Pregabalin Treatment for Trigger Points

NCT04600037 | Completed

• 1 other identifier: FSMEAH-KAEK 2014/20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Myofascial Pain Syndrome

Keywords

fibromyalgia, trigger point, myofascial pain, pregabalin

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

NO INTERVENTION

Patients received exercise therapy alone (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months

Interventions

Pregabalin 150mg DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34544324 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes; Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Duygu Silte Karamanlioglu, MD

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Duygu Geler Kulcu, prof

  Haydarpaşa Numune Training and Research Hospital

  STUDY DIRECTOR

• Gulcan Ozturk, MD

  Fatih Sultan Mehmet 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 23, 2020
• Study Start: April 26, 2014
• Primary Completion: July 26, 2014
• Study Completion: January 26, 2015
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)