Trigger Point Pain, MyofascialNCT03689283
The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Trigger Points
A study testing Dry Needling in people with Trigger Point Pain, Myofascial, run by Regis University at 1 site in United States.
Trial summary
This study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 21 Jan 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- Able to read and speak sufficient English to complete consent form
- Symmetrical gait pattern demonstrated through observation
- Presence of latent trigger point in gastrocnemius muscle
Who cannot join
- Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius
- Any prior acupuncture or dry needling within the past month
- History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)
- Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
- Restrictions in plantar flexion range of motion which would inhibit performing a heel raise
- No specific calf injury in the past 6 months
- Participants known or thought to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Latent Trigger Points
This study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength. The study has the potential to demonstrate that dry needling may have immediate effects on mechanical properties of muscle and may thus guide future treatment for individuals with changes in muscle tissue secondary to pain and/or injury.
Read the detailed description
Participants will complete the following tests: muscle stiffness testing in both a relaxed and contracted position, GAITRite for spatial and temporal gait characteristics, the Ankle Lunge Test (ALT) to assess range of motion, and calf strength using a dynamometer. Subjects will then receive treatment according to which group they are randomized. Muscle stiffness, gait, motion and strength will be reassessed immediately following treatment at the first session. Four to10 days later, participants will complete the same tests and measures prior to treatment being administered a second time. Another 4-10 days after the second session, participants will complete the tests and measures one final time.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Dry Needling, Sham Dry Needlling
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle
Sham Dry NeedllingOther
Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | Individuals in the DN arm will receive two treatment sessions of DN to latent trigger points of the gastrocnemius muscle. Receives: Other: Dry Needling |
| Control Group | Sham comparator | Individuals in the control group will receive two treatment sessions of sham dry needling. Receives: Other: Sham Dry Needlling |
What is being measured
The primary outcome is the main question the study is designed to answer.
MyotonPRO
Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device
Measured: 2 years
Secondary outcomes (3)
Knee to wall
Group by time differences will be assessed for talocrural motion (knee to wall)
Measured: 2 years
GAITRite
Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat)
Measured: 2 years
Handheld dynamometer
Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start25 Oct 2018
- Primary completion31 Dec 2019
- Study completion21 Jan 2020
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 Trigger Point Pain, MyofascialStudies 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
- Factorial
- Model description
- Prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Albin, Regis University
- Investigators
- Stephanie Albin, PhD, Principal investigator, Regis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689283
- Sponsor's protocol ID
- RegisU
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. doi: 10.7863/jum.2012.31.8.1209.
PubMed 22837285Bandy WD, Nelson R, Beamer L. COMPARISON OF DRY NEEDLING VS. SHAM ON THE PERFORMANCE OF VERTICAL JUMP. Int J Sports Phys Ther. 2017 Oct;12(5):747-751.
PubMed 29181252Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4.
PubMed 22222143Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.
PubMed 15834340
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Latent Trigger Points
- ClinicalTrials.gov ID
- NCT03689283
- Acronym / sponsor ID
- RegisU
- Conditions
- Trigger Point Pain, Myofascial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Regis UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 28 Sep 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.
This study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength. The study has the potential to demonstrate that dry needling may have immediate effects on mechanical properties of muscle and may thus guide future treatment for individuals with changes in muscle tissue secondary to pain and/or injury.
Detailed description
Participants will complete the following tests: muscle stiffness testing in both a relaxed and contracted position, GAITRite for spatial and temporal gait characteristics, the Ankle Lunge Test (ALT) to assess range of motion, and calf strength using a dynamometer. Subjects will then receive treatment according to which group they are randomized. Muscle stiffness, gait, motion and strength will be reassessed immediately following treatment at the first session. Four to10 days later, participants will complete the same tests and measures prior to treatment being administered a second time. Another 4-10 days after the second session, participants will complete the tests and measures one final time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Other: Dry NeedlingIndividuals in the DN arm will receive two treatment sessions of DN to latent trigger points of the gastrocnemius muscle. |
| Control Group | Sham comparator | Other: Sham Dry NeedllingIndividuals in the control group will receive two treatment sessions of sham dry needling. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-50 years
- Able to read and speak sufficient English to complete consent form
- Symmetrical gait pattern demonstrated through observation
- Presence of latent trigger point in gastrocnemius muscle
Key exclusion criteria (7 listed)
- Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius
- Any prior acupuncture or dry needling within the past month
- History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)
- Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
- Restrictions in plantar flexion range of motion which would inhibit performing a heel raise
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 NeedlingIndividuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle | Other | Dry Needling Group |
| Sham Dry NeedllingIndividuals randomized to the Control group will receive sham needling to the gastrocnemius muscle | Other | Control Group |
Primary outcome
MyotonPRO
Time frame: 2 years
Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device
3 secondary outcomes
Knee to wall
Time frame: 2 years
GAITRite
Time frame: 2 years
Handheld dynamometer
Time frame: 2 years
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 22 Jan 2020.
- Background: PubMed 22837285Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. doi: 10.7863/jum.2012.31.8.1209.
- Background: PubMed 29181252Bandy WD, Nelson R, Beamer L. COMPARISON OF DRY NEEDLING VS. SHAM ON THE PERFORMANCE OF VERTICAL JUMP. Int J Sports Phys Ther. 2017 Oct;12(5):747-751.
- Background: PubMed 22222143Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4.
- Background: PubMed 15834340Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.
- 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.
Stephanie Albin, PhD principal investigator
Regis 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 Trigger Point Pain, Myofascial, run by Regis 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 4 inclusion and 7 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 22 Jan 2020. 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?
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?
MyotonPRO (time frame: 2 years). 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 NCT03689283, 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 22 Jan 2020.