Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Procedure: Dry needling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants will be assigned into two dry needling treatment groups. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Two Different Dry-Needling Techniques on Lumbar Multifidus Muscle Activation and Pressure Pain Threshold in Healthy Adults and Patients With Low Back Pain |
Actual Study Start Date : | September 22, 2017 |
Estimated Primary Completion Date : | December 31, 2019 |
Estimated Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
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Active Comparator: Needle Manipulation
Participant will receive dry needling intervention with manipulation.
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Procedure: Dry needling
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.
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Active Comparator: In Situ
Participant will receive dry needling intervention without manipulation.
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Procedure: Dry needling
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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria (for both the asymptomatic healthy and patients with low back pain groups) :
Contact: Sharon Wang-Price, PhD | 2146897715 | swang@twu.edu |
United States, Texas | |
Texas Woman's University | Recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Sharon Wang-Price, PhD 214-689-7715 swang@twu.edu |
Principal Investigator: | Sharon Wang-Price | Texas Woman's University |
Tracking Information | |||||
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First Submitted Date ICMJE | September 22, 2017 | ||||
First Posted Date ICMJE | May 31, 2019 | ||||
Last Update Posted Date | May 31, 2019 | ||||
Actual Study Start Date ICMJE | September 22, 2017 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of Two Different Dry-Needling Techniques for Low Back Pain | ||||
Official Title ICMJE | Effects of Two Different Dry-Needling Techniques on Lumbar Multifidus Muscle Activation and Pressure Pain Threshold in Healthy Adults and Patients With Low Back Pain | ||||
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. | ||||
Detailed Description |
PARTICIPANTS Participants will be recruited from local communities, including but not limited to Texas Woman's University (TWU) via flyers. The flyers will be posted at the TWU - Dallas campus, and Texas Physical Therapy Specialist - Dallas where one of the principal investigators, Zach Couch, works, and other community centers with approval. Participants who are interested in taking part in the study will be asked to call the investigators to schedule an appointment. The consent form will be presented at the beginning of the appointment. Eligible participants are English-speaking adults and are 18 years of age or older. Additional criteria for asymptomatic healthy adults include no existing LBP and no LBP in the past 6 months. Additional criteria for symptomatic participants include existing LBP near the L5-S2 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). Exclusion criteria for all participants include 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, or inability to obtain the testing position (prone lying). OUTCOME MEASURES
PROCEDURE After participants are informed of the risks, benefits and procedures of the study, they will be asked to sign a written consent form approved by the TWU Institutional Review Board - Dallas. Eligible participants will be asked to complete an intake form to collect their demographic data (age, gender, height, weight, occupation, hand dominance), past medical history, and questions related to their past history of pain if applicable (onset, injury mechanism if any, location, duration, type, and nature). The symptomatic participants also will be asked to rate their pain intensity at present, at worst, and at best in the past 24 hours using the NPRS. Participants who exhibit any of the exclusion criteria will be excluded from the study. Once the participants is determined to be eligible for the study, they will be asked to complete the Modified Oswestry Low Back Pain Disability Questionnaire (OSW), which will be used to determine their perceived disability and functional limitations due to LBP. Next, the EMG activity and PPTs will be collected from the painful side of the participants with LBP and the right side of the asymptomatic participants. When the symptomatic participants have bilateral LBP, the EMG activity and PPTs will be collected from the most painful side. If both sides are equally painful, a coin toss was performed to select the side (heads for the right side, tails for the left side). During the EMG and PPT testing, participants will be asked to lie in a prone position on an examination table with their arms on the sides. A pillow was placed under the participant's abdomen to flatten the lumbar lordotic curve and an inclinometer will be placed on the lumbosacral junction to ensure the lumbar curve ≤10°. The spinous processes of the L1-S2 and posterior superior iliac spine (PSIS) will be be identified by palpation and marked with a skin marker.
Immediately after the dry-needling intervention, the two outcome measures (EMG activity and PPTs) will be collected again. Each participant will also be asked about any presence of common adverse symptoms, including increased pain, nausea, dizziness and fatigue. If bleeding occurs, the participant will be informed of the occurrence. All participants will also be asked to avoid strenuous trunk activity or exercises for the following week. All participants will be scheduled to return in approximately 1 week for the final reassessment, including EMG activity and PPT testing. After return, all participants will be re-questioning about whether they experience any adverse symptoms after dry-needling. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants will be assigned into two dry needling treatment groups. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Low Back Pain | ||||
Intervention ICMJE | Procedure: Dry needling
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.
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Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria (for both the asymptomatic healthy and patients with low back pain groups) :
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03970486 | ||||
Other Study ID Numbers ICMJE | 19750 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sharon Wang-Price, Texas Woman's University | ||||
Study Sponsor ICMJE | Texas Woman's University | ||||
Collaborators ICMJE | University of Texas Southwestern Medical Center | ||||
Investigators ICMJE |
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PRS Account | Texas Woman's University | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |