AzTrials
AzTrials

Sub-acute and Chronic Low Back PainNCT03539588

Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation

A study testing trigger point dry needling and Electrical Stimulation in people with Sub-acute and Chronic Low Back Pain, run by William Beaumont Army Medical Center 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
Search all trials

Trial summary

trigger point dry needling with intramuscular electrical stimulation vs trigger point dry needling Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Sub-acute and Chronic Low Back Pain
What is being tested?
trigger point dry needling and Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
12 Apr 2017to 13 Nov 2017
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently experience low back pain for greater than 4 weeks (Low back pain defined as pain below the T12th vertebrae with or without radiation) Military or DOD Beneficiary (any branch; 18-65 years of age)

Who cannot join

  • Structural Deformity (ankylosing Spondylitis, Scoliosis)
  • Has any other Orthopedic condition that may keep subject from performing Low - Back Exercises
  • Tumors
  • Spinal infection or local infection
  • Pregnancy-All female subjects will be given either a blood serum or urine pregnancy test.
  • Spinal cord compression or Cauda Equina Syndrome
Show all 12Show fewer
  • Subject with the inability to keep appointments
  • Has History of prior surgery
  • Has received Dry Needling or Acupuncture in the last 6 months
  • History of bleeding disorders
  • High anti-coagulant use
  • History of immune suppression

Trial locations and contacts

1 site in 1 country.

United States1 site

  • William BAMC

    El Paso, Texas, 79920

Other trials in United States

About this study

Official title: Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation for the Treatment of Sub-acute and Chronic Low Back Pain in a Military Population: A Randomized Crossover Design

trigger point dry needling with intramuscular electrical stimulation vs trigger point dry needling

Read the detailed description

The purpose of this study is to evaluate if trigger point dry needling with intramuscular electrical stimulation is more effective in decreasing pain and disability in individuals with sub-acute and chronic low back pain (LBP) than with trigger point dry needling alone. The investigators are using a within subjects randomized crossover study that will recruit 30 active duty military personnel or beneficiaries from William Beaumont Army Medical Center and all associated clinics. The investigators hypothesize that individuals with LBP will exhibit larger improvements in pain and disability when receiving trigger point dry needling with intramuscular electrical stimulation than when receiving trigger point dry needling alone.

Being tested
trigger point dry needling, Electrical Stimulation
Keywords
dry needling, electrical stimulation, E-Stim, LBP, low back pain, trigger point, chronic, subacute
Medical subject headings
Low Back Pain, Bronchiolitis Obliterans Syndrome

What participants receive

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

  • trigger point dry needlingDevice

    placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

  • Electrical StimulationDevice

    uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.

Study groups in NCT03539588
Study groupRoleWhat they receive
Treatment group 1Active comparatorIn this group participants will receive trigger point dry needling with electrical stimulation first and receive trigger point needling by itself second. Only MYOTECH dry needles will be used in this study. However we are not studying the equipment.
Receives: Device: trigger point dry needling; Device: Electrical Stimulation
Treatment Group 2Active comparatorIn this group the participants will receive trigger point dry needling first and receive trigger point dry needling with electrical stimulation second. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.
Receives: Device: trigger point dry needling; Device: Electrical Stimulation

What is being measured

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

  1. Numeric Pain Rating Scale to assess change

    an 11 point scale on which the participant will grade their pain

    Measured: Baseline and before and after each treatment session, duration per subject is approximately 3 weeks

Timeline

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

  1. First posted29 May 2018
  2. Study start12 Apr 2017
  3. Primary completion13 Nov 2017
  4. Study completion13 Nov 2017

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03539588
Sponsor's protocol ID
16-26
Status last verified
May 2018
First submitted
10 Mar 2017
Last updated
29 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Armed Forces Health Surveillance Center-AFHSC. Absolute and relative morbidity burdens attributable to various illnesses and injuries, U.S. Armed Forces, 2011. MSMR. 2012 Apr;19(4):4-8; discussion 8-9. No abstract available.

    PubMed 22587833

  • April 2012 - v19_n04 - v19_n04.pdf." Accessed May 18, 2016. https://www.afhsc.mil/documents/pubs/msmrs/2012/v19_n04.pdf#Page=2.

  • Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther HU, Melchart D, Willich SN. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006 Feb 27;166(4):450-7. doi: 10.1001/archinte.166.4.450.

    PubMed 16505266

  • Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.

    PubMed 23801002

  • Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.

    PubMed 19433697

  • Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

    PubMed 15928561

  • Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.

    PubMed 17909209

  • Cohen SP, Brown C, Kurihara C, Plunkett A, Nguyen C, Strassels SA. Diagnoses and factors associated with medical evacuation and return to duty among nonmilitary personnel participating in military operations in Iraq and Afghanistan. CMAJ. 2011 Mar 22;183(5):E289-95. doi: 10.1503/cmaj.100244. Epub 2011 Feb 14.

    PubMed 21324873

  • Cohen SP, Griffith S, Larkin TM, Villena F, Larkin R. Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers. Anesth Analg. 2005 Oct;101(4):1098-1103. doi: 10.1213/01.ane.0000169332.45209.cf.

    PubMed 16192528

  • Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil. 2001 Jul;82(7):986-92. doi: 10.1053/apmr.2001.24023.

    PubMed 11441390

  • Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2724-7. doi: 10.1097/01.brs.0000244618.06877.cd.

    PubMed 17077742

  • Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.

    PubMed 19124635

  • Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.

    PubMed 25143704

  • Eisenberg DM, Post DE, Davis RB, Connelly MT, Legedza AT, Hrbek AL, Prosser LA, Buring JE, Inui TS, Cherkin DC. Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2007 Jan 15;32(2):151-8. doi: 10.1097/01.brs.0000252697.07214.65.

    PubMed 17224808

  • Ernat J, Knox J, Orchowski J, Owens B. Incidence and risk factors for acute low back pain in active duty infantry. Mil Med. 2012 Nov;177(11):1348-51. doi: 10.7205/milmed-d-12-00183.

    PubMed 23198512

Questions about this trial

What is this clinical trial studying?

A study testing trigger point dry needling and Electrical Stimulation in people with Sub-acute and Chronic Low Back Pain, run by William Beaumont Army Medical Center 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 12 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 29 May 2018. 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?

Numeric Pain Rating Scale to assess change (time frame: Baseline and before and after each treatment session, duration per subject is approximately 3 weeks). 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 NCT03539588, which also lists 52 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 29 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in