Clinical trial NCT03576846: Spinal Pain and Autonomic Responses to Chiropractic Care
Official title: The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
spinal manipulative therapy
heart rate variability
conditioned pain modulation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2018-07-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into two arms: 1: stretching exercises only, 2: stretching exercises and Spinal Manipulative Therapy
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Heart Rate Variability
timeFrame: 1 and 2 weeks
Secondary outcomes:
measure: Change in Pain sensitivity
timeFrame: 1 and 2 weeks
Other outcomes:
measure: Change in Pain
timeFrame: 1 and 2 weeks, weekly for 12 weeks
measure: Change in Disability
timeFrame: 1 and 2 weeks
measure: Common side-effects
timeFrame: 1 week
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Stockholm
country: Sweden
facility: Danvik Kiropraktik och Rehab
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.