Dry NeedlingNCT05596240
Dry Needling and Shoulder Muscle Blood Flow, Motions, and Pain Sensitivity in Individuals with Shoulder Pain
A study testing Dry Needling in people with Dry Needling and Shoulder Pain, run by Texas Woman's University at 1 site in United States.
Trial summary
Shoulder pain is one of the most common reasons people consult with their primary health care provider, and 40-50% of these patients with shoulder pain continued to complain of persistent symptoms after 6 to 12 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Needling, Shoulder Pain
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2022to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65 with unilateral nonspecific shoulder pain based on participants' self-reported pain level of greater than or equal to 2/10 on the Numeric Pain Rating Scale (NPRS) in last 24 hours
- non-traumatic origin of pain
- presence of at least one MTrP with referral pain pattern in the infraspinatus muscle determined through palpation.
Who cannot join
- systemic joint disease (e.g. rheumatoid arthritis)
- evidence of red flags (e.g. signs of current fracture or history of fracture to scapula, glenoid or proximal humerus, infection, tumor, incontinence, or paresthesias)
- cancer
- neurological disorders
- neuropathy
- Raynaud's disease
Show all 13Show fewer
- pregnancy
- previous shoulder surgery
- repeated infection (e.g. systemic infection, red skin, fever, individuals who are visibly unwell or toxic in appearance)
- immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
- inability to maintain the testing and treatment positions (i.e., supine and prone-lying) for 15 minutes at a time.
- bleeding disorders (e.g. hemophilia)
- use of anti-coagulants (e.g. vitamin K antagonists, direct oral anticoagulants, and low molecular weight heparins)
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Woman's University T. Boone Pickens Institute of Health Sciences - Dallas Center
Dallas, Texas, 75235
About this study
Official title: The Effects of Dry Needling on Muscle Blood Flow of the Infraspinatus in Individuals with Shoulder Pain - a Randomized Controlled Trial
Shoulder pain is one of the most common reasons people consult with their primary health care provider, and 40-50% of these patients with shoulder pain continued to complain of persistent symptoms after 6 to 12 months. It has been suggested that the presence of myofascial trigger points (MTrPs) may contribute to the chronicity of shoulder symptoms. An MTrP is a hyperirritable taut band of tissue within a muscle that produces pain when stimulated MTrPs are common in patients with shoulder disorders and occur most often in the infraspinatus muscle of a painful shoulder MTrPs were associated with an acidic biochemical environment with elevated levels of inflammatory mediators, neuropeptides, and proinflammatory cytokines such as bradykinin and calcitonin g-related peptide. It was hypothesized that metabolic demands on muscle and capillary constrictions may contribute to the development of MTrPs. To date, only a few studies have examined the vascular environment of MTrPs and surrounding areas before and after dry needling. No studies have yet examined whether dry needling would change blood flow in patients with shoulder pathology. Therefore, the purpose of this pilot study is to examine the effect of dry needling on blood flow of the infraspinatus muscle using color Doppler imaging in individuals with shoulder pain. The secondary purpose is to examine the effect of DN on shoulder motion and sensitivity to pressure in individuals with shoulder pain.
Read the detailed description
RESEARCH DESIGN This pilot study will be a single-blinded randomized comparison trial with two groups: (1) the group that will receive real DN, and (2) a placebo group that will receive sham DN. The research design will be a prospective two-way (2 x 2) mixed design to examine the effects of DN on blood flow (i.e., peak systolic velocity, end diastolic velocity, resistive index, pulsatile index) of the infraspinatus, shoulder range of motionss of internal rotation and external rotation, and PPTs of the infraspinatus. The two independent variables are: (1) group with two levels (DN and sham DN groups), and (2) time with two levels (baseline and immediately after the intervention) for the peak systolic velocity, end diastolic velocity, resistive index, pulsatile index of the infraspinatus, shoulder internal rotation, shoulder external rotation, and PPTS of the infraspinatus.
INSTRUMENTATION A color-Doppler ultrasonographic scanner and a curvilinear transducer (Sonosite Edge; Sonosite, Inc., Bothell, WA) will be used to measure blood flow of the infraspinatus muscle. The curvilinear probe (5-2MHz) has ability to capture images up to 30 cm in depth. A standard goniometer with 1° increments will be used to measure shoulder ROMs. Standard goniometric measurements have shown good-to-excellent reliability for shoulder internal and external ROMs.23 A hand-held computerized pressure algometer (Medoc ltd., Ramat Yishai, Israel) will be used to measure the PPT over the infraspinatus muscle. The algometer consists of a 1 cm2 round-tip that will be pressed perpendicular to the skin of the infraspinatus muscle at a rate of 40kPa/s until the first perception of pain or discomfort detected by the participant. The participant will be able to stop the test with a press of a button upon feeling the first sensation of pain or discomfort. This device has shown to have high test-retest reliability (intraclass correlation coefficients = 0.70-0.94) in the shoulder and neck muscles.
