drug: Pregabalin
Ropivacaine 0.2%, administered as a 2 mL injection into each identified trigger point.
Pregabalin 50 mg administered orally twice daily.
Change in pain intensity measured by the Numerical Rating Scale (NRS)
Pain intensity was assessed using the 0-10 Numerical Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: Baseline, 1 month and 3 months after treatment
Change in the number of active trigger points
The number of clinically identified active trigger points in the neck and upper back was recorded during physical examination
Time frame: Baseline, 1 month, and 3 months after treatment
Change in neuropathic pain assessed using the DN4 questionnaire
The Douleur Neuropathique 4 Questions (DN4) questionnaire is a widely validated (including the greek population) clinician-administered screening tool designed to evaluate the presence of a neuropathic pain component in clinical trials. This tool measures sensory descriptors and clinical examination findings through a single, aggregated scale consisting of 10 binary items. The Douleur Neuropathique 4 Questions scale uses a binary scoring system with a minimum value of 0 and a maximum value of 10, where higher scores indicate a worse outcome (a higher probability and greater presentation of neuropathic pain features). By combining a 7-item patient interview with a 3-item bedside sensory examination, the DN4 provides a standardized, efficient method to identify neuropathic characteristics, with a score of 4 or higher serving as the established clinical threshold indicating a likely neuropathic pain component.
Time frame: Baseline, 1 month, and 3 months after treatment
Change in health-related quality of life assessed using the SF-12 questionnaire
Health-related quality of life was assessed using the 12-item Short Form Health Survey (SF-12). The 12-Item Short-Form Health Survey (SF-12) is a widely validated (including greek population), patient-reported instrument designed to evaluate health-related quality of life in clinical trials. This tool measures functional health across two primary domains: the Physical Component Summary scale and the Mental Component Summary scale. Both scales use a norm-based scoring system where the theoretical minimum value is 0 and the maximum value is 100 (standardized to a general population mean of 50 and a standard deviation of 10), where higher scores indicate a better outcome (superior physical or mental health-related quality of life).
Time frame: Baseline, 1 month, and 3 months after treatment
Insomnia
The incidence of insomnia will be documented with a simple question in each patients' chart "Do you experience insomnia? yes or no."
Time frame: Baseline and 3 months after treatment
Analgesic consumption
The incidence of the need of each patient to consume extra analgesic pills will be documented as a question in the patient's chart stating the type of analgesic (paracetamol or NSAIDs) and the frequency.
Time frame: Baseline and 3 months after treatment
Patient satisfaction
The patients' satisfaction from the treatment received will be assessed by a questionnaire from 0-3 where 0 means poor satisfaction, 1 average satisfaction, 2 good satisfaction and 3 excellent satisfaction.
Time frame: Baseline and 3 months after treatment
Plan to share: No — Individual participant data will not be shared because participant consent did not include public sharing of de-identified individual-level data.
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Dec 2025, 9 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pregabalin
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