Spinal Pain and Autonomic Responses to Chiropractic Care

Neck Pain Clinical Trial

— SPARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576846
• Other study ID #: KIIMMIIRIA
• Status: Completed
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: May 2, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 2, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neck Pain

Intervention

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

Locations

Country	Name	City	State
Sweden	Danvik Kiropraktik och Rehab	Stockholm
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	University of Southern Denmark

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Pain	Self-reported, using the Numeric Rating Scale (0-10) and McGills pain questionnaire	1 and 2 weeks, weekly for 12 weeks
Other	Change in Disability	Neck Disability Index (10 questions, answer options 1-6, summary score)	1 and 2 weeks
Other	Common side-effects	Question using text messages	1 week
Primary	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.	1 and 2 weeks
Secondary	Change in Pain sensitivity	Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test.	1 and 2 weeks