NCT02250742

Brief Summary

The study will establish data on the function of trunk muscles in healthy and low back pain patient's pre and post dry needling treatment. This will help in understanding the underlying mechanism of this treatment and reveal the effect of dry needling on muscle performance. Study hypothesis is that an improvement of back muscle function following dry needling procedure will be found.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable low-back-pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

July 13, 2014

Last Update Submit

May 21, 2016

Conditions

Keywords

ultrasound imagingacupunctureback musclesspinemuscle strength

Outcome Measures

Primary Outcomes (1)

  • Change in Multifidus muscle thickness

    Multifidus muscle thickness will be measured using diagnostic ultrasound imaging

    baseline and Immediately after dry needling procedure at the same session

Study Arms (2)

low back pain group

EXPERIMENTAL

Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utielized. The needles will be left in situ for 10 minutes.

Other: dry needling

healthy group

ACTIVE COMPARATOR

Dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine) will be utilized. The needles will be left in situ for 10 minutes.

Other: dry needling

Interventions

Dry needling uses traditional acupuncture needles without injecting any liquid. Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.

Also known as: acupuncture
healthy grouplow back pain group

Eligibility Criteria

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

You may qualify if:

  • Age: 18-60 years.
  • Healthy individuals or individuals with main complaint of low back pain (LBP)

You may not qualify if:

  • Patients with "red flags" for a serious spinal condition, for example: tumor, compression fractures, infection, cancer.
  • Signs of nerve root compression (positive straight leg raise \<45 degrees, decreased reflexes, decrease sensation or decreased strength in the lower extremities).
  • Pregnancy.
  • Previous surgery to the lumbar spine
  • History of congenital lumbar or pelvic anomalies
  • Physical therapy for LBP was provided in the 6 months prior to participation in the study
  • Patients who are unable to lie prone for 30 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry NeedlingAcupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Gali Dar, PhD

    University of Haifa, Department of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, researcher

Study Record Dates

First Submitted

July 13, 2014

First Posted

September 26, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations