An interventional study of Dry needling and Sham dry needling in Myofascial Trigger Point Pain and Myofascial Pain Syndrome, sponsored by Brigham Young University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Brigham Young University · Not applicable, Interventional, and Treatment
Among 36 studies in Myofascial Pain Syndromes with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Myofascial Pain Syndromes · United States.
Among the 36 studies in Myofascial Pain Syndromes with a site in United States, this one is the 22nd largest by enrollment of the 31 interventional ones that give a count, is one of 5 that started in 2016, is one of 16 with no phase, and was the 13th registered.
339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.
Browse Myofascial Pain Syndromes studies →8 of the 36 studies in Myofascial Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:
University of California, Davis · Sites in United States
Beth Israel Deaconess Medical Center · Sites in United States
Mayo Clinic · Sites in United States
Weill Medical College of Cornell University · Sites in United States
University of Arizona · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 34 Myofascial Pain Syndromes studies recruiting now, 5 (15%) set no upper age limit and 26 (76%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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36 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 5 started in 2016.
This study's enrollment of 20 is below the median of 50 across 307 interventional studies indexed under Myofascial Pain Syndromes.
Median enrollment 50 across the 31 interventional studies, 90 across the 5 observational. Of the 23 that completed or were terminated, 10 (43%) have results posted.
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3 of 36 have an industry lead sponsor. The 10 most frequent:
Brigham Young University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Brigham Young University has 2 studies filed under Myofascial Pain Syndromes — fewer than ten, so there is no comparison to draw.
3 of the studies in Myofascial Pain Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04732507University of ArizonaInvestigating the Minimum Number of Needling Required to Optimize Trigger Point Injections Outcome | 2026-12-09 |
| NCT07832422Nova Southeastern UniversityIschemic Compression and Low-Level Laser Therapy for Myofascial Low Back Pain | 2027-03 |
| NCT07278570Mayo ClinicMagnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain | 2027-08-30 |
Among the 36 studies in Myofascial Pain Syndromes with a site in United States, from their registry updates:
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Dry Needling (DN) is a skilled intervention that uses acupuncture filiform needles that are inserted into myofascial trigger points or other tissues underneath the skin. It is used to treat myofascial or neuromusculoskeletal pain and to improve movement impairments. Although more and more physical therapists add this treatment tool to their skill box, there is uncertainty about its working mechanism and its efficacy. The latter is partially due to the challenging task of finding and using a true control or sham treatment. The investigators will use blunted needles, which will not perforate the skin, as sham treatment.
This study will assess if DN of a trigger point in the gluteal muscles increases pain pressure threshold in that muscle, in another muscle innervated by the same segment (L4/5) and in an area not supplied by the same segment (i.e. the ipsilateral posterior shoulder). In addition, this study will assess if functionality, as measured by the Oswestry Disability Index (ODI) and 15-point Global Rating of Change Scale (GRoC) questionnaires, improves after 2-3 treatments (1 week) of DN.
Background Dry Needling (DN) is a skilled intervention that uses acupuncture filiform needles that are inserted into myofascial trigger points or other tissues underneath the skin [Dunning]. Trigger points are spots in taut muscle fibers that can produce local and radiating pain when irritated, for example when pressed upon. Several theories on the etiology of trigger points exist, such as a local energy crisis and increased acetylcholine release due to mechanical muscle overuse [Bron]. The existence of trigger points is widely accepted [Hong], although there are also some vocal opponents [Quintner 2015, Quintner 1994].
The aim of DN is to treat myofascial or neuromusculoskeletal pain and improve movement impairments. The mechanism which with DN purportedly works has been the subject of debate for many years. It is generally accepted that the needle has to be inserted into a trigger point, where it will produce a local muscle twitch response and consequently 'inactivate' the trigger point [Dunning]. Some propose that the quick muscle contraction induces normalization of tissue pH and reduction of biochemical and neurotransmitters that stimulate pain receptors - a local response [Shah]. Others suggest that DN interrupts the trigger point's ongoing nociceptive input into the dorsal horn - a segmental response [Fernandez-de-las-Penas]. Others again submit that, because some trigger points affect limbic and dorsal hippocampus activity, DN might have a central response [Niddam].
The efficacy of DN is also not completely clear, but shows a trend. One early literature review and meta-analysis concluded that DN was not significantly superior to placebo control in regards to pain decrease [Tough]. However, since then several systematic reviews with meta-analyses [Tekin, Kietrys, Boyles] determined that the evidence suggested that DN for trigger point-derived pain was likely to be the most effective approach, was superior in decreasing pain compared to stretching and percutaneous electric nerve stimulation and at least as effective as manual trigger point release and other needling treatments. One literature analysis supports the use of DN not only for its immediate, but also short-term effectiveness in reducing pain in patients with upper quarter myofascial pain syndrome [Kietrys].
Controlled trials that assess DN efficacy either use 1) sham or control (such as no or an inactive treatment) or 2) other treatments (such as lidocaine injections, non-local DN, or "usual care", such as stretching and exercise) for the comparison group. A blunted needle that does not penetrate the skin is a good sham treatment [Streitberger] and has been recommended as adequate control. As discussed elsewhere [Streitberger], every needle penetration, be it at a trigger point or not, will induce physiological responses and are as such not appropriate to use as control.
Srbely et al. found that one intervention of trigger point stimulation with DN evoked palliative effects in other areas innervated by the same spinal segment. They dry needled trigger points in the supraspinatus and assessed pressure sensitivity changes in the infraspinatus (same segment, C5) and gluteus maximus (different segment, L4/5, S1). Their results suggest that pain pressure threshold was increased after 3 and 5 minutes of DN in the areas supplied by the C5 segment, but not in the area supplied by L4/5, S1.
The above named study only assessed immediate pain-related changes due to the intervention and did not assess functional improvements. The investigators of this study were not able to find any articles investigating this phenomenon in the lower extremity. This project will use a similar set up as the above study, but the subjects will receive sham DN, not real DN in a non-trigger point tissue (which, as explained above, will still elicit physiological effects and could have some segmental influence) as in the above named study. In addition, the investigators will explore if there are functional improvements in subjects receiving DN. Consequently, the investigators propose to perform the following controlled study that explores the questions 'Does site specific trigger point dry needling evoke segmental neuromodulation in the lower extremity and if so, do these changes make an impact on the subject's disability?'.
The aims are:
I) Regarding Pain
II) Regarding Functionality
III) Regarding Mechanism
Our hypotheses are:
I)
II)
III)
Methods
Prospective subjects will undergo physical examination by the co-author PC to identify inclusion and exclusion criteria.
The main inclusion criterion will be the presence of a painful trigger point in the gluteals (gluteus maximus or medius) and infraspinatus on the same side. The painful trigger point is defined as a distinct hypersensitive taut band within a muscle that begins to radiate diffuse pain into adjacent areas with sustained pressure. In keeping with the study conducted by Srbely et al. the investigators will only include trigger points with a baseline (pre-intervention) pain pressure threshold (PPT) value of 35 N or less in order to improve reliability of their detection. The precise location of each trigger point will be marked on the skin using a non-toxic marker for ease of follow-up identification.
If the patient is deemed eligible for the study, the investigating PT will explain the study to the prospective subject and he/she will be asked if he/she wants to participate. The PT will explain that the subject might not get the actual DN technique, but instead a sham. If the subject declines he/she will receive treatment as 'normal'. If he/she agrees, he/she will receive the informed consent to read and sign. If there are study-related questions they will be answered. After this the subject will fill out an intake sheet for demographic information, the modified Oswestry Disability Questionnaire (mOSW) [Copay] as well as a pain map and visual analog scale (VAS) for low back pain. The subject will then determine his/her group allocation by drawing a piece of paper out of an opaque envelope. This envelope will contain 40 pieces of paper; 20 of them will specify 'dry needling A' (for treatment), 20 will specify 'dry needling B' (for sham).
The rest of the physical therapy treatment will be pragmatic; the subject will receive mobilizations (no grade 5: high velocity low amplitude), exercises as indicated and DN for one week (2-3 visits). Grade 5 mobilizations (or manipulations) will be excluded as treatment option because they are believed to elicit neurophysiological effects, similar to DN, and might skew the results.
Study flow/ data intake
Data Analysis
PPT readings will be normalized to baseline scores so the focus is on the percent changes, not on the absolute changes in values.
All significance levels will be set at 0.05. The minimally clinically important difference (MCID) for the VAS is 2 points [Childs], for the OSW it is 12.8 points [Copay] and the 'important improvement' for the GRoC is 5 points [Kamper].
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Trigger points found in the gluteal region of one side (e.g. right) will be dry needled; presence of muscle twitching (which would signify appropriate needle insertion) will be documented.
Procedure: Dry needling
Trigger points found in the gluteal region of one side (e.g. right) will be SHAM dry needled with blunted needles, no actual penetration through the skin will occur.
Other: Sham dry needling
Acupuncture filiform needles are inserted into myofascial trigger points
Also known as: Trigger point dry needling, intramuscular needling
Blunted needles will be pressed against the skin, but no actual penetration will occur
pressure sensitivity (pain pressure threshold)
Pain pressure threshold values as measured with algometer
Time frame: 1 week
Low back pain as measured with visual analog scale (VAS)
a 100 mm line with anchors on the left ('no pain') and on the right ('worst pain imaginable')
Time frame: 1 week
modified Oswestry Disability Questionnaire (mOSW)
A 10-item questionnaire assessing low back pain-related disability
Time frame: 1 week
15-point Global Rating of Change Scale (GRoC)
A single item questionnaire, where the patient has to quantify his/her improvement or deterioration over time by choosing one of 15 possible answers.
Time frame: 1 week
Plan to share: No — Data will not be shared with any other researcher
The record gives a start of Dec 2016, a primary completion of Aug 2023 and a completion of Aug 2023. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Brigham Young University