PROCEDURE At the beginning of the visit, all participants will be asked for demographic information and their pain-related characteristics, including location, duration, intensity at onset, and intensity currently, at best, and at worst in the previous 24-hours using the NPRS. After the subjective information is gathered, an investigator will assess for the presence of MTrP based on palpation. The participant will be placed in the prone position with arms resting at their side. The examiner will palpate the infraspinatus muscle belly for the presence of a taut band, a hypersensitive spot, and reproduction of the participants symptoms.11 Al-Shenqiti and Oldham25 demonstrated high reliability (k=0.86) with palpation for the presence or absence of the taut band, spot tenderness, and/or referred pain sensation.
Once the participant is determined eligible, they will be asked to complete the Quick Disability of Arm Shoulder Hand (QuickDASH) questionnaire to determine their self-reported disability and function (Appendix C).26 Next, the three outcome measures will be collected, including blood flow parameters, shoulder ROMs, and PPTs. If the participant has bilateral shoulder pain, the most painful shoulder will be tested. If both shoulders are equally painful, a coin-flip will be used to determine the side on which testing will be performed. The outcome measurements will be administered in an order of shoulder ROMs, followed by PPT and blood flow parameters before the DN intervention. Following the intervention, the outcome measurements will be collected in a reverse order of blood flow parameters, PPT, and shoulder ROM to minimize the position changes and to capture immediate changes of blood flow. These outcomes will be assessed by an investigator blinded to the intervention assignment.
SHOULDER RANGE OF MOTION ROM testing will be performed while the participant is lying supine with the shoulder at 90° abduction and 10° of horizontal abduction and elbow at 90°flexion. The examiner will be responsible for all the measurements. The center of rotation of the goniometer will be placed over the olecranon while one arm of the goniometer will be positioned along the length of the ulna, aligned with the ulnar styloid process. The other arm will be positioned perpendicular to the ground. For both measurement of internal and external rotation, scapular compensation will be monitored by using the thumb on the coracoid process and fingers along the spine of the scapula. Each measurement will be repeated three times with the average measurements used for data analysis.
PRESSURE PAIN THRESHOLD MEASUREMENT During the PPT testing, the participant will be placed in the prone position with upper extremities relaxed at their sides. PPT of the infraspinatus muscle will be tested in the muscle belly 1.5 inches below the midpoint of the spine of scapula. The participants will be given a stop button and will be instructed to stop the test as soon as the pressure becomes uncomfortable or painful, and not to allow a painful or uncomfortable sensation to continue. The participants will be familiarized with the algometer, which will consist of a single trial on the non-painful side to ensure that the participant understands the process. A total of three trials will be performed and the average of three trials will be used for data analysis. The PPT of the infraspinatus muscle has been shown to have good-to-excellent intraday, interday, intrarater, and interrater reliability.27,28
ULTRASOUND IMAGING Each participant will remain in the same position for ultrasound imaging. The ultrasound transducer will be placed perpendicular to the infraspinous fossa to visualize arterioles or arteries in the vicinity of the MTrPs and to quantify the velocity of flow at the MTrPs of the infraspinatus. The location of the transducer will be outlined after initial placement to ensure consistent placement of the transducer between trials as well as before and after DN. The spectral Doppler waveforms will be analyzed to trace the velocities throughout the cardiac cycle. The peak systolic (PSV), end diastolic velocity (EDV), resistive index (RI), and pulsatile index (PI) will be calculated using software available on the device. On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window, whereas the EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV and the PI with the formula PI = (PSV EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle. A reliability study is currently underway to establish the test-retest reliability of this ultrasound testing protocol (TWU IRB # IRB-FY2022-349).
INTERVENTION Following the baseline testing, the participants will be randomly assigned to either the real DN group or sham DN group. A large opaque envelope containing 40 cards, 20 cards marked "DN" and 20 marked "sham DN" will be used for random assignment. Each participant will be randomly assigned based on the card drawn from the envelope. The group assignment will be performed by the treating physical therapist. If a participant withdraws from the study, a card for the group to which they are assigned will be returned to the envelope.
For the real DN group, the technique described by Hong14 will be used to needle the two to four MTrPs in the infraspinatus muscle based on the results of the examiner's palpation. A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the MTrP of the infraspinatus muscles. Once the needle has been inserted, the needle will be pistoned in an up-and-down motion within the infraspinatus muscle at approximately 1Hz for 10 seconds with the aim of eliciting local twitch responses.
Streitberger Placebo-needles (Asia-med, Las Vegas, NV) will be used to perform the intervention for participants in the sham DN group. These needles have been reported to be indistinguishable from real needles. The device consists of a plastic tube with a blunted tip needle that allows for the sensation of a prick without penetrating the skin. The sham needle produces a sensation, which causes the participant to feel as if the needle enters the skin, while maintaining similar patient-therapist contact time and total intervention time.29
REASSESSMENT Immediately following the intervention, the three outcomes will be collected from all participants in the following order to minimize position changes: blood flow parameters, PPT, and shoulder ROMs. Additionally, any adverse events, such as bruising, nausea, dizziness, or post-needling soreness following the dry needling procedures will be assessed immediately. If bleeding occurs, the participant will be informed.
- Conditions
- Dry Needling, Shoulder Pain
- Being tested
- Dry Needling, Sham Dry Needling
- Keywords
- dry needling, shoulder pain, pain pressure threshold
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the MTrP of the infraspinatus muscles. Once the needle has been inserted, the technique described by Hong (1994) will be used. The needle will be pistoned in an up and down motion within the infraspinatus muscle at approximately 1Hz for 10 seconds with the aim of eliciting local twitch responses.
Sham Dry NeedlingOther
Streitberger Placebo-needles (Asia-med, Las Vegas, NV) will be used to perform the intervention for participants in the sham DN group. These needles have been reported to be indistinguishable from real needles. The device consists of a plastic tube with a blunted tip needle that allows for the sensation of a prick without penetrating the skin. The sham needle produces a sensation, which causes the participant to feel as if the needle enters the skin, while maintaining similar patient-therapist contact time and total intervention time.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | Individuals with shoulder pain will receive dry needling to the two to four most tender points in the infraspinatus based on examiner palpation Receives: Other: Dry Needling |
| Sham Dry Needling | Placebo comparator | Individuals with shoulder pain will receive sham dry needling to two points in the muscle belly of the infraspinatus near the insertion and below the midpoint of the spine of the scapula Receives: Other: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Systolic Velocity
On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV.
Measured: Change from baseline PSV immediately
Resistive Index (RI)
Resistive Index is used to assess the resistance in a pulsatile vascular system.The RI is defined by the the formula RI = (PSV - EDV)/PSV.
Measured: Change from baseline RI immediately
Pulsatile Index (PI)
Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography. PI is defined with the formula PI = (PSV - EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle.
Measured: Change from baseline PI immediately
End Diastolic Velocity (EDV)
EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak.
Measured: Change from baseline EDV immediately
Secondary outcomes (2)
Pain Pressure Thresholds (PPT)
Pressure pain threshold (kPa) is a quantitative sensory test, used to measure deep muscular tissue sensitivity to mechanical pressure stimuli. The test determines the amount of pressure over the infraspinatus in which a steadily increasing non-painful pressure stimulus turns into a painful pressure sensation.
Measured: Change from baseline PPT immediately
Shoulder Range of Motion
shoulder range of motion of internal and external rotation is the number of degrees of motion measured using standard goniometry.
Measured: Change from baseline shoulder range of motion immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start22 Oct 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dry NeedlingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Pre-test Post-Test Design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jace Brown, Texas Woman's University
- Investigators
- Jace A Brown, DPT, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596240
- Sponsor's protocol ID
- IRB-FY2022-438
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
PubMed 21711512Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.
PubMed 21943613Ge HY, Fernandez-de-Las-Penas C, Yue SW. Myofascial trigger points: spontaneous electrical activity and its consequences for pain induction and propagation. Chin Med. 2011 Mar 25;6:13. doi: 10.1186/1749-8546-6-13.
PubMed 21439050Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
PubMed 25724849Sandberg M, Lundeberg T, Lindberg LG, Gerdle B. Effects of acupuncture on skin and muscle blood flow in healthy subjects. Eur J Appl Physiol. 2003 Sep;90(1-2):114-9. doi: 10.1007/s00421-003-0825-3. Epub 2003 Jun 24.
