Pregabalin Treatment for Trigger Points

October 22, 2020 updated by: Fatih Sultan Mehmet Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34752
        • Fatih Sultan Mehmet Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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

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
No Intervention: Group 2
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)
Time Frame: 3 months
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
Time Frame: 3 months
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)
Time Frame: 3 months
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)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Study Director: Duygu Geler Kulcu, prof, Haydarpasa Numune Training and Research Hospital
  • Study Chair: Pinar Akpinar, Assoc prof, Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: Feyza Unlu Ozkan, Assoc Prof, Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: ILKNUR AKTAS, Prof, Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2014

Primary Completion (Actual)

July 26, 2014

Study Completion (Actual)

January 26, 2015

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSMEAH-KAEK 2014/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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