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HealthyNCT04295200

Muscle Activity and Kinematic Changes With Dry Needling

A study testing Dry needling with electrical stimulation in people with Healthy, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study assesses the effects of dry needling with electrical stimulation to the low back on muscle activity and changes in movement. The investigators hypothesize that dry needling and electrical stimulation will elicit changes in muscle activity as well as changes in movement. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Dry needling with electrical stimulation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Dec 2019to 16 Jun 2021
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

  • English speaking individuals between the ages of 18 and 60 years old
  • without current complaint of low back pain
  • no history of low back or lower extremity surgery

Who cannot join

  • individuals with current complaint of low back pain,
  • lumbar radicular symptoms
  • history of low back surgery or lower extremity surgery
  • pregnancy or planning to become pregnant,
  • currently taking immunosuppressant or anticoagulation use with INR not within therapeutic range
  • needle phobia
  • osteoporosis will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LSU Health Science Center

    Shreveport, Louisiana, 71103

Other trials in United States

About this study

Official title: Changes in Muscle Activity, Squat, and Gait Kinematics After Dry Needling Treatment of the Low Back: A Pilot Study

This study assesses the effects of dry needling with electrical stimulation to the low back on muscle activity and changes in movement. The investigators hypothesize that dry needling and electrical stimulation will elicit changes in muscle activity as well as changes in movement.

Read the detailed description

This study will utilize a Vicon motion capture system in conjunction with a Noraxon wireless surface electromyography system to analyze movements and muscle activity of each participant pre and post needling.

Conditions
Healthy
Being tested
Dry needling with electrical stimulation
Keywords
lumbar multifidi, dry needling, electromyography, kinematic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needling with electrical stimulationOther

    Paravertebral dry needling to L3, 4, 5 multifidi. Electrical stimulation will be applied through the needles for up to 10 minutes total or to the participant's tolerance.

Study groups in NCT04295200
Study groupRoleWhat they receive
Dry needling with electrical stimulationExperimentalUse of dry needles (this is the generic name for sterile, solid filament needles) are inserted into the lumbar multifidi. Intramuscular electrical stimulation will then be applied by attaching a six-lead electrical stimulation unit to the needles. Electrical stimulation will be applied through the needles at the participant's desired frequency (between 4-6 Hz) and for up to 10 minutes total.
Receives: Other: Dry needling with electrical stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle activity changes

    activity measured and quantified from the amplitude (mV) of the surface EMG electrodes

    Measured: pre/ post dry needling treatment. Participants' EMG will be recorded over a series of movements of the lumbar spine, will immediately be dry needled with electrical stimulation for up to 10 minutes, then will be immediately reassessed. Total time 2 hours

  2. Kinematic changes

    Measurement of lumbopelvic angles during range of motion activities

    Measured: Participants kinematics will be recorded over a series of movements of the lumbar spine, will immediately be dry needled with electrical stimulation for up to 10 minutes, then will be immediately reassessed. Total time 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study start16 Dec 2019
  3. Primary completion16 Jun 2021
  4. Study completion16 Jun 2021

Resources

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
Not applicable
Intervention model
Single group
Model description
single group pre-test/post-test study design
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04295200
Sponsor's protocol ID
IRB00001301
Status last verified
Aug 2021
First submitted
22 Feb 2020
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Association APT. Dry needling in clinical practice:an educational resource paper. Alexandria, VA: American Physical Therapy Association; 2013.

  • Therapy FoSBoP. Dry Neelding Resource Paper (Intramuscular Manual Therapy). 4th ed. Alexandria, VA: Federation of State Boards of Physical Therapy; 2013.

  • Caldwell J. Attorney General Opinion 14-0216. In: Justice2015.

  • Koppenhaver SL, Walker MJ, Su J, McGowen JM, Umlauf L, Harris KD, Ross MD. Changes in lumbar multifidus muscle function and nociceptive sensitivity in low back pain patient responders versus non-responders after dry needling treatment. Man Ther. 2015 Dec;20(6):769-76. doi: 10.1016/j.math.2015.03.003. Epub 2015 Mar 13.