PubMed 12827364Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
PubMed 8043247Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
PubMed 22506152Nascimento JDSD, Alburquerque-Sendin F, Vigolvino LP, Oliveira WF, Sousa CO. Absolute and Relative Reliability of Pressure Pain Threshold Assessments in the Shoulder Muscles of Participants With and Without Unilateral Subacromial Impingement Syndrome. J Manipulative Physiol Ther. 2020 Jan;43(1):57-67. doi: 10.1016/j.jmpt.2019.04.002. Epub 2020 Feb 13.
PubMed 32061418
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dry Needling on Muscle Blood Flow of the Infraspinatus in Individuals with Shoulder Pain - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05596240
- Acronym / sponsor ID
- IRB-FY2022-438
- Conditions
- Dry Needling, Shoulder Pain
- Keywords
- dry needling, shoulder pain, pain pressure threshold
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 27 Oct 2022 (actual)
- 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.
Shoulder pain is one of the most common reasons people consult with their primary health care provider, and 40-50% of these patients with shoulder pain continued to complain of persistent symptoms after 6 to 12 months. It has been suggested that the presence of myofascial trigger points (MTrPs) may contribute to the chronicity of shoulder symptoms. An MTrP is a hyperirritable taut band of tissue within a muscle that produces pain when stimulated MTrPs are common in patients with shoulder disorders and occur most often in the infraspinatus muscle of a painful shoulder MTrPs were associated with an acidic biochemical environment with elevated levels of inflammatory mediators, neuropeptides, and proinflammatory cytokines such as bradykinin and calcitonin g-related peptide. It was hypothesized that metabolic demands on muscle and capillary constrictions may contribute to the development of MTrPs. To date, only a few studies have examined the vascular environment of MTrPs and surrounding areas before and after dry needling. No studies have yet examined whether dry needling would change blood flow in patients with shoulder pathology. Therefore, the purpose of this pilot study is to examine the effect of dry needling on blood flow of the infraspinatus muscle using color Doppler imaging in individuals with shoulder pain. The secondary purpose is to examine the effect of DN on shoulder motion and sensitivity to pressure in individuals with shoulder pain.
Detailed description
RESEARCH DESIGN This pilot study will be a single-blinded randomized comparison trial with two groups: (1) the group that will receive real DN, and (2) a placebo group that will receive sham DN. The research design will be a prospective two-way (2 x 2) mixed design to examine the effects of DN on blood flow (i.e., peak systolic velocity, end diastolic velocity, resistive index, pulsatile index) of the infraspinatus, shoulder range of motionss of internal rotation and external rotation, and PPTs of the infraspinatus. The two independent variables are: (1) group with two levels (DN and sham DN groups), and (2) time with two levels (baseline and immediately after the intervention) for the peak systolic velocity, end diastolic velocity, resistive index, pulsatile index of the infraspinatus, shoulder internal rotation, shoulder external rotation, and PPTS of the infraspinatus.
INSTRUMENTATION A color-Doppler ultrasonographic scanner and a curvilinear transducer (Sonosite Edge; Sonosite, Inc., Bothell, WA) will be used to measure blood flow of the infraspinatus muscle. The curvilinear probe (5-2MHz) has ability to capture images up to 30 cm in depth. A standard goniometer with 1° increments will be used to measure shoulder ROMs. Standard goniometric measurements have shown good-to-excellent reliability for shoulder internal and external ROMs.23 A hand-held computerized pressure algometer (Medoc ltd., Ramat Yishai, Israel) will be used to measure the PPT over the infraspinatus muscle. The algometer consists of a 1 cm2 round-tip that will be pressed perpendicular to the skin of the infraspinatus muscle at a rate of 40kPa/s until the first perception of pain or discomfort detected by the participant. The participant will be able to stop the test with a press of a button upon feeling the first sensation of pain or discomfort. This device has shown to have high test-retest reliability (intraclass correlation coefficients = 0.70-0.94) in the shoulder and neck muscles.
PROCEDURE At the beginning of the visit, all participants will be asked for demographic information and their pain-related characteristics, including location, duration, intensity at onset, and intensity currently, at best, and at worst in the previous 24-hours using the NPRS. After the subjective information is gathered, an investigator will assess for the presence of MTrP based on palpation. The participant will be placed in the prone position with arms resting at their side. The examiner will palpate the infraspinatus muscle belly for the presence of a taut band, a hypersensitive spot, and reproduction of the participants symptoms.11 Al-Shenqiti and Oldham25 demonstrated high reliability (k=0.86) with palpation for the presence or absence of the taut band, spot tenderness, and/or referred pain sensation.
