Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT06780904
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Efficacy of Dry Needling Combined with Passive Stretching and Muscle Energy Technique on Myofascial Trigger Points
Sponsor:
University of Peradeniya
Organization:
Study Overview
Official Title:
Comparing the Efficacy of Dry Needling Combined with Passive Stretching and Muscle Energy Technique on Upper Trapezius Myofascial Trigger Points Associated with Neck Pain
Status:
RECRUITING
Status Verified Date:
2024-12
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:
None
Brief Summary:
The goal of this clinical trial is to assess and compare the efficacy of dry needling (minimally invasive treatment by using a tiny needle) combined with two types of stretching techniques in patients with neck pain for more than 3 months. The main questions it aims to answer are:
Which combination of treatment will 1.give faster relief of pain? 2.improve neck range of motion? and 3.improve disability level of a person with neck pain.
Participants who are interested will be selected according to eligibility criteria. Participants will be divided into two groups. Initially researcher will assess and interview the participants. Two groups will receive two different combinations of interventions. Pre and post measurements will be obtained and then treatment efficacy will be assessed.
Which combination of treatment will 1.give faster relief of pain? 2.improve neck range of motion? and 3.improve disability level of a person with neck pain.
Participants who are interested will be selected according to eligibility criteria. Participants will be divided into two groups. Initially researcher will assess and interview the participants. Two groups will receive two different combinations of interventions. Pre and post measurements will be obtained and then treatment efficacy will be assessed.
Detailed Description:
46 participants who are interested in this study will be recruited by using convenient sampling method and according to the inclusion and exclusion criteria. Participants then will be divided into two groups by using opaque sealed envelop method.
Initially participants will be interviewed an outcome measures will be taken. As outcome measures Pain will be assessed by using Visual Analogue Scale (VAS), Disability level will be assessed by using Neck Disability Index(NDI), and Neck Range of Motion will be measured by using Universal Goniometer. Participants will receive interventions, two times per week for two weeks. Soon after the last intervention, same outcome measures will be taken again.
Statistical Package for Social Science (SPSS) version 27 (IBM, USA) for Windows will be used for data analysis. The data will be examined using exploratory statistics, and the distributions will be inspected for violations of normality using graphical methods and the Shapiro-Wilk test. Descriptive statistics of the demographic variables and test measurements will be calculated. Based on the satisfaction or violation of normal distribution assumptions, pain intensity (VAS), neck ROMs, pain intensity, and Neck Disability Index (NDI) will be analyzed using parametric or non-parametric tests. Baseline data for pain intensity, neck ROMs and NDI and pain intensity will be compared between the two intervention groups using paired t-test or Wilcoxon signed-rank test. The difference-in changes in each outcome relative to the baseline between intervention groups will be compared using paired t-test or Wilcoxon signed-rank test
Initially participants will be interviewed an outcome measures will be taken. As outcome measures Pain will be assessed by using Visual Analogue Scale (VAS), Disability level will be assessed by using Neck Disability Index(NDI), and Neck Range of Motion will be measured by using Universal Goniometer. Participants will receive interventions, two times per week for two weeks. Soon after the last intervention, same outcome measures will be taken again.
Statistical Package for Social Science (SPSS) version 27 (IBM, USA) for Windows will be used for data analysis. The data will be examined using exploratory statistics, and the distributions will be inspected for violations of normality using graphical methods and the Shapiro-Wilk test. Descriptive statistics of the demographic variables and test measurements will be calculated. Based on the satisfaction or violation of normal distribution assumptions, pain intensity (VAS), neck ROMs, pain intensity, and Neck Disability Index (NDI) will be analyzed using parametric or non-parametric tests. Baseline data for pain intensity, neck ROMs and NDI and pain intensity will be compared between the two intervention groups using paired t-test or Wilcoxon signed-rank test. The difference-in changes in each outcome relative to the baseline between intervention groups will be compared using paired t-test or Wilcoxon signed-rank test
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: