The Natural History of Upper Trapezius Myofascial Trigger Points: Comparison of Local and Remote Tissue Milieu in Normal Muscle, Latent and Active Myofascial Trigger Points Over Time
|First Received Date ICMJE||July 26, 2002|
|Last Updated Date||May 23, 2013|
|Start Date ICMJE||July 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00042276 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Natural History of Upper Trapezius Myofascial Trigger Points: Comparison of Local and Remote Tissue Milieu in Normal Muscle, Latent and Active Myofascial Trigger Points Over Time|
|Official Title ICMJE||The Natural History of Upper Trapezius Myofascial Trigger Points: Comparison of Local and Remote Tissue Milieu in Normal Muscle, Latent and Active Myofascial Trigger Points Over Time|
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:
Preliminary data suggest that patients with active myofascial trigger points (MTrPs) have a significantly different biochemical profile within the local milieu of the MTrPs compared to those without MTrPs or those with a latent (non-symptomatic) MTrP. An important question to answer is whether anatomical loci, remote from active or latent MTrPs have similar biochemical profiles to the MTrP itself. These remote sites should be evaluated to help distinguish whether MTrPs have local biochemical profiles or are associated with a more widespread phenomenon.
We will select three groups of subjects based on the following characteristics [1, 2, 3 below]. We will sample GB-21 in the upper trapezius muscle and LV-7 (posterior and inferior to the medial condyle of the tibia in the upper portion of the medial gastrocnemius) standardized sites for pH, muscle metabolites, inflammatory mediators, arachidonic acid derivatives, neuropeptides, etc.
The goal of this study is to determine whether the local biochemical milieu of an active MTrP is the same as the biochemical milieu at anatomical sites remote from the MTrP.
The acupuncture points GB-21 and LV-7 are selected specifically to standardize the locations of a sampling point in three carefully selected groups:
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Neck Pain|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
Other concurrent pain syndromes.
On any NSAID, COX2 inhibitor, TCA, narcotic, antiepilectic, muscle relaxant, ancetaminophen or other medication for the purpose of pain relief.
Subjects who have an inoordinate fear of needles.
History of DVT.
History of Baker's Cyst.
History of Myopathy.
History of meniscal tear.
History of anterior cruciate ligament/posterior cruciate ligament/medial collateral ligament/lateral collateral ligament tear.
History of knee surgery.
History of Achilles pathology or rupture.
|Ages||21 Years to 65 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00042276|
|Other Study ID Numbers ICMJE||020245, 02-CC-0245|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2013|
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