Once the participant is determined eligible, they will be asked to complete the Quick Disability of Arm Shoulder Hand (QuickDASH) questionnaire to determine their self-reported disability and function (Appendix C).26 Next, the three outcome measures will be collected, including blood flow parameters, shoulder ROMs, and PPTs. If the participant has bilateral shoulder pain, the most painful shoulder will be tested. If both shoulders are equally painful, a coin-flip will be used to determine the side on which testing will be performed. The outcome measurements will be administered in an order of shoulder ROMs, followed by PPT and blood flow parameters before the DN intervention. Following the intervention, the outcome measurements will be collected in a reverse order of blood flow parameters, PPT, and shoulder ROM to minimize the position changes and to capture immediate changes of blood flow. These outcomes will be assessed by an investigator blinded to the intervention assignment.
SHOULDER RANGE OF MOTION ROM testing will be performed while the participant is lying supine with the shoulder at 90° abduction and 10° of horizontal abduction and elbow at 90°flexion. The examiner will be responsible for all the measurements. The center of rotation of the goniometer will be placed over the olecranon while one arm of the goniometer will be positioned along the length of the ulna, aligned with the ulnar styloid process. The other arm will be positioned perpendicular to the ground. For both measurement of internal and external rotation, scapular compensation will be monitored by using the thumb on the coracoid process and fingers along the spine of the scapula. Each measurement will be repeated three times with the average measurements used for data analysis.
PRESSURE PAIN THRESHOLD MEASUREMENT During the PPT testing, the participant will be placed in the prone position with upper extremities relaxed at their sides. PPT of the infraspinatus muscle will be tested in the muscle belly 1.5 inches below the midpoint of the spine of scapula. The participants will be given a stop button and will be instructed to stop the test as soon as the pressure becomes uncomfortable or painful, and not to allow a painful or uncomfortable sensation to continue. The participants will be familiarized with the algometer, which will consist of a single trial on the non-painful side to ensure that the participant understands the process. A total of three trials will be performed and the average of three trials will be used for data analysis. The PPT of the infraspinatus muscle has been shown to have good-to-excellent intraday, interday, intrarater, and interrater reliability.27,28
ULTRASOUND IMAGING Each participant will remain in the same position for ultrasound imaging. The ultrasound transducer will be placed perpendicular to the infraspinous fossa to visualize arterioles or arteries in the vicinity of the MTrPs and to quantify the velocity of flow at the MTrPs of the infraspinatus. The location of the transducer will be outlined after initial placement to ensure consistent placement of the transducer between trials as well as before and after DN. The spectral Doppler waveforms will be analyzed to trace the velocities throughout the cardiac cycle. The peak systolic (PSV), end diastolic velocity (EDV), resistive index (RI), and pulsatile index (PI) will be calculated using software available on the device. On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window, whereas the EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV and the PI with the formula PI = (PSV EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle. A reliability study is currently underway to establish the test-retest reliability of this ultrasound testing protocol (TWU IRB # IRB-FY2022-349).
INTERVENTION Following the baseline testing, the participants will be randomly assigned to either the real DN group or sham DN group. A large opaque envelope containing 40 cards, 20 cards marked "DN" and 20 marked "sham DN" will be used for random assignment. Each participant will be randomly assigned based on the card drawn from the envelope. The group assignment will be performed by the treating physical therapist. If a participant withdraws from the study, a card for the group to which they are assigned will be returned to the envelope.
For the real DN group, the technique described by Hong14 will be used to needle the two to four MTrPs in the infraspinatus muscle based on the results of the examiner's palpation. A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the MTrP of the infraspinatus muscles. Once the needle has been inserted, the needle will be pistoned in an up-and-down motion within the infraspinatus muscle at approximately 1Hz for 10 seconds with the aim of eliciting local twitch responses.
