Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758065
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2021-02-08
Brief Title:
Effectiveness of Radial Pressure Waves Therapy in the Treatment of Non-Specific Neck Pain rPWT
Sponsor:
Universidad Pontificia Comillas
Organization:
Universidad Pontificia Comillas
Study Overview
Official Title:
Effectiveness of the Application of Radial Pressure Waves Together With a Manual Therapy Protocol and Therapeutic Exercise in the Treatment of Non-Specific Neck Pain a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rPWT
Brief Summary:
The present study aims to know the effectiveness of radial pressure wave therapy in the treatment of people with nonspecific neck pain The study hypothesis is that including radial pressure wave therapy in a protocol based on manual therapy and therapeutic exercise is more effective than the protocol alone for the treatment of nonspecific neck pain
Participants will be randomly assigned into 2 groups one will be applied only the manual therapy and exercise protocol and the other the same protocol plus shock wave therapy Data related to the pathology will be collected and compared between the two groups to determine which treatment is more effective
Participants will be randomly assigned into 2 groups one will be applied only the manual therapy and exercise protocol and the other the same protocol plus shock wave therapy Data related to the pathology will be collected and compared between the two groups to determine which treatment is more effective
Detailed Description:
Nonspecific neck pain is one of the main reasons for outpatient physiotherapy consultation and due to its multifactorial origin there are numerous approaches without a consensus on the effectiveness of the different treatments The most recent systematic reviews show significant evidence about the efficacy of the combination of Manual Therapy MT and exercise on pain muscle elasticity posture and functionality in patients suffering from neck pain
During muscle evaluation it is common to find painful pressure points that are not spontaneously These asymptomatic areas painful when pressed appear as areas with loss of elasticity when evaluated with quantitative elastography shear wave which influences their contractile capacity and their ability to develop strength together with the inhibition caused by the pain The accumulation of cytotoxic and nociceptive substances derived from the excess activity could be the cause of the shortening of muscle fibers so an increase in vascularity could help improve their drainage and normalize their elasticity and functionality
Radial shock waves have been shown to be effective in angiogenesis increasing vascularity and oxygen saturation of treated areas so it could be a useful tool to help solve this problem
This study aims to determine the effectiveness of radial shock waves to locate and treat the areas of loss of elasticity found during muscle evaluation combined with a MT and exercise protocol compared to the manual therapy and exercise protocol itself To do this participants will be randomly assigned into 2 groups one will be applied only the manual therapy and exercise protocol and the other the same protocol plus shock wave therapy The data collected will be compared between the two groups An intention-to-treat statistical analysis will be performed
Objective
To determine the influence of the application of radial pressure waves together with the usual Physiotherapy treatment on the elasticity of muscle tissue pain the amplitude and harmony of cervical movements strength and quality of life in people with nonspecific neck pain
Methods
The research will begin at the end of February 2021 and will be carried out in the biomechanics and movement analysis laboratory of the San Juan de Dios School of Nursing and Physiotherapy Comillas Pontifical University and at the Cimeg Madrid facilities
A preliminary pilot study will be carried out with 10 volunteers with nonspecific neck pain in order to calculate the sample size appropriate to the proposed objectives
Participants will be randomly assigned using sealed envelopes to one of the two groups
Group 1 will perform a conventional treatment protocol of physical therapy based on manual therapy and therapeutic exercise for 4 weeks Participants will go to the facilities once a week to get 1 session of manual therapy treatment based on the Maitland Concept on the cervical and thoracic spine Besides this they will perform 3 sessions a week of home-based cervical therapeutic exercise
Group 2 will perform the same treatment protocol as Group 1 and in addition will get a radial pressure waves session in the pressure sore spots found in the muscle evaluation
Muscle Elasticity Pain Pressure Threshold Cervical Pain Active Range of Motion the harmony of movement Shoulder lift strength Quality of life Disability and Kinesiophobia will be measured before and after treatment at 4 weeks at one month and at three months after the start of the study while demographic variables Number of sore spots Age Sex Dominance Height Weight Body Mass Index BMI Educational level Work Activity and Sports Activity will only be measured at the baseline
During muscle evaluation it is common to find painful pressure points that are not spontaneously These asymptomatic areas painful when pressed appear as areas with loss of elasticity when evaluated with quantitative elastography shear wave which influences their contractile capacity and their ability to develop strength together with the inhibition caused by the pain The accumulation of cytotoxic and nociceptive substances derived from the excess activity could be the cause of the shortening of muscle fibers so an increase in vascularity could help improve their drainage and normalize their elasticity and functionality
Radial shock waves have been shown to be effective in angiogenesis increasing vascularity and oxygen saturation of treated areas so it could be a useful tool to help solve this problem
This study aims to determine the effectiveness of radial shock waves to locate and treat the areas of loss of elasticity found during muscle evaluation combined with a MT and exercise protocol compared to the manual therapy and exercise protocol itself To do this participants will be randomly assigned into 2 groups one will be applied only the manual therapy and exercise protocol and the other the same protocol plus shock wave therapy The data collected will be compared between the two groups An intention-to-treat statistical analysis will be performed
Objective
To determine the influence of the application of radial pressure waves together with the usual Physiotherapy treatment on the elasticity of muscle tissue pain the amplitude and harmony of cervical movements strength and quality of life in people with nonspecific neck pain
Methods
The research will begin at the end of February 2021 and will be carried out in the biomechanics and movement analysis laboratory of the San Juan de Dios School of Nursing and Physiotherapy Comillas Pontifical University and at the Cimeg Madrid facilities
A preliminary pilot study will be carried out with 10 volunteers with nonspecific neck pain in order to calculate the sample size appropriate to the proposed objectives
Participants will be randomly assigned using sealed envelopes to one of the two groups
Group 1 will perform a conventional treatment protocol of physical therapy based on manual therapy and therapeutic exercise for 4 weeks Participants will go to the facilities once a week to get 1 session of manual therapy treatment based on the Maitland Concept on the cervical and thoracic spine Besides this they will perform 3 sessions a week of home-based cervical therapeutic exercise
Group 2 will perform the same treatment protocol as Group 1 and in addition will get a radial pressure waves session in the pressure sore spots found in the muscle evaluation
Muscle Elasticity Pain Pressure Threshold Cervical Pain Active Range of Motion the harmony of movement Shoulder lift strength Quality of life Disability and Kinesiophobia will be measured before and after treatment at 4 weeks at one month and at three months after the start of the study while demographic variables Number of sore spots Age Sex Dominance Height Weight Body Mass Index BMI Educational level Work Activity and Sports Activity will only be measured at the baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None