Myofascial PainNCT03638388
Dry Needling vs Dry Needling With ES in Patients With Neck/Shoulder Pain
A study testing Dry needling (DN) and Dry needling with intramuscular electrical stimulation (DNES) in people with Myofascial Pain and Neck Pain, run by Kindyle Brennan at 1 site in United States.
Trial summary
First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain, Neck Pain, Shoulder Pain
- What is being tested?
- Dry needling (DN) and Dry needling with intramuscular electrical stimulation (DNES)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 1 Feb 2019
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking
Who cannot join
- current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mary Hardin-Baylor
Belton, Texas, 76513
About this study
Official title: Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation
First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention.
Research Questions:
- Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)?
- Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?
- Conditions
- Myofascial Pain, Neck Pain, Shoulder Pain
- Being tested
- Dry needling (DN), Dry needling with intramuscular electrical stimulation (DNES)
- Medical subject headings
- Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling (DN)Procedure or surgery
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.
Dry needling with intramuscular electrical stimulation (DNES)Procedure or surgery
One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling (DN) | Active comparator | Subjects will receive dry needling treatment, once a week, for 6 weeks.
Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12). Receives: Procedure: Dry needling (DN) |
| Dry Needling with Intramuscular electrical stimulation (DNES) | Active comparator | Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks.
Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12). Receives: Procedure: Dry needling with intramuscular electrical stimulation (DNES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of improvement in numerical pain rating scale between groups
Between group difference in within group pain changes
Measured: 6 weeks
Rate of improvement in Neck Disability Index between groups
Between group difference of within group disability changes
Measured: 6 weeks
Secondary outcomes (2)
Maintenance of pain improvement in both groups
Difference between pain scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
Measured: week 6 compared to week 12 data
Maintenance of disability improvement in both groups
Difference between neck disability scores in both groups between the 6th week of weekly treatment and those 6 weeks after cessation of treatment.
Measured: week 6 compared to week 12 data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start16 Aug 2018
- Primary completion1 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myofascial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental There will be two groups in this study, DN alone and DN/IES. Each group will have approximately 22 subjects, resulting in approximately 44 subjects total. Subjects will be randomized into one of the two groups via block randomization method based on order of entry into the study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kindyle Brennan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kindyle Brennan, University of Mary Hardin-Baylor
- Investigators
- Kindyle L. Brennan, PHD,PT, Principal investigator, University of Mary Hardin-Baylor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638388
- Sponsor's protocol ID
- DNvDN-ES
- Status last verified
- Mar 2019
- First submitted
- 16 Aug 2018
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
PubMed 28025371Pilgrim J, Engelke Z. Patient Education: Teaching the patient about myofascial pain syndrome. CINAHL Nursing Guide. December 8, 2017;Available from: Nursing Reference Center Plus, Ipswich, MA. Accessed April 13, 2018.
Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
PubMed 25576642Rock JM, Rainey CE. Treatment of nonspecific thoracic spine pain with trigger point dry needling and intramuscular electrical stimulation: a case series. Int J Sports Phys Ther. 2014 Oct;9(5):699-711.
PubMed 25328832
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate and Maintenance of Improvement in Myofascial Pain: Dry Needling Alone vs Dry Needling With Intramuscular Electrical Stimulation
- ClinicalTrials.gov ID
- NCT03638388
- Acronym / sponsor ID
- DNvDN-ES
- Conditions
- Myofascial Pain, Neck Pain, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kindyle BrennanUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 20 Aug 2018 (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.
First, we aim to determine if there is a difference in the rate of improvement, as measured by the Neck Disability Index (NDI) and Numerical Pain Rating Scale (NPRS), across a 6 week treatment period between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES) in subjects with upper trapezius active trigger points (aTrPs). Secondly, we want to determine if improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) alone or dry needling with intramuscular electrical stimulation (DN/IES) are maintained 6 weeks post treatment without further intervention.
Research Questions:
- Is there a difference in the rate of improvement in NDI and NPRS across a 6 week treatment period in subjects with upper trapezius active trigger points (aTrPs) between those treated with DN only and those treated with DN and intramuscular electrical stimulation (IES)?
- Are improvements in clinical outcomes (NDI and NPRS) of patients with upper trapezius active trigger points (aTrPs) treated with dry needling (DN) maintained 6 weeks post treatment without further intervention? Tertiary exploration: If improvement is maintained, is there a difference in outcome maintenance between groups? Did improvement increase between 6 and 12 weeks?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental There will be two groups in this study, DN alone and DN/IES. Each group will have approximately 22 subjects, resulting in approximately 44 subjects total. Subjects will be randomized into one of the two groups via block randomization method based on order of entry into the study.
| Arm | Type | Receives |
|---|---|---|
| Dry Needling (DN) | Active comparator | Procedure: Dry needling (DN)Subjects will receive dry needling treatment, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12). |
| Dry Needling with Intramuscular electrical stimulation (DNES) | Active comparator | Procedure: Dry needling with intramuscular electrical stimulation (DNES)Subjects will receive dry needling treatment with electrical stimulation, once a week, for 6 weeks. Outcomes will be measured at baseline (week 0), 3 weeks after initiation of study (week 3), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-59 years old have an active email account have at least one palpable active trigger point (TrP) (located in one or both upper trapezius) English speaking
Key exclusion criteria (1 listed)
- current or previous history of cancer active infection neurologic deficit cognitive deficit pregnancy connective tissue disease and/or autoimmune disorder smoke tobacco received previous DN treatments within 6 weeks of the study, experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
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 needling (DN)One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded. | Procedure or surgery | Dry Needling (DN) |
| Dry needling with intramuscular electrical stimulation (DNES)One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded. | Procedure or surgery | Dry Needling with Intramuscular electrical stimulation (DNES) |
Primary outcome
Rate of improvement in numerical pain rating scale between groups
Time frame: 6 weeks
Between group difference in within group pain changes
Rate of improvement in Neck Disability Index between groups
Time frame: 6 weeks
Between group difference of within group disability changes
2 secondary outcomes
Maintenance of pain improvement in both groups
Time frame: week 6 compared to week 12 data
Maintenance of disability improvement in both groups
Time frame: week 6 compared to week 12 data
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 25 Mar 2019.
- Background: PubMed 28025371Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
- BackgroundPilgrim J, Engelke Z. Patient Education: Teaching the patient about myofascial pain syndrome. CINAHL Nursing Guide. December 8, 2017;Available from: Nursing Reference Center Plus, Ipswich, MA. Accessed April 13, 2018.
- Background: PubMed 25576642Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
- Background: PubMed 25328832Rock JM, Rainey CE. Treatment of nonspecific thoracic spine pain with trigger point dry needling and intramuscular electrical stimulation: a case series. Int J Sports Phys Ther. 2014 Oct;9(5):699-711.
- Individual participant dataSharing planned: No
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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.
Kindyle L. Brennan, PHD,PT principal investigator
University of Mary Hardin-Baylor
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 (DN) and Dry needling with intramuscular electrical stimulation (DNES) in people with Myofascial Pain and Neck Pain, run by Kindyle Brennan 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 1 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 25 Mar 2019. 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.
What does the primary outcome measure?
Rate of improvement in numerical pain rating scale between groups (time frame: 6 weeks). The study lists 2 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 NCT03638388, which also lists 4 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 25 Mar 2019.