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Completed

NCT Number: NCT01520415

Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients

The objective of this study is to examine the short and long-term effect of myofascial trigger point injections with either a local anesthetic or saline in patients with chronic low back pain presenting with myofasical pain syndrome.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CLBP of non-malignant origin, with or without accompanying leg pain, including patients with history of previous back surgery or trauma
  • MPS as evident by at least one active MTP, located medial or lateral to the posterior iliac crest involving the gluteus maximus or medius, quadratus lumborum and erector spinae muscles
  • While not precluding the participation in the study, MTP in other areas will not make patients eligible
  • Pain lasting for at least six months

Exclusion criteria

  • Any current motor weakness, but not sensory loss or abnormal reflexes in the lower limbs
  • Any injection or nerve block in the low back in the last 6 months
  • Local or systemic infection
  • Bleeding disorder or the use of anticoagulation medications
  • Known allergy to local anesthetics
  • Poor understanding of written and spoken English or French

Treatment and study plan

Bupivacaine

Drug

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Other names: lidocaine

Saline

Drug

2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit

Primary outcomes

  1. Pressure pain threshold of the myofascial trigger points

    Time frame: 12 weeks

    Change in the pressure pain threshold will be measured using a pressure algometer.

Secondary outcomes

  1. Pressure pain threshold of MTPs

    Time frame: baseline, 4 weeks, 8 weeks

    Change in the pressure pain threshold of MTPs after each MTP injection.

  2. VAS Low Back Pain

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks

    Change in pain intensity after each MTPI and at the end of the study.

  3. Roland-Morris Disability Questionnaire (RDQ-20)

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks

    Change in disability levels after each MTPI and at the end of the study.

  4. Short-Form Health Status Survey 12 (SF-12)

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks

    Change in functional status, well-being and quality of life after each MTPI and at the end of the study.

  5. Consumption of analgesic medications

    Time frame: 12 weeks

    Change in the consumption of analgesic medications.

  6. Number of participants with Adverse Events

    Time frame: 12 weeks

    Adverse events resulting from the intervention.

Sponsors and collaborators

Lead sponsor

Dr. Yoram Shir

Other

Registry information

Official study title

A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2012
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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