Spinal Pain and Autonomic Responses to Chiropractic Care (SPARC)
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|ClinicalTrials.gov Identifier: NCT03576846|
Recruitment Status : Completed
First Posted : July 3, 2018
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain||Other: Stretching and Spinal manipulative therapy Other: Stretching||Not Applicable|
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 incoming/ascending pain signals and/or the excitability of the central pain regulating mechanisms. People with chronic neck/shoulder 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 patient's 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized into two arms: 1: stretching exercises only, 2: stretching exercises and Spinal Manipulative Therapy|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The subject will not know the content of the other arm. The care provider cannot be blinded, as he/she will be performing the treatment. The investigator performing the measurements will not be aware of the treatment allocation, and the analyses will be masked for group allocation|
|Official Title:||The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation|
|Actual Study Start Date :||January 4, 2019|
|Actual Primary Completion Date :||May 2, 2020|
|Actual Study Completion Date :||May 2, 2020|
Stretching and Spinal Manipulative Therapy
Other: Stretching and Spinal manipulative therapy
Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy
Active Comparator: Comparator
Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
- Change in Heart Rate Variability [ Time Frame: 1 and 2 weeks ]The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm.
- Change in Pain sensitivity [ Time Frame: 1 and 2 weeks ]Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test.
- Change in Pain [ Time Frame: 1 and 2 weeks, weekly for 12 weeks ]Self-reported, using the Numeric Rating Scale (0-10) and McGills pain questionnaire
- Change in Disability [ Time Frame: 1 and 2 weeks ]Neck Disability Index (10 questions, answer options 1-6, summary score)
- Common side-effects [ Time Frame: 1 week ]Question using text messages
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576846
|Stockholm, Sweden, 171 77|
|Danvik Kiropraktik och Rehab|