NCT03970486

Brief Summary

Although dry-needling with or without manipulation has shown to be a useful technique to reduce pain in patients with low back pain (LBP), it is unclear which of these two dry-needling techniques would have a greater effect on the lumboscaral multifidus (LM) muscle activation, which is essential in LBP rehabilitation. Therefore, the purposes of the study are: 1) to investigate whether or not dry-needling would change muscle activity of the LM muscles in asymptomatic healthy adults and in individuals with LBP, respectively, and 2) to compare the effects of two dry-needling techniques on LM muscle activation and pressure pain threshold (PPT) in asymptomatic healthy adults and individuals with LBP, respectively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 22, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

2.3 years

First QC Date

September 22, 2017

Last Update Submit

May 30, 2019

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • Change of Muscle activity

    An electroencephalographic (EMG) system with 4 wireless surface electrodes will be used to obtain muscle activities of the right and left lumbar multifidus muscles at the L5 and S2 levels.

    Before intervention, immediately after intervention and one week after intervention

  • Change of Pressure pain threshold

    A hand-held computerized pressure algometer will be used to determine the pressure pain threshold on the same 4 sites of EMG recording.

    Before intervention, immediately after intervention and one week after intervention

Study Arms (2)

Needle Manipulation

ACTIVE COMPARATOR

Participant will receive dry needling intervention with manipulation.

Procedure: Dry needling

In Situ

ACTIVE COMPARATOR

Participant will receive dry needling intervention without manipulation.

Procedure: Dry needling

Interventions

Dry needlingPROCEDURE

For the needle manipulation technique, the needle will be pulled in and out (sparrow pecking) and redirected in small angles (coning) for 5-10 seconds. For the in situ technique, the needles will stay (in situ) in the left and right lumbar multifidus muscles for 10 minutes after the insertion of the needle.

In SituNeedle Manipulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking adults and are 18 years of age or older.
  • For asymptomatic healthy adults: no existing low back pain (LBP) and no LBP in the past 6 months.
  • For individuals with LBP: existing LBP near the L5-S1 level with an average pain intensity score ≥ 2/10 in the past 24 hours (numeric pain rating scale of 0-10, 0 being no pain, 10 being unbearable pain)

You may not qualify if:

  • Bleeding disorders (e.g. hemophilia)
  • Use of anti-coagulants (e.g. Coumadin)
  • Previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis)
  • Cancer of the lower quadrant,
  • Neurological disorders
  • Allergic reaction to adhesive tape
  • Inability to obtain testing positions (prone lying)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (1)

  • Wang-Price S, Zafereo J, Couch Z, Brizzolara K, Heins T, Smith L. Short-term effects of two deep dry needling techniques on pressure pain thresholds and electromyographic amplitude of the lumbosacral multifidus in patients with low back pain - a randomized clinical trial. J Man Manip Ther. 2020 Dec;28(5):254-265. doi: 10.1080/10669817.2020.1714165. Epub 2020 Jan 17.

    PMID: 31960773DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Sharon Wang-Price

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Wang-Price, PhD

CONTACT

2146897715swang@twu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned into two dry needling treatment groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 22, 2017

First Posted

May 31, 2019

Study Start

September 22, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)