Healthy ParticipantsUS-DNNCT02824991
Ultrasonography Detection of Local Twitch Response During Dry Needling
A study testing detection of local twitch response intensities during dry needling in people with Healthy Participants, run by University of Malaga.
Trial summary
Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with the purpose of obtaining local twitch responses (LTRs), which are highly effective in releasing MTrPs. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- detection of local twitch response intensities during dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Apr 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
Who cannot join
- Participants were excluded if they presented any history of musculoskeletal pain in the last six months, pathological conditions of the vertebral column, neurological diseases, respiratory diseases, a systemic rheumatic condition, heritable connective tissue disorders, and/or any previous abdominal surgery
About this study
Official title: Semi-Automatic Ultrasonography Detection of Local Twitch Response Intensities During Dry Needling: Implications on Joint Range of Motion
Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with the purpose of obtaining local twitch responses (LTRs), which are highly effective in releasing MTrPs. In DN procedures the mechanisms associated with LTRs and the LTR intensities required for optimal clinical results are poorly understood, especially in relation to range of motion after intervention. Therefore, evaluating the intensity of LTRs is relevant for implementing DN in different clinical settings, such as in patients with muscular or neurological dysfunctions. One way to assess muscle contractions and LTRs is through ultrasound video analysis.
The aim of this report was to evaluate the reliability of semi-automatic LTR intensities tracking during dry needling by assessing ultrasound signals with an image processing method, in addition to evaluating the relationship between LTR intensities and muscle elasticity.
Method: Young males without signs or symptoms of musculoskeletal pain were included. Primary outcome measure was the LTR intensities determined by percentage change of muscle thickness. The secondary outcome measures were the muscle elasticity of medial gastrocnemius and hamstring, previous and posterior DN in both lower limbs for each subject. Three LTRs, detected by a physical therapist and ultrasound assessment, were induced by inserting a filament needle into muscle latent trigger points in medial gastrocnemius. The intensities of LTRs were measured by assessing ultrasound images using an optical flow method and through comparisons with manual detection.
Read the detailed description
The aim of this report was to evaluate the reliability of semi-automatically tracking local twitch responses (LTR) intensities during dry needling by assessing ultrasound signals with an optical flow method designed to estimate movement of ROIs, in addition to evaluating the relationship between LTR intensities and muscle elasticity.
Experimental protocol and measurements For each subject, the ROM of the medial gastrocnemius (MG) and hamstring (HA) was determined in both lower limbs using weight bearing and the active knee extension test, respectively, using a universal goniometer. For the knee extension test, 180° were subtracted from the obtained range, and the values were presented as negative. Both tests present excellent intra- and inter-rater reliability.
All participants were placed in a prone position with the ankle locked at 90º. Latent MTrPs were identified in both MG using according the presence of a palpable taut band and hypersensitive spot in the palpable taut band as diagnostic criteria. The ultrasound transducer was positioned over the MG muscle using a fixing device that was composed of a thermoplastic polymer, with enough space for the dry needling (DN) technique to be performed.
The deep DN was administered by a physical therapist with three years of experience in the technique. The ultrasound video (SonoSite Titan; Sonosite, Bothell, WA, USA) was recorded at 60 frames per second captured through an external capture device from Epiphan Systems Inc. (Ottawa, Ontario, Canada). According to the perception of the physical therapist and the ultrasound assessment, the filament needle was inserted into the MTrP to achieve three LTRs. Posterior to DN application, the ROMs of the MG and HA were measured.
The recorded ultrasound video was examined by the Camtasia software (Tech-Smith Corp, Okemos, MI, USA) to select three LTRs for latter analysis. Each LTR was tracked by the Lucas-Kanade optical flow (LKOF) algorithm with affine optic flow extension [12]. All analyses were performed using the Matlab® 2014 software (Mathworks Inc., Natick, MA, USA). For tracking muscle thickness, two ROIs (size 250 x 70 pixels) positioned on the superficial and deep aponeurosis were manually selected.
Muscle thickness was normalized as a percentage of recruitment using the following equation: (thickness contracted-thickness rest/thickness rest)*100. For manual tracking of LTRs, the recorded ultrasound video was analyzed in the Matlab® 2014 software. Peak muscle thickness was determined by selecting muscle borders using hyperechoic aponeurosis lines.
- Conditions
- Healthy Participants
- Being tested
- detection of local twitch response intensities during dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of local twitch response intensities during dry needlingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Deep Dry Needling | Experimental | Deep Dry Needling (DN) with the purpose of obtaining local twitch responses (LTRs). Description: Latent MTrPs were identified in both MG using according the presence of a palpable taut band and hypersensitive spot in the palpable taut band as diagnostic criteria.
The deep DN was administered by a physical therapist with three years of experience in the technique. The ultrasound video (SonoSite Titan; Sonosite, Bothell, WA, USA) was recorded at 60 frames per second captured through an external capture device from Epiphan Systems Inc. (Ottawa, Ontario, Canada). According to the perception of the physical therapist and the ultrasound assessment, the filament needle was inserted into the MTrP to achieve three LTRs. Posterior to DN application, the ROMs of the MG and HA were measured Receives: Procedure: detection of local twitch response intensities during dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of local twitch responses to Dry Needling with Ultrasonomiography 30 fps
acute effect based in Range of Interest (RoI) of deep fascia reference
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Clinimetric Tool
stratificaction of size of local responses to dry needling thicknessbased, reliability and construct validity study
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Antonio Cuesta-Vargas, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824991
- Sponsor's protocol ID
- CH-Sp-01
- Acronym
- US-DN
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-Automatic Ultrasonography Detection of Local Twitch Response Intensities During Dry Needling: Implications on Joint Range of Motion
- ClinicalTrials.gov ID
- NCT02824991
- Acronym / sponsor ID
- US-DN / CH-Sp-01
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- University of Chile
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Jul 2016 (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.
Background: One treatment of Muscle trigger points (MTrPs) is deep dry needling (DN) with the purpose of obtaining local twitch responses (LTRs), which are highly effective in releasing MTrPs. In DN procedures the mechanisms associated with LTRs and the LTR intensities required for optimal clinical results are poorly understood, especially in relation to range of motion after intervention. Therefore, evaluating the intensity of LTRs is relevant for implementing DN in different clinical settings, such as in patients with muscular or neurological dysfunctions. One way to assess muscle contractions and LTRs is through ultrasound video analysis.
The aim of this report was to evaluate the reliability of semi-automatic LTR intensities tracking during dry needling by assessing ultrasound signals with an image processing method, in addition to evaluating the relationship between LTR intensities and muscle elasticity.
Method: Young males without signs or symptoms of musculoskeletal pain were included. Primary outcome measure was the LTR intensities determined by percentage change of muscle thickness. The secondary outcome measures were the muscle elasticity of medial gastrocnemius and hamstring, previous and posterior DN in both lower limbs for each subject. Three LTRs, detected by a physical therapist and ultrasound assessment, were induced by inserting a filament needle into muscle latent trigger points in medial gastrocnemius. The intensities of LTRs were measured by assessing ultrasound images using an optical flow method and through comparisons with manual detection.
Detailed description
The aim of this report was to evaluate the reliability of semi-automatically tracking local twitch responses (LTR) intensities during dry needling by assessing ultrasound signals with an optical flow method designed to estimate movement of ROIs, in addition to evaluating the relationship between LTR intensities and muscle elasticity.
Experimental protocol and measurements For each subject, the ROM of the medial gastrocnemius (MG) and hamstring (HA) was determined in both lower limbs using weight bearing and the active knee extension test, respectively, using a universal goniometer. For the knee extension test, 180° were subtracted from the obtained range, and the values were presented as negative. Both tests present excellent intra- and inter-rater reliability.
All participants were placed in a prone position with the ankle locked at 90º. Latent MTrPs were identified in both MG using according the presence of a palpable taut band and hypersensitive spot in the palpable taut band as diagnostic criteria. The ultrasound transducer was positioned over the MG muscle using a fixing device that was composed of a thermoplastic polymer, with enough space for the dry needling (DN) technique to be performed.
The deep DN was administered by a physical therapist with three years of experience in the technique. The ultrasound video (SonoSite Titan; Sonosite, Bothell, WA, USA) was recorded at 60 frames per second captured through an external capture device from Epiphan Systems Inc. (Ottawa, Ontario, Canada). According to the perception of the physical therapist and the ultrasound assessment, the filament needle was inserted into the MTrP to achieve three LTRs. Posterior to DN application, the ROMs of the MG and HA were measured.
The recorded ultrasound video was examined by the Camtasia software (Tech-Smith Corp, Okemos, MI, USA) to select three LTRs for latter analysis. Each LTR was tracked by the Lucas-Kanade optical flow (LKOF) algorithm with affine optic flow extension [12]. All analyses were performed using the Matlab® 2014 software (Mathworks Inc., Natick, MA, USA). For tracking muscle thickness, two ROIs (size 250 x 70 pixels) positioned on the superficial and deep aponeurosis were manually selected.
Muscle thickness was normalized as a percentage of recruitment using the following equation: (thickness contracted-thickness rest/thickness rest)*100. For manual tracking of LTRs, the recorded ultrasound video was analyzed in the Matlab® 2014 software. Peak muscle thickness was determined by selecting muscle borders using hyperechoic aponeurosis lines.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Dry Needling | Experimental | Procedure: detection of local twitch response intensities during dry needlingDeep Dry Needling (DN) with the purpose of obtaining local twitch responses (LTRs). Description: Latent MTrPs were identified in both MG using according the presence of a palpable taut band and hypersensitive spot in the palpable taut band as diagnostic criteria. The deep DN was administered by a physical therapist with three years of experience in the technique. The ultrasound video (SonoSite Titan; Sonosite, Bothell, WA, USA) was recorded at 60 frames per second captured through an external capture device from Epiphan Systems Inc. (Ottawa, Ontario, Canada). According to the perception of the physical therapist and the ultrasound assessment, the filament needle was inserted into the MTrP to achieve three LTRs. Posterior to DN application, the ROMs of the MG and HA were measured |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (1 listed)
- Participants were excluded if they presented any history of musculoskeletal pain in the last six months, pathological conditions of the vertebral column, neurological diseases, respiratory diseases, a systemic rheumatic condition, heritable connective tissue disorders, and/or any previous abdominal surgery
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 |
|---|---|---|
| detection of local twitch response intensities during dry needling | Procedure or surgery | Deep Dry Needling |
Primary outcome
Size of local twitch responses to Dry Needling with Ultrasonomiography 30 fps
Time frame: through study completion, an average of 1 year
acute effect based in Range of Interest (RoI) of deep fascia reference
1 secondary outcome
Clinimetric Tool
Time frame: through study completion, an average of 1 year
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 1 Dec 2023.
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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.
Antonio Cuesta-Vargas, PhD principal investigator
University of Malaga
Questions about this trial
What is this clinical trial studying?
A study testing detection of local twitch response intensities during dry needling in people with Healthy Participants, run by University of Malaga.
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 1 inclusion and 1 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Size of local twitch responses to Dry Needling with Ultrasonomiography 30 fps (time frame: through study completion, an average of 1 year). 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 1 Dec 2023.