NCT00042276

Brief Summary

This study will use microdialysis to investigate myofascial pain. This pain is characterized by "trigger points" (exquisitely tender spots) in a group of tense muscle fibers that extend from the trigger point to the muscle attachments. Trigger points in the trapezius, a large muscle lying between the neck and shoulder, are typically caused by emotional stress, postures such as hunching shoulders, certain activities like using a telephone receiver without elbow support, or by wearing certain articles such as a heavy coat or heavy purse. Microdialysis uses a very thin needle probe (about the size and shape of an acupuncture needle) to collect and measure chemicals directly from soft tissue. Analysis of these chemicals will show whether changes in the tissue around a muscle with trigger points are confined to that muscle, or if these changes also occur in more distant muscles. The study will examine two types of trigger points. An "active" trigger point causes pain or other abnormal symptoms and often causes problems with movement. A "latent" trigger point often causes movement problems without causing pain. Many healthy adults have latent trigger points. People between 21 and 65 years of age with the following characteristics may be eligible for this study: 1) no neck pain or trigger points in either upper trapezius muscle; 2) no neck pain but a latent trigger point in at least one upper trapezius muscle; or 3) neck pain of less than 3 months' duration and an active trigger point in at least one upper trapezius muscle. Participants undergo the following procedures:

  • Physical examination of the muscles of the neck and shoulder area, testing strength and range of motion, and response to palpation to find trigger points.
  • Pain inventory. Subjects complete a questionnaire for measuring pain and its intensity, location, quality, causes, relievers, and associated symptoms. The questionnaire is filled in before and after each microdialysis procedure.
  • Microdialysis in upper trapezius muscle. An electrode patch is placed on either side of the site for insertion of the microdialysis probe and another electrode is placed on the outer edge of the shoulder. The electrodes are used to measure any electrical activity that occurs with insertion or movement of the probe. The subject lies face down and the probe is inserted in the upper trapezius muscle. It remains in place for 5 minutes while chemical substances are collected from the muscle. It is then advanced about 1.5 cm deeper into the muscle until a twitch response is obtained and remains in place for 10 more minutes while substances are collected.
  • Microdialysis in the gastrocnemius muscle (large muscle of the calf). The same procedure for the upper trapezius muscle is done in the calf muscle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2002

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2002

Completed
Same day until next milestone

First Posted

Study publicly available on registry

July 26, 2002

Completed
10.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2013

Completed
Last Updated

October 6, 2017

Status Verified

March 15, 2013

First QC Date

July 26, 2002

Last Update Submit

October 5, 2017

Conditions

Keywords

Pressure Pain ThresholdMTrPMusculoskeletal PainSoft Tissue PainPathophysiologyMyofascial PainMicrodialysisMyofascial Trigger PointsRehabilitationMuscle PainNeck PainHealthy VolunteerHVNormal Control

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A total of 24 adults are expected to be accrued (8 in each group; Normal, Latent and Active) ages 18-65, without pain and those with continuous idiopathic cervical pain of less than 3 months duration.

You may not qualify if:

  • Fibroymaylgia.
  • Cervical radiculopathy.
  • Lumbro-sacral radiculopathy.
  • Atypical facial neuralgia.
  • History of trigger point injections in the upper trapezius muscle.
  • History of cervical spine or shoulder surgery.
  • History of previous trigger point injections in the medial gastrocnemius muscle.
  • History of below the knee or above the knee amputation.
  • History of total knee arthroplasty.
  • History of bleeding disorder.
  • Subjects on anticoagulation therapy.
  • If the subject has taken aspirin within 3 days of needling.
  • Tobacco smokers.
  • Other concurrent pain syndromes.
  • On any NSAID, COX2 inhibitor, TCA, narcotic, antiepilectic, muscle relaxant, ancetaminophen or other medication for the purpose of pain relief.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Quintner JL, Cohen ML. Referred pain of peripheral nerve origin: an alternative to the "myofascial pain" construct. Clin J Pain. 1994 Sep;10(3):243-51. doi: 10.1097/00002508-199409000-00012.

    PMID: 7833584BACKGROUND
  • Hong CZ. Pathophysiology of myofascial trigger point. J Formos Med Assoc. 1996 Feb;95(2):93-104.

    PMID: 9064014BACKGROUND
  • Bohr T. Problems with myofascial pain syndrome and fibromyalgia syndrome. Neurology. 1996 Mar;46(3):593-7. doi: 10.1212/wnl.46.3.593. No abstract available.

    PMID: 8618650BACKGROUND

MeSH Terms

Conditions

Neck PainMusculoskeletal PainMyalgia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Jay P Shah, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 26, 2002

First Posted

July 26, 2002

Study Start

July 14, 2002

Study Completion

March 15, 2013

Last Updated

October 6, 2017

Record last verified: 2013-03-15

Locations