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

NCT00635037 | Completed DMC

• 2 other identifiers: ACP myofascialNo grant
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myofascial Pain Syndromes

Keywords

Myofascial pain syndrome; Acupuncture; Nonsteroidal anti-inflammatory agents; Muscle relaxants, central; Quality of life.; muscle relaxants, analgesia

Outcome Measures

Primary Outcomes (1)

• Pain relief

  1year

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

A

EXPERIMENTAL

G1 (n=15)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(n=15) was submitted to classical and trigger point acupuncture twice a week.

Drug: bupivacaine and acupuncture

Interventions

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

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Pain Setor of Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Muscle Hypotonia; Agnosia

Interventions

Bupivacaine; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Complementary Therapies; Therapeutics

Study Officials

• Miriam CB Gazi, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: June 1, 2004
• Primary Completion: February 1, 2005
• Study Completion: November 1, 2006
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

BR (1)