NCT04295200

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

February 22, 2020

Last Update Submit

August 30, 2021

Conditions

Keywords

lumbar multifididry needlingelectromyographykinematic

Outcome Measures

Primary Outcomes (2)

  • Muscle activity changes

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

    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

  • Kinematic changes

    Measurement of lumbopelvic angles during range of motion activities

    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

Study Arms (1)

Dry needling with electrical stimulation

EXPERIMENTAL

Use 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.

Other: Dry needling with electrical stimulation

Interventions

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.

Dry needling with electrical stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Health Science Center

Shreveport, Louisiana, 71103, United States

Location

Related Publications (19)

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

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

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

    BACKGROUND
  • 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.

    PMID: 25801100BACKGROUND
  • 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.

    PMID: 28167189BACKGROUND
  • 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.

    PMID: 27685009BACKGROUND
  • 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.

    PMID: 29864043BACKGROUND
  • 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.

    PMID: 26075156BACKGROUND
  • 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.

    PMID: 28690077BACKGROUND
  • 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.

    PMID: 24261928BACKGROUND
  • 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.

    PMID: 23593553BACKGROUND
  • 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.

    PMID: 27623385BACKGROUND
  • 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.

    PMID: 26406203BACKGROUND
  • 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.

    PMID: 21439050BACKGROUND
  • 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.

    PMID: 20667633BACKGROUND
  • Ge HY, Monterde S, Graven-Nielsen T, Arendt-Nielsen L. Latent myofascial trigger points are associated with an increased intramuscular electromyographic activity during synergistic muscle activation. J Pain. 2014 Feb;15(2):181-7. doi: 10.1016/j.jpain.2013.10.009. Epub 2013 Nov 2.

    PMID: 24189107BACKGROUND
  • Ibarra JM, Ge HY, Wang C, Martinez Vizcaino V, Graven-Nielsen T, Arendt-Nielsen L. Latent myofascial trigger points are associated with an increased antagonistic muscle activity during agonist muscle contraction. J Pain. 2011 Dec;12(12):1282-8. doi: 10.1016/j.jpain.2011.09.005. Epub 2011 Nov 11.

    PMID: 22078789BACKGROUND
  • Baima J, Isaac Z. Clean versus sterile technique for common joint injections: a review from the physiatry perspective. Curr Rev Musculoskelet Med. 2008 Jun;1(2):88-91. doi: 10.1007/s12178-007-9011-2.

    PMID: 19468878BACKGROUND
  • Administration FaD. Code of Federal Regulations Title 21. 2018; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5580. Accessed March 24, 2019.

    BACKGROUND

MeSH Terms

Interventions

Dry NeedlingElectric Stimulation

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPhysical StimulationInvestigative Techniques

Study Officials

  • April J Brown, DPT

    LSU Health Science Center Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single group pre-test/post-test study design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy, Clinical Instructor

Study Record Dates

First Submitted

February 22, 2020

First Posted

March 4, 2020

Study Start

December 16, 2019

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations