Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453408
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain
Sponsor:
University of Alcala
Organization:
University of Alcala
Study Overview
Official Title:
Validation of a Placebo Dry Needling Protocol in Patients With Non-specific Neck Pain a Randomised Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This study aims to validate a placebo dry needling protocol for patients with non-specific neck pain and investigate whether prior experience with dry needling affects their ability to distinguish between real and placebo treatments and how this impacts outcomes Seventy participants aged 18-65 will be recruited and divided into two groups based on their previous dry needling experience then randomized into real or placebo needling groups
Assessment will be carried out before treatment immediately after the procedure and one week later Pain intensity pain threshold to pressure cervical range of motion level of disability and presence of central sensitisation will also be measured
Assessment will be carried out before treatment immediately after the procedure and one week later Pain intensity pain threshold to pressure cervical range of motion level of disability and presence of central sensitisation will also be measured
Detailed Description:
Background There is currently no valid and reliable method available to perform a placebo dry needling protocol in patients with non-specific neck pain The lack of uniformity and validity in placebo dry needling methods hinders research on the specific effects of this technique In addition there is no solid evidence on how patients previous experiences affect their expectations of treatment An effective placebo dry needling protocol is essential for future research on the effectiveness of dry needling in randomised controlled clinical trials
Objective The main objective of this study is to validate a placebo dry needling protocol The secondary objective is to examine whether the patients previous experience with dry needling influences their ability to discern between having received a real or placebo needling and how this impacts on the outcomes of the intervention
Material and method 70 participants aged 18-65 years with non-specific neck pain who meet the inclusion criteria will be recruited They will be assigned to one of two groups those who have previously received dry needling and those who have not Thereafter members of each group will be randomised and assigned to either the real dry needling or placebo group Assessment will be carried out before treatment immediately after the procedure and one week later Pain intensity pain threshold to pressure cervical range of motion level of disability and presence of central sensitisation will also be measured
Objective The main objective of this study is to validate a placebo dry needling protocol The secondary objective is to examine whether the patients previous experience with dry needling influences their ability to discern between having received a real or placebo needling and how this impacts on the outcomes of the intervention
Material and method 70 participants aged 18-65 years with non-specific neck pain who meet the inclusion criteria will be recruited They will be assigned to one of two groups those who have previously received dry needling and those who have not Thereafter members of each group will be randomised and assigned to either the real dry needling or placebo group Assessment will be carried out before treatment immediately after the procedure and one week later Pain intensity pain threshold to pressure cervical range of motion level of disability and presence of central sensitisation will also be measured
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