Neck Pain Clinical Trial
Official title:
The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation
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.
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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