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NCT Number: NCT00635037

Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine

CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain. The objective of the present study was to compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone.

DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty patients were divided into two groups: G1 received trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients were asked to continue physical exercise. The following parameters were evaluated: pain intensity rated on a numerical and verbal scale, quality of life before and four weeks after treatment, and quality of analgesia.

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Key information

Conditions

Myofascial Pain Syndromes Agnosia Muscle Hypotonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Setor of Federal University of Sao Paulo

São Paulo, Brazil

About this study

Among the 39 patients selected, nine (3 in group 1 and 6 in group 2) were excluded from the study because they did not attend the visits scheduled for the procedures and assessment or because they did not respond to the questionnaires.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- patients of both genders

  • chronic myofascial syndrome (duration of more than three months),
  • ranging in age from 18 to 65 year,
  • pain intensity score of 3 or higher (rated on a numerical scale ranging from 0 to 10)

Exclusion criteria

  • patients with disc herniation,
  • osteoarthritis,
  • vertebral collapse,
  • temporomandibular joint dysfunction,
  • infection, -
  • tumors,
  • coagulopathy, -
  • psychiatric disease,
  • cognitive disorders.
  • Patients who had used any type of analgesic or muscle relaxant agent 15 days before the study and those taking anticoagulants

Treatment and study plan

bupivacaine and acupuncture

Drug
  • trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h.
  • acupuncture twice a week

Primary outcomes

  1. Pain relief

    Time frame: 1year

Secondary outcomes

  1. compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine on Pain Relief of Patients With Myofascial Pain: Randomized Clinical Study

Acronym: ACP

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Mar 13, 2008
Registry last updated
Mar 13, 2008

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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