Streitberger Placebo-needles (Asia-med, Las Vegas, NV) will be used to perform the intervention for participants in the sham DN group. These needles have been reported to be indistinguishable from real needles. The device consists of a plastic tube with a blunted tip needle that allows for the sensation of a prick without penetrating the skin. The sham needle produces a sensation, which causes the participant to feel as if the needle enters the skin, while maintaining similar patient-therapist contact time and total intervention time.29
REASSESSMENT Immediately following the intervention, the three outcomes will be collected from all participants in the following order to minimize position changes: blood flow parameters, PPT, and shoulder ROMs. Additionally, any adverse events, such as bruising, nausea, dizziness, or post-needling soreness following the dry needling procedures will be assessed immediately. If bleeding occurs, the participant will be informed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pre-test Post-Test Design
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Other: Dry NeedlingIndividuals with shoulder pain will receive dry needling to the two to four most tender points in the infraspinatus based on examiner palpation |
| Sham Dry Needling | Placebo comparator | Other: Sham Dry NeedlingIndividuals with shoulder pain will receive sham dry needling to two points in the muscle belly of the infraspinatus near the insertion and below the midpoint of the spine of the scapula |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-65 with unilateral nonspecific shoulder pain based on participants' self-reported pain level of greater than or equal to 2/10 on the Numeric Pain Rating Scale (NPRS) in last 24 hours
- non-traumatic origin of pain
- presence of at least one MTrP with referral pain pattern in the infraspinatus muscle determined through palpation.
Key exclusion criteria (13 listed)
- systemic joint disease (e.g. rheumatoid arthritis)
- evidence of red flags (e.g. signs of current fracture or history of fracture to scapula, glenoid or proximal humerus, infection, tumor, incontinence, or paresthesias)
- cancer
- neurological disorders
- neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingA sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the MTrP of the infraspinatus muscles. Once the needle has been inserted, the technique described by Hong (1994) will be used. The needle will be pistoned in an up and down motion within the infraspinatus muscle at approximately 1Hz for 10 seconds with the aim of eliciting local twitch responses. | Other | Dry Needling |
| Sham Dry NeedlingStreitberger Placebo-needles (Asia-med, Las Vegas, NV) will be used to perform the intervention for participants in the sham DN group. These needles have been reported to be indistinguishable from real needles. The device consists of a plastic tube with a blunted tip needle that allows for the sensation of a prick without penetrating the skin. The sham needle produces a sensation, which causes the participant to feel as if the needle enters the skin, while maintaining similar patient-therapist contact time and total intervention time. | Other | Sham Dry Needling |
Primary outcome
Peak Systolic Velocity
Time frame: Change from baseline PSV immediately
On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV.
Resistive Index (RI)
Time frame: Change from baseline RI immediately
Resistive Index is used to assess the resistance in a pulsatile vascular system.The RI is defined by the the formula RI = (PSV - EDV)/PSV.
Pulsatile Index (PI)
Time frame: Change from baseline PI immediately
Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography. PI is defined with the formula PI = (PSV - EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle.
End Diastolic Velocity (EDV)
Time frame: Change from baseline EDV immediately
EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak.
2 secondary outcomes
Pain Pressure Thresholds (PPT)
Time frame: Change from baseline PPT immediately
Shoulder Range of Motion
Time frame: Change from baseline shoulder range of motion immediately
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 21711512Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
- Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Background: PubMed 21943613Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.
- Background: PubMed 21439050Ge HY, Fernandez-de-Las-Penas C, Yue SW. Myofascial trigger points: spontaneous electrical activity and its consequences for pain induction and propagation. Chin Med. 2011 Mar 25;6:13. doi: 10.1186/1749-8546-6-13.
- Background: PubMed 25724849Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
- Background: PubMed 12827364Sandberg M, Lundeberg T, Lindberg LG, Gerdle B. Effects of acupuncture on skin and muscle blood flow in healthy subjects. Eur J Appl Physiol. 2003 Sep;90(1-2):114-9. doi: 10.1007/s00421-003-0825-3. Epub 2003 Jun 24.
- Background: PubMed 8043247Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
- Background: PubMed 22506152Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
- Background: PubMed 32061418Nascimento JDSD, Alburquerque-Sendin F, Vigolvino LP, Oliveira WF, Sousa CO. Absolute and Relative Reliability of Pressure Pain Threshold Assessments in the Shoulder Muscles of Participants With and Without Unilateral Subacromial Impingement Syndrome. J Manipulative Physiol Ther. 2020 Jan;43(1):57-67. doi: 10.1016/j.jmpt.2019.04.002. Epub 2020 Feb 13.
- Individual participant dataSharing planned: Yes
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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.
Jace A Brown, DPT principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Dry Needling and Shoulder Pain, run by Texas Woman's University 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 3 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Peak Systolic Velocity (time frame: Change from baseline PSV immediately). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596240, which also lists 9 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 19 Nov 2024.