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Completed

NCT Number: NCT03576846

Spinal Pain and Autonomic Responses to Chiropractic Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danvik Kiropraktik och Rehab, Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Stretching and Spinal manipulative therapy

Other

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

Stretching

Other

Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. 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.

  2. Change in Disability Score

    Time frame: 2 weeks

    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

  3. Common Side-effects

    Time frame: 1 week

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation

Acronym: SPARC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 3, 2018
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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