Pregabalin Treatment for Trigger Points

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Pregabalin Treatment for Trigger Points in Patients With Comorbid Myofascial Pain Syndrome and Fibromyalgia Syndrome: a Randomized Controlled Trial

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Drug: Pregabalin 150mg


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Patients received pregabalin (target dose 300 mg/day) and exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months | Drug: Pregabalin 150mg<br>* Patients in group I received pregabalin at a dose of 75 mg twice daily during the first week that was increased to 150 mg twice daily thereafter and maintained at that level for 12 weeks. Patients in two groups received exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months<br>|
| No Intervention: Group 2<br>Patients received exercise therapy alone (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | VAS is psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in each patient and use this to achieve a rapid classification of symptom severity and disease control. Patients were instructed to rate their pain between 0 and 10 | 3 months | 
| Pressure pain thresholds (PPT) assessment | We assessed PPTs in upper trapezius trigger points with an algometer in all patients. PPT is defined as the minimal amount of pressure required to change a sensation of pressure to pain. An electronic algometer (Baseline Push Pull Force Gauge) was used, which consisted of a metal piston with a 1-cm circular rubber tip. Pressure measurements were recorded as kilograms per square centimeter (kg/cm2) with the patient in a seated position. The algometer was placed at a selected trigger point with the metal rod perpendicular to the surface of the skin, the pressure applied to the muscles was increased at a rate of approximately 1 kg per second, and the patient was instructed to state when pain was perceived. This procedure was repeated three times per patient, with 1-minute intervals. The mean of three trials (intra-examiner reliability) was calculated and used for the main analysis. If trigger points were in both upper trapezius muscle, the dominant side was evaluated. | 3 months | 
| DN4 - Questionnaire (DN4) | DN4 was used to evaluate neuropathic pain. DN4 is used to identify neuropathic pain and consists of ten questions. Seven questions are concerned with symptoms and three are concerned with clinical findings. Symptoms assessed are burning, painful cold, electric shocks, tingling, pins and needles, numbness, and itching. The physician assesses whether there is reduced sensation (hypoesthesia) to touch or pinprick, and if light brushing increases or causes pain (allodynia) by examination. Each item is scored yes (1 point) or no (0 points). If the total score is ≥4, the pain is likely to be neuropathic | 3 months | 
| Short Form-36 (SF36) | The SF36 is a self-reported questionnaire widely used to measure quality of life. The questions are summarized into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. The initial four items form the physical component summary measuring physical health domains, while the latter four items form the mental component summary measuring mental health domains. Scores can range from 0 (worst health status) to 100 (best health status) per domain. Higher scores indicate better health status for the calculated sub item | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibromyalgia, trigger point, myofascial pain, pregabalin