Low Back PainNCT02250742
The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
A study testing dry needling in people with Low Back Pain, run by University of Haifa at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Dec 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60 years.
- Healthy individuals or individuals with main complaint of low back pain (LBP)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- dry needling
- Keywords
- ultrasound imaging, acupuncture, back muscles, spine, muscle strength
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
Also called acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Multifidus muscle thickness
Multifidus muscle thickness will be measured using diagnostic ultrasound imaging
Measured: baseline and Immediately after dry needling procedure at the same session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gali Dar, University of Haifa
- Investigators
- Gali Dar, PhD, Principal investigator, University of Haifa, Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250742
- Sponsor's protocol ID
- 045/11
- Status last verified
- May 2016
- First submitted
- 13 Jul 2014
- Last updated
- 24 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT02250742
- Acronym / sponsor ID
- 045/11
- Conditions
- Low Back Pain
- Keywords
- ultrasound imaging, acupuncture, back muscles, spine, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low back pain group | Experimental | Other: dry needlingDry 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. |
| healthy group | Active comparator | Other: dry needlingDry 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18-60 years.
- Healthy individuals or individuals with main complaint of low back pain (LBP)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingAlso: acupunctureDry 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. | Other | healthy group, low back pain group |
Primary outcome
Change in Multifidus muscle thickness
Time frame: baseline and Immediately after dry needling procedure at the same session
Multifidus muscle thickness will be measured using diagnostic ultrasound imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gali Dar, PhD principal investigator
University of Haifa, Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling in people with Low Back Pain, run by University of Haifa at 1 site in Israel.
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 2 inclusion and 7 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 24 May 2016. 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 Israel. 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?
Change in Multifidus muscle thickness (time frame: baseline and Immediately after dry needling procedure at the same session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2016.