Spinal Pain and Autonomic Responses to Chiropractic Care (SPARC)
The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden, 171 77
- Karolinska Institutet
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Stockholm, Sweden
- Danvik Kiropraktik och Rehab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- minimum 18 years,
- able to read and understand Swedish,
- persistent or recurrent Neck Pain (duration of current episode more than 6 months and at least one previous episode of NP),
- no chiropractic treatment during the previous 3 months.
Exclusion Criteria:
- conditions or medications that will affect the Heart Rate Variability measurements (cardiovascular disease, diabetes, pregnancy, obesity, currently using pain-reducing medication, steroids or antidepressants),
- all contraindications to manual treatment, (anything that could seriously aggravate the pain (such as inflammatory conditions) or signal cerebrovascular injuries (previous drop attacks or a recent episode of new headache or dizziness).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Stretching and Spinal Manipulative Therapy
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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
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|
Active Comparator: Comparator
Stretching
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Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart Rate Variability
Time Frame: 2 weeks, the change is reported between baseline-2 weeks
|
The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm.
It is measured as the time between two R-waves on the ECG and measured in ms.
|
2 weeks, the change is reported between baseline-2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions .
Time Frame: The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores
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Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test.
Pain is rated on the Numeric Rating Scale, ranging from 10 (unbearable pain) to 0 (no pain).
The outcome is the difference between these two measurements.
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The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity
Time Frame: 2 weeks, pain intensity is assessed at Baseline and after 2 weeks, the outcome is the difference between them.
|
Self-reported, using the Numeric Rating Scale (0-10).
High scores indicate more severe pain.
The outcome is the difference between the scores measured at baseline at at two weeks.
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2 weeks, pain intensity is assessed at Baseline and after 2 weeks, the outcome is the difference between them.
|
|
Change in Disability Score
Time Frame: 2 weeks
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Neck Disability Index (10 questions, answer options 1-6, summary score, higher score indicating higher disabiity), reported at baseline and at 2 weeks follow up.
The measure is the difference between these two scores
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2 weeks
|
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Common Side-effects
Time Frame: 1 week
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Description and count of common side effects, data collected through a single question using text messages. Thus, the participants described their side-effects, which were categorized and counted. |
1 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Iben Axén, Karolinska Institutet
Publications and helpful links
General Publications
- Galaasen Bakken A, Eklund A, Oksanen A, Axen I. The response to individualized treatment after a standardized treatment protocol among neck pain sufferers: a secondary analysis of a randomized controlled trial. Chiropr Man Therap. 2025 Apr 11;33(1):13. doi: 10.1186/s12998-025-00579-y.
- Bakken AG, Eklund A, Warnqvist A, O'Neill S, Hallman DM, Axen I. Are changes in pain associated with changes in heart rate variability in patients treated for recurrent or persistent neck pain? BMC Musculoskelet Disord. 2022 Oct 4;23(1):895. doi: 10.1186/s12891-022-05842-4.
- Galaasen Bakken A, Eklund A, Hallman DM, Axen I. The effect of spinal manipulative therapy and home stretching exercises on heart rate variability in patients with persistent or recurrent neck pain: a randomized controlled trial. Chiropr Man Therap. 2021 Nov 29;29(1):48. doi: 10.1186/s12998-021-00406-0.
- Bakken AG, Eklund A, Warnqvist A, O'Neill S, Axen I. The effect of two weeks of spinal manipulative therapy and home stretching exercises on pain and disability in patients with persistent or recurrent neck pain; a randomized controlled trial. BMC Musculoskelet Disord. 2021 Oct 27;22(1):903. doi: 10.1186/s12891-021-04772-x.
- Galaasen Bakken A, Axen I, Eklund A, O'Neill S. The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial. Trials. 2019 Oct 12;20(1):590. doi: 10.1186/s13063-019-3678-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIIMMIIRIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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