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Spinal Pain and Autonomic Responses to Chiropractic Care (SPARC)

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ClinicalTrials.gov Identifier: NCT03576846
Recruitment Status : Completed
First Posted : July 3, 2018
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Iben Axen, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Neck Pain Other: Stretching and Spinal manipulative therapy Other: Stretching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into two arms: 1: stretching exercises only, 2: stretching exercises and Spinal Manipulative Therapy
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : May 2, 2020
Actual Study Completion Date : May 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Stretching and Spinal Manipulative Therapy
Other: 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

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




Primary Outcome Measures :
  1. Change in Heart Rate Variability [ Time Frame: 1 and 2 weeks ]
    The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm.


Secondary Outcome Measures :
  1. Change in Pain sensitivity [ Time Frame: 1 and 2 weeks ]
    Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test.


Other Outcome Measures:
  1. Change in Pain [ Time Frame: 1 and 2 weeks, weekly for 12 weeks ]
    Self-reported, using the Numeric Rating Scale (0-10) and McGills pain questionnaire

  2. Change in Disability [ Time Frame: 1 and 2 weeks ]
    Neck Disability Index (10 questions, answer options 1-6, summary score)

  3. Common side-effects [ Time Frame: 1 week ]
    Question using text messages



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576846


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 171 77
Danvik Kiropraktik och Rehab
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
University of Southern Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iben Axen, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03576846    
Other Study ID Numbers: KIIMMIIRIA
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized information may be shared with other researchers upon request, pending ethical approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iben Axen, Karolinska Institutet:
neck pain
spinal manipulative therapy
heart rate variability
conditioned pain modulation
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations