Pregabalin Treatment for Trigger Points

NCT ID: NCT04600037

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-26

Study Completion Date

2015-01-26

Brief Summary

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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

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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.

Conditions

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Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type 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 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duygu Silte Karamanlioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet Training and Research Hospital

Duygu Geler Kulcu, prof

Role: STUDY_DIRECTOR

Haydarpaşa Numune Training and Research Hospital

Gulcan Ozturk, MD

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Pinar Akpinar, Assoc prof

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Feyza Unlu Ozkan, Assoc prof

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Ilknur Aktas, Prof

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Locations

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Fatih Sultan Mehmet Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34544324 (View on PubMed)

Other Identifiers

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FSMEAH-KAEK 2014/20

Identifier Type: -

Identifier Source: org_study_id