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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02250742
Other study ID # 045/11
Secondary ID
Status Completed
Phase N/A
First received July 13, 2014
Last updated May 21, 2016
Start date September 2014
Est. completion date December 2015

Study information

Verified date May 2016
Source University of Haifa
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Description:

Dry needling of muscles is mainly used for the management of pain in musculoskeletal disorders. Yet, the association between dry needling and motor performance of muscles is still unclear.

This study aims to investigate the immediate effect of dry needling on lumbar multifidus muscles' function in healthy and low back pain subjects.

The sample will be divided into: low back pain group and control (healthy) group. Both groups will receive dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine). The needles will be left in situ for 10 minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and post- procedure during rest in a prone position and during contralateral active straight leg extension.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Age: 18-60 years.

- Healthy individuals or individuals with main complaint of low back pain (LBP)

Exclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
dry needling
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.

Locations

Country Name City State
Israel University of Haifa Haifa

Sponsors (1)

Lead Sponsor Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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