Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527339
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RCT Analysis of the Effectiveness on Pain in Individuals With Nonspecific Low Back Pain by Adding a Percutaneous Vibratory Stimulus to Dry Needling in the Treatment of MTrPs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low back pain is one of the most common health issues worldwide and in most cases this pain is nonspecific low back pain NSLBP NSLBP is characterized by the inability to determine the real source of the pain and commonly presents with myofascial trigger points MTrPs in the muscles related to the lumbar region
One of the most widely used techniques for treating NSLBP by targeting MTrPs is dry needling DN a technique that involves inserting a needle to produce a mechanical effect capable of deactivating the MTrP and thereby alleviating its symptoms However some studies have concluded that other techniques are more effective than DN such as percutaneous electrolysis PE
When using the PE technique it appears that adding a galvanic current enhances the effects of DN Nonetheless this poses a greater risk to the patient as the galvanic current could damage nervous tissue if it comes into contact For this reason it is proposed to investigate whether other physical agents that are not electrical could enhance the effect of DN without increasing its risk This is the case for vibration a stimulus that has already been used successfully for the treatment of MTrPs allowing us to investigate whether adding vibration to DN introduces therapeutic capabilities that
Maintain or increase the effectiveness of DN in terms of pain and functional capacity
Do not add risks for the patient unlike PE
Are less painful than DN and cause less post-needling pain than that generated after successive needle insertions with DN Emphasizing these adverse effects is necessary since most clinical trials do not report these variables which is fundamental for describing the safety of invasive techniques
Following this idea the present project will analyze a new invasive therapy for the treatment of MTrPs dry needling with vibratory stimulus DNV for which the following hypotheses are proposed
DNV instead of using an electrical stimulus like PE that could cause damage to some tissues will apply vibration to the DN needles to increase the mechanical stimulus exerted on the MTrP expecting greater benefits in terms of pain functional capacity muscle strength and other variables of interest in individuals with NSLBP and possibly requiring less treatment time than DN
In DN the repeated insertions and withdrawals of the needle in the MTrP provoke a hemorrhagic and inflammatory reaction that translates into hypersensitivity and microscopic tissue injury in the muscle causing pain during treatment and post-needling pain for the following 24-32 hours Another study showed that PE caused less post-needling pain than DN which may be due to the fact that unlike DN it is common in PE to only perform a single puncture with each needle and not mobilize them
The methodology for DNV will be the same as for PE with a single puncture and no needle manipulation so it is expected that DNV being less invasive than DN will reduce pain during treatment and post-needling pain compared to that generated by DN There are studies that support this hypothesis concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation
One of the most widely used techniques for treating NSLBP by targeting MTrPs is dry needling DN a technique that involves inserting a needle to produce a mechanical effect capable of deactivating the MTrP and thereby alleviating its symptoms However some studies have concluded that other techniques are more effective than DN such as percutaneous electrolysis PE
When using the PE technique it appears that adding a galvanic current enhances the effects of DN Nonetheless this poses a greater risk to the patient as the galvanic current could damage nervous tissue if it comes into contact For this reason it is proposed to investigate whether other physical agents that are not electrical could enhance the effect of DN without increasing its risk This is the case for vibration a stimulus that has already been used successfully for the treatment of MTrPs allowing us to investigate whether adding vibration to DN introduces therapeutic capabilities that
Maintain or increase the effectiveness of DN in terms of pain and functional capacity
Do not add risks for the patient unlike PE
Are less painful than DN and cause less post-needling pain than that generated after successive needle insertions with DN Emphasizing these adverse effects is necessary since most clinical trials do not report these variables which is fundamental for describing the safety of invasive techniques
Following this idea the present project will analyze a new invasive therapy for the treatment of MTrPs dry needling with vibratory stimulus DNV for which the following hypotheses are proposed
DNV instead of using an electrical stimulus like PE that could cause damage to some tissues will apply vibration to the DN needles to increase the mechanical stimulus exerted on the MTrP expecting greater benefits in terms of pain functional capacity muscle strength and other variables of interest in individuals with NSLBP and possibly requiring less treatment time than DN
In DN the repeated insertions and withdrawals of the needle in the MTrP provoke a hemorrhagic and inflammatory reaction that translates into hypersensitivity and microscopic tissue injury in the muscle causing pain during treatment and post-needling pain for the following 24-32 hours Another study showed that PE caused less post-needling pain than DN which may be due to the fact that unlike DN it is common in PE to only perform a single puncture with each needle and not mobilize them
The methodology for DNV will be the same as for PE with a single puncture and no needle manipulation so it is expected that DNV being less invasive than DN will reduce pain during treatment and post-needling pain compared to that generated by DN There are studies that support this hypothesis concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation
Detailed Description:
This study aims to evaluate the efficacy of a new invasive therapy for treating MTrPs dry needling with vibratory stimulus DNV The following hypotheses are proposed
DNV will utilize vibration on the dry needling needles instead of an electrical stimulus like in percutaneous electrolysis PE which could potentially damage some tissues The expectation is that DNV will increase the mechanical stimulus applied to the MTrP yielding greater benefits in terms of pain relief functional capacity muscle strength and other variables of interest in individuals with NSLBP possibly requiring less treatment time compared to DN alone
In DN repeated insertions and withdrawals of the needle into the MTrP provoke a hemorrhagic and inflammatory reaction that results in hypersensitivity and microscopic tissue injury in the muscle causing pain during treatment and post-needling pain for the next 24-32 hours A study showed that PE caused less post-needling pain than DN likely because PE typically involves a single puncture per needle without needle manipulation
DNV will follow the same methodology as PE with a single puncture and no needle manipulation Thus it is expected that DNV being less invasive than DN will reduce pain during treatment and post-needling pain compared to DN A study supports this hypothesis concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation
To test these hypotheses a randomized clinical trial will be conducted RCT Analysis of the Effectiveness on Pain in Individuals with Nonspecific Low Back Pain by Adding a Percutaneous Vibratory Stimulus to Dry Needling in the Treatment of MTrPs
EXPECTED RESULTS This initial study will provide the first data on DNV focusing on whether DNV is easy to apply well-tolerated by patients and shows effects similar to or better than DN in reducing NSLBP
METHODOLOGY
Instrumentation and Evaluation Method A group of specialized physiotherapists will evaluate each participant for MTrPs in muscles related to NSLBP Identified MTrPs will be included in the study
Variables For this initial RCT only the main variables will be considered NSLBP pain during treatment and post-needling pain These will be evaluated using the Numeric Pain Rating Scale NPRS
Intervention Participants will be randomized into two groups DN without vibration considered the control group and DNV vibration for 10 minutes
Follow-up NSLBP will be evaluated before and after the intervention and at 24 and 48 hours Pain during treatment will be recorded immediately after the intervention Post-treatment pain will be evaluated 48 hours later asking each participant how long post-needling pain lasted if it occurred
TRANSFER AND DISSEMINATION OF RESULTS The development of this treatment technique for MTrPs will involve creating a know-how that encompasses all knowledge and application methodology related to DNV This dissertation will demonstrate the effectiveness and cost-effectiveness of DNV but this will only be the starting point of the know-how as further research will be necessary to address current uncertainties eg does the entire population and all musculature respond the same way and to refine the application methodology optimal dose of timeintensityfrequency of vibration possible combination with physical exercise etc
Once the know-how has been validated and scientifically supported efforts will be made to disseminate it Through presentations courses and training sessions the DNV technique will be promoted to advance clinical practice among physiotherapists An example of a successfully implemented know-how in physiotherapy is the DNHS technique wwwdnhses a dry needling technique specifically developed for neurological patients by Dr Pablo Herrero the director of the doctoral thesis in which this study is included
When the know-how of the DNV technique gains popularity among health professionals its economic potential will be exploited Similar to other treatment techniques like PE specific devices for DNV application will be developed and training sessions will be conducted to ensure proper use of the technique This will generate economic returns for the researchers and promoters involved in the development of the DNV technique
DNV will utilize vibration on the dry needling needles instead of an electrical stimulus like in percutaneous electrolysis PE which could potentially damage some tissues The expectation is that DNV will increase the mechanical stimulus applied to the MTrP yielding greater benefits in terms of pain relief functional capacity muscle strength and other variables of interest in individuals with NSLBP possibly requiring less treatment time compared to DN alone
In DN repeated insertions and withdrawals of the needle into the MTrP provoke a hemorrhagic and inflammatory reaction that results in hypersensitivity and microscopic tissue injury in the muscle causing pain during treatment and post-needling pain for the next 24-32 hours A study showed that PE caused less post-needling pain than DN likely because PE typically involves a single puncture per needle without needle manipulation
DNV will follow the same methodology as PE with a single puncture and no needle manipulation Thus it is expected that DNV being less invasive than DN will reduce pain during treatment and post-needling pain compared to DN A study supports this hypothesis concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation
To test these hypotheses a randomized clinical trial will be conducted RCT Analysis of the Effectiveness on Pain in Individuals with Nonspecific Low Back Pain by Adding a Percutaneous Vibratory Stimulus to Dry Needling in the Treatment of MTrPs
EXPECTED RESULTS This initial study will provide the first data on DNV focusing on whether DNV is easy to apply well-tolerated by patients and shows effects similar to or better than DN in reducing NSLBP
METHODOLOGY
Instrumentation and Evaluation Method A group of specialized physiotherapists will evaluate each participant for MTrPs in muscles related to NSLBP Identified MTrPs will be included in the study
Variables For this initial RCT only the main variables will be considered NSLBP pain during treatment and post-needling pain These will be evaluated using the Numeric Pain Rating Scale NPRS
Intervention Participants will be randomized into two groups DN without vibration considered the control group and DNV vibration for 10 minutes
Follow-up NSLBP will be evaluated before and after the intervention and at 24 and 48 hours Pain during treatment will be recorded immediately after the intervention Post-treatment pain will be evaluated 48 hours later asking each participant how long post-needling pain lasted if it occurred
TRANSFER AND DISSEMINATION OF RESULTS The development of this treatment technique for MTrPs will involve creating a know-how that encompasses all knowledge and application methodology related to DNV This dissertation will demonstrate the effectiveness and cost-effectiveness of DNV but this will only be the starting point of the know-how as further research will be necessary to address current uncertainties eg does the entire population and all musculature respond the same way and to refine the application methodology optimal dose of timeintensityfrequency of vibration possible combination with physical exercise etc
Once the know-how has been validated and scientifically supported efforts will be made to disseminate it Through presentations courses and training sessions the DNV technique will be promoted to advance clinical practice among physiotherapists An example of a successfully implemented know-how in physiotherapy is the DNHS technique wwwdnhses a dry needling technique specifically developed for neurological patients by Dr Pablo Herrero the director of the doctoral thesis in which this study is included
When the know-how of the DNV technique gains popularity among health professionals its economic potential will be exploited Similar to other treatment techniques like PE specific devices for DNV application will be developed and training sessions will be conducted to ensure proper use of the technique This will generate economic returns for the researchers and promoters involved in the development of the DNV technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None