Neck PainNCT00042276
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
An observational study of Neck Pain, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2002to 15 Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- Subjects who have an inoordinate fear of needles.
- HEENT infections.
- Cancer.
- Knee pain.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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:
- healthy subjects without neck pain and who have no MTrPs identified by palpation bilaterally in GB-21, and who have no MTrPs identified by palpation bilaterally in LV-7,
- healthy subjects without neck pain in whom latent MTrPs are identified by palpation in GB-21 in one of the upper trapezius muscles, and who have no MTrPs indentified by palpation bilaterally in LV-7,
- healthy subjects complaining of neck pain of less than 3 months duration with active MTrPs identified by palpation in GB-21 in one of the upper trapezius muscles, and who have no MTrPs identified by palpation bilaterally in LV-7.
- Conditions
- Neck Pain
- Keywords
- Pressure Pain Threshold, MTrP, Musculoskeletal Pain, Soft Tissue Pain, Pathophysiology, Myofascial Pain, Microdialysis, Myofascial Trigger Points, Rehabilitation, Muscle Pain, Neck Pain, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Neck Pain, Musculoskeletal Pain, Myalgia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2002 (estimated)
- Study start14 Jul 2002
- Study completion15 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jay P Shah, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042276
- Sponsor's protocol ID
- 020245
- Other IDs
- 02-CC-0245
- Status last verified
- 15 Mar 2013
- First submitted
- 26 Jul 2002
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
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.
PubMed 7833584Hong CZ. Pathophysiology of myofascial trigger point. J Formos Med Assoc. 1996 Feb;95(2):93-104.
PubMed 9064014Bohr 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.
PubMed 8618650
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00042276
- Acronym / sponsor ID
- 020245
- Conditions
- Neck Pain
- Keywords
- Pressure Pain Threshold, MTrP, Musculoskeletal Pain, Soft Tissue Pain, Pathophysiology, Myofascial Pain, Microdialysis, Myofascial Trigger Points
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 14 Jul 2002
- Study completion
- 15 Mar 2013
- First posted
- 26 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- healthy subjects without neck pain and who have no MTrPs identified by palpation bilaterally in GB-21, and who have no MTrPs identified by palpation bilaterally in LV-7,
- healthy subjects without neck pain in whom latent MTrPs are identified by palpation in GB-21 in one of the upper trapezius muscles, and who have no MTrPs indentified by palpation bilaterally in LV-7,
- healthy subjects complaining of neck pain of less than 3 months duration with active MTrPs identified by palpation in GB-21 in one of the upper trapezius muscles, and who have no MTrPs identified by palpation bilaterally in LV-7.
Study design
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (26 listed)
- Fibroymaylgia.
- Cervical radiculopathy.
- Lumbro-sacral radiculopathy.
- Atypical facial neuralgia.
- History of trigger point injections in the upper trapezius muscle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 7833584Quintner 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.
- Background: PubMed 9064014Hong CZ. Pathophysiology of myofascial trigger point. J Formos Med Assoc. 1996 Feb;95(2):93-104.
- Background: PubMed 8618650Bohr 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.
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay P Shah, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00042276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.