Spinal Pain and Autonomic Responses to Chiropractic Care

NCT03576846 | Completed Results

• 1 other identifier: KIIMMIIRIA
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain

Keywords

neck pain; spinal manipulative therapy; heart rate variability; conditioned pain modulation

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability

  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 Outcomes (1)

• Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions .

  The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores

Other Outcomes (3)

• Change in Pain Intensity

  2 weeks, pain intensity is assessed at Baseline and after 2 weeks, the outcome is the difference between them.

• Change in Disability Score

  2 weeks

• Common Side-effects

  1 week

Study Arms (2)

Intervention

EXPERIMENTAL

Stretching and Spinal Manipulative Therapy

Other: Stretching and Spinal manipulative therapy

Comparator

ACTIVE COMPARATOR

Stretching

Other: Stretching

Interventions

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

Intervention

Stretching OTHER

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

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern Denmark: collaborator
• Karolinska Institutet: lead

Study Sites (2)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

Danvik Kiropraktik och Rehab

Stockholm, Sweden

Location

Related Publications (5)

• 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.

  PMID: 40217263 DERIVED

• 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.

  PMID: 36192738 DERIVED

• 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.

  PMID: 34844625 DERIVED

• 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.

  PMID: 34706706 DERIVED

• 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.

  PMID: 31606042 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ass professor Iben Axén
• Organization: Karolinska Institutet

iben.axen@ki.se

+46704400618

Study Officials

• Iben Axén

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will be randomized into two arms: 1: stretching exercises only, 2: stretching exercises and Spinal Manipulative Therapy

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 3, 2018
• Study Start: January 4, 2019
• Primary Completion: May 2, 2020
• Study Completion: May 2, 2020
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)