Clinical trial NCT04600037: Pregabalin Treatment for Trigger Points
Official title: Effectiveness of Pregabalin Treatment for Trigger Points in Patients With Comorbid Myofascial Pain Syndrome and Fibromyalgia Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: fibromyalgia, trigger point, myofascial pain, pregabalin
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Myofascial pain syndrome (MPS) is a common problem in the general population. MPS should not be a local/peripheral painful syndrome and considered to be a syndrome of central sensitivity. We aimed to investigate the effect of pregabalin in patients with MPS in this study

Detailed description: We randomized 40 patients into two groups, and 17 patients per group completed the study. Patients in group I received pregabalin and exercise therapy, whereas those in group II received exercise therapy alone. All patients were evaluated as follows: for pain by VAS; trigger-point pressure pain threshold-(PPT) by algometry; neuropathic pain using DN4 and quality of life with the SF36. Evaluations were performed pretreatment and at the end of the first and third months of treatment.

Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed fibromyalgia syndrome,
* Patients who were also diagnosed as cervical myofascial pain syndrome based on the upper trapezius muscle

Exclusion Criteria:

* Patients who had received dry needling or local anesthetic injection to trigger point in the dominant upper trapezius muscle within 3 months of the start of the study.
* renal insufficiency,
* impaired liver function,
* malignancy,
* pregnancy
* infections,
* history of drug or alcohol abuse

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 3 months
measure: Pressure pain thresholds (PPT) assessment
timeFrame: 3 months
measure: DN4 - Questionnaire (DN4)
timeFrame: 3 months
measure: Short Form-36 (SF36)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Duygu Silte Karamanlioglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haydarpaşa Numune Training and Research Hospital
name: Duygu Geler Kulcu, prof
role: STUDY_DIRECTOR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Gulcan Ozturk, MD
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Pinar Akpinar, Assoc prof
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Feyza Unlu Ozkan, Assoc prof
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Ilknur Aktas, Prof
role: STUDY_CHAIR
References:
citation: Karamanlioglu DS, Geler Kulcu D, Ozturk G, Akpinar P, Unlu Ozkan F, Aktas I. Effectiveness of pregabalin treatment for trigger points in patients with comorbid myofascial pain syndrome and fibromyalgia syndrome: a randomized controlled trial. Somatosens Mot Res. 2021 Dec;38(4):327-332. doi: 10.1080/08990220.2021.1977265. Epub 2021 Sep 20.