Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome

NCT04405453 | Completed

• 1 other identifier: DiskapiTRH Algology
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups. It is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle. Myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture. Trigger point injection is the application of low dose local anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused by muscle spasm.However, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.Trigger point injection can reach trigger points in superficial muscles With the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points. With this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.

Conditions

Trigger Point; Myofascial Pain

Keywords

Trigger point , Erector spinae plane block , Ultrasonography

Outcome Measures

Primary Outcomes (5)

• VAS (visual analog scale ) score

  Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.

  before injection (week 0)

• VAS (visual analog scale ) score

  Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.

  1st week after injection

• VAS (visual analog scale ) score

  Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.

  2nd week after injection

• VAS (visual analog scale ) score

  Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.

  3rd week after injection

• VAS (visual analog scale ) score

  Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.

  4th weeks after injection

Study Arms (2)

Trapezius Muscle İnjection (TMI) group

ACTIVE COMPARATOR

TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections

Procedure: trapezius muscle injection

Erector Spina Plane Block (ESPB) group

ACTIVE COMPARATOR

ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive. Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections

Procedure: trapezius muscle injection; Procedure: erector spina plane block

Interventions

trapezius muscle injection PROCEDURE

TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.

Erector Spina Plane Block (ESPB) group; Trapezius Muscle İnjection (TMI) group

erector spina plane block PROCEDURE

1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive

Erector Spina Plane Block (ESPB) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Myofascial pain

You may not qualify if:

• Cervical radiculopathy fibromyalgia

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Dişkapi Reserch and Education Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

• damla yürük

  Diskapi Teaching and Research Hospital

  PRINCIPAL INVESTIGATOR

• ömer taylan akkaya

  Diskapi Teaching and Research Hospital

  STUDY DIRECTOR

• Hüseyin Alp Alptekin

  Diskapi Teaching and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: One physician who will be blind will examinade all patients for eligibility and will valuate the outcome measures although the physician who will performe all injections will not be blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients with myofasial pain syndrome will randomized into two group. TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive. Pain severity of the patients will evaluate by visual analog scale. Datas will obtaine before (week 0) and after (week 1,2,3,4) the injections.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 28, 2020
• Study Start: June 1, 2020
• Primary Completion: July 5, 2020
• Study Completion: July 20, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 19.05.2020
• Access Criteria: NO CRİTERİA

Locations

TU (1)