Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03576846
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2018-06-20
Brief Title:
Spinal Pain and Autonomic Responses to Chiropractic Care
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain and the Predictive Value of Conditioned Pain Modulation
Status:
COMPLETED
Status Verified Date:
2020-09
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:
SPARC
Brief Summary:
This randomized single-blinded study will investigate the effects of Spinal Manipulative Therapy on Heart Rate Variability and Pain Sensitivity in a population of patients with recurrent and persistent neck pain Alongside the study will also develop a clinical test for Conditioned Pain Modulation and investigate its predictive properties
Detailed Description:
Previously Spinal Manipulative Therapy SMT was thought to mechanically affect the restoration of muscular and joint function by normalising muscle tension and joint mobility However recent research has suggested that SMT may be influencing the incomingascending pain signals andor the excitability of the central pain regulating mechanisms People with chronic neckshoulder pain have been found to have a disturbance of the Autonomic Nervous System ANS Little is known about the changes in the ANS and its relation to changes in pain in a series of treatments conducted in a clinical setting
This multicentre randomized controlled clinical trial will be carried out in multimodal primary care clinics where both physiotherapists and chiropractors are consulted for musculoskeletal issues are selected to minimize selection bias from the patients pre-desired treatment modality
The subjects will be recruited among patients seeking care for persistent or recurrent Neck pain NP either self-selected or through referrals from general practitioners in the local areal The aim is to study the effect of SMT and stretching exercises compared to stretching exercises alone two well-known interventions for NP during a two-week treatment regimen
The primary outcome is the activity of the autonomic nervous system Heart Rate Variability HRV but also Conditioned Pain Modulation CPM will be measured HRV and CPM will be measured at baseline prior to the third treatment and after the fourth treatment
The subjective pain experience will be investigated by using two different instruments accessing pain intensity and the affective quality of pain asked at the assessments during the two weeks of treatment and 2 months after the period of intervention ends
Highly structured data collection procedures should provide reliable data to answer these questions The study utilizes normal clinical procedures which should aid the transferability of the results
This multicentre randomized controlled clinical trial will be carried out in multimodal primary care clinics where both physiotherapists and chiropractors are consulted for musculoskeletal issues are selected to minimize selection bias from the patients pre-desired treatment modality
The subjects will be recruited among patients seeking care for persistent or recurrent Neck pain NP either self-selected or through referrals from general practitioners in the local areal The aim is to study the effect of SMT and stretching exercises compared to stretching exercises alone two well-known interventions for NP during a two-week treatment regimen
The primary outcome is the activity of the autonomic nervous system Heart Rate Variability HRV but also Conditioned Pain Modulation CPM will be measured HRV and CPM will be measured at baseline prior to the third treatment and after the fourth treatment
The subjective pain experience will be investigated by using two different instruments accessing pain intensity and the affective quality of pain asked at the assessments during the two weeks of treatment and 2 months after the period of intervention ends
Highly structured data collection procedures should provide reliable data to answer these questions The study utilizes normal clinical procedures which should aid the transferability of the results
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