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

D

Dr. Yoram Shir

Status and phase

Completed
Phase 2

Conditions

Low Back Pain

Treatments

Drug: Saline
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01520415
AEPMU-01

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

bupivacaine
Active Comparator group
Treatment:
Drug: Bupivacaine
saline
Placebo Comparator group
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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