Back to resultsThe Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
dry needling
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain focused on measuring ultrasound imaging, acupuncture, back muscles, spine, muscle strength
Eligibility Criteria
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.
Sites / Locations
- University of Haifa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low back pain group
healthy group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Multifidus muscle thickness
Multifidus muscle thickness will be measured using diagnostic ultrasound imaging
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02250742
Brief Title
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
Official Title
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
4. Oversight
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
ultrasound imaging, acupuncture, back muscles, spine, muscle strength
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low back pain group
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
dry needling
Other Intervention Name(s)
acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Multifidus muscle thickness
Description
Multifidus muscle thickness will be measured using diagnostic ultrasound imaging
Time Frame
baseline and Immediately after dry needling procedure at the same session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
University of Haifa, Department of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
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