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Spinal Pain and Autonomic Responses to Chiropractic Care

NCT ID: NCT03576846

Last Updated: 2025-12-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2020-05-02

Brief Summary

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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

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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.

Conditions

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Neck Pain

Keywords

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neck pain spinal manipulative therapy heart rate variability conditioned pain modulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized into two arms: 1: stretching exercises only, 2: stretching exercises and Spinal Manipulative Therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Study Groups

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Intervention

Stretching and Spinal Manipulative Therapy

Group Type EXPERIMENTAL

Stretching and Spinal manipulative therapy

Intervention Type 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

Comparator

Stretching

Group Type ACTIVE_COMPARATOR

Stretching

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Stretching

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Iben Axen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iben Axén

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Danvik Kiropraktik och Rehab

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 40217263 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36192738 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34844625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34706706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31606042 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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KIIMMIIRIA

Identifier Type: -

Identifier Source: org_study_id