    PubMed 25801100

  • Abbaszadeh-Amirdehi M, Ansari NN, Naghdi S, Olyaei G, Nourbakhsh MR. Neurophysiological and clinical effects of dry needling in patients with upper trapezius myofascial trigger points. J Bodyw Mov Ther. 2017 Jan;21(1):48-52. doi: 10.1016/j.jbmt.2016.04.014. Epub 2016 Apr 14.

    PubMed 28167189

  • Haser C, Stoggl T, Kriner M, Mikoleit J, Wolfahrt B, Scherr J, Halle M, Pfab F. Effect of Dry Needling on Thigh Muscle Strength and Hip Flexion in Elite Soccer Players. Med Sci Sports Exerc. 2017 Feb;49(2):378-383. doi: 10.1249/MSS.0000000000001111.

    PubMed 27685009

  • Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.

    PubMed 29864043

  • Unverzagt C, Berglund K, Thomas JJ. DRY NEEDLING FOR MYOFASCIAL TRIGGER POINT PAIN: A CLINICAL COMMENTARY. Int J Sports Phys Ther. 2015 Jun;10(3):402-18.

    PubMed 26075156

  • Liu L, Huang QM, Liu QG, Thitham N, Li LH, Ma YT, Zhao JM. Evidence for Dry Needling in the Management of Myofascial Trigger Points Associated With Low Back Pain: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):144-152.e2. doi: 10.1016/j.apmr.2017.06.008. Epub 2017 Jul 8.

    PubMed 28690077

  • Jayaseelan DJ, Moats N, Ricardo CR. Rehabilitation of proximal hamstring tendinopathy utilizing eccentric training, lumbopelvic stabilization, and trigger point dry needling: 2 case reports. J Orthop Sports Phys Ther. 2014 Mar;44(3):198-205. doi: 10.2519/jospt.2014.4905. Epub 2013 Nov 21.

    PubMed 24261928

  • Rainey CE. The use of trigger point dry needling and intramuscular electrical stimulation for a subject with chronic low back pain: a case report. Int J Sports Phys Ther. 2013 Apr;8(2):145-61.

    PubMed 23593553

  • Koppenhaver SL, Walker MJ, Rettig C, Davis J, Nelson C, Su J, Fernandez-de-Las-Penas C, Hebert JJ. The association between dry needling-induced twitch response and change in pain and muscle function in patients with low back pain: a quasi-experimental study. Physiotherapy. 2017 Jun;103(2):131-137. doi: 10.1016/j.physio.2016.05.002. Epub 2016 May 20.

    PubMed 27623385

  • Dar G, Hicks GE. The immediate effect of dry needling on multifidus muscles' function in healthy individuals. J Back Musculoskelet Rehabil. 2016 Apr 27;29(2):273-278. doi: 10.3233/BMR-150624.

    PubMed 26406203

  • Ge 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 21439050

  • Lucas KR, Rich PA, Polus BI. Muscle activation patterns in the scapular positioning muscles during loaded scapular plane elevation: the effects of Latent Myofascial Trigger Points. Clin Biomech (Bristol). 2010 Oct;25(8):765-70. doi: 10.1016/j.clinbiomech.2010.05.006. Epub 2010 Jul 27.

    PubMed 20667633

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling with electrical stimulation in people with Healthy, run by Louisiana State University Health Sciences Center Shreveport 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 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 31 Aug 2021. 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?

Muscle activity changes (time frame: pre/ post dry needling treatment. Participants' EMG will be recorded over a series of movements of the lumbar spine, will immediately be dry needled with electrical stimulation for up to 10 minutes, then will be immediately reassessed. Total time 2 hours). 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 NCT04295200, which also lists 19 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 31 Aug 2021.

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