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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

Tracking Information
First Submitted Date  ICMJE June 20, 2018
First Posted Date  ICMJE July 3, 2018
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE January 4, 2019
Actual Primary Completion Date May 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
Change in Pain sensitivity [ Time Frame: 1 and 2 weeks ]
Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2018)
Change in Pain sensitivity [ Time Frame: 1 and 2 weeks ]
Pressure Pain Threshold is measuring pain sensitivity in a reliable and standardized manner using an algometer
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2018)
  • 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
  • Change in Disability [ Time Frame: 1 and 2 weeks ]
    Neck Disability Index (10 questions, answer options 1-6, summary score)
  • Common side-effects [ Time Frame: 1 week ]
    Question using text messages
Original Other Pre-specified Outcome Measures
 (submitted: June 23, 2018)
  • 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
  • Change in Disability [ Time Frame: 1 and 2 weeks ]
    Neck Disability Index (10 questions, answer options 1-6, summary score)
  • Common side-effects [ Time Frame: 1 week ]
    Question using text messages
  • Common side-effects [ Time Frame: 2 weeks ]
    Question using text messages
 
Descriptive Information
Brief Title  ICMJE Spinal Pain and Autonomic Responses to Chiropractic Care
Official Title  ICMJE The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • 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
  • Other: Stretching
    Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Study Arms  ICMJE
  • Experimental: Intervention
    Stretching and Spinal Manipulative Therapy
    Intervention: Other: Stretching and Spinal manipulative therapy
  • Active Comparator: Comparator
    Stretching
    Intervention: Other: Stretching
Publications * Galaasen Bakken A, Axén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2020)
123
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2018)
120
Actual Study Completion Date  ICMJE May 2, 2020
Actual Primary Completion Date May 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03576846
Other Study ID Numbers  ICMJE KIIMMIIRIA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Anonymized information may be shared with other researchers upon request, pending ethical approval.
Responsible Party Iben Axen, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE University of Southern Denmark
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP