Neck Pain
Conditions
Keywords
neck pain, spinal manipulative therapy, heart rate variability, 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.
Interventions
OTHERStretching 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
OTHERStretching
Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
Sponsors
University of Southern Denmark
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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
Intervention model description
Subjects will be randomized into two arms: 1: stretching exercises only, 2: stretching exercises and Spinal Manipulative Therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability | 2 weeks, the change is reported between baseline-2 weeks | The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm. It is measured as the time between two R-waves on the ECG and measured in ms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions . | The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores | Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test. Pain is rated on the Numeric Rating Scale, ranging from 10 (unbearable pain) to 0 (no pain). The outcome is the difference between these two measurements. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | 2 weeks, pain intensity is assessed at Baseline and after 2 weeks, the outcome is the difference between them. | Self-reported, using the Numeric Rating Scale (0-10). High scores indicate more severe pain. The outcome is the difference between the scores measured at baseline at at two weeks. |
| Change in Disability Score | 2 weeks | Neck Disability Index (10 questions, answer options 1-6, summary score, higher score indicating higher disabiity), reported at baseline and at 2 weeks follow up. The measure is the difference between these two scores |
| Common Side-effects | 1 week | Description and count of common side effects, data collected through a single question using text messages. Thus, the participants described their side-effects, which were categorized and counted. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Stretching and Spinal Manipulative Therapy
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 | 66 |
| Comparator Stretching
Stretching: Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. | 65 |
| Total | 131 |
Baseline characteristics
| Characteristic | Intervention | Comparator | Total |
|---|---|---|---|
| Age, Continuous | 57 Years STANDARD_DEVIATION 14 | 57.5 Years STANDARD_DEVIATION 36 | 57.2 Years STANDARD_DEVIATION 13.8 |
| Heart rate variability | 27 ms STANDARD_DEVIATION 29 | 29 ms STANDARD_DEVIATION 21 | 28 ms STANDARD_DEVIATION 25 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 37 Participants | 36 Participants | 73 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 65 |
| other Total, other adverse events | 3 / 66 | 1 / 65 |
| serious Total, serious adverse events | 0 / 66 | 0 / 65 |
Outcome results
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. It is measured as the time between two R-waves on the ECG and measured in ms.
Time frame: 2 weeks, the change is reported between baseline-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Heart Rate Variability | 843 ms | Standard Deviation 129 |
| Comparator | Change in Heart Rate Variability | 887 ms | Standard Deviation 138 |
Secondary
Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions .
Conditioned Pain Modulation is assessed using a thumb clamp and a cold pressor test. Pain is rated on the Numeric Rating Scale, ranging from 10 (unbearable pain) to 0 (no pain). The outcome is the difference between these two measurements.
Time frame: The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores
Population: In this analysis, the original study arms were not used, and the participants were treated as one cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions . | -3.3 NRS change score | Standard Deviation 0.2 |
| Comparator | Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions . | 0.2 NRS change score | Standard Deviation 0.2 |
Other Pre-specified
Change in Disability Score
Neck Disability Index (10 questions, answer options 1-6, summary score, higher score indicating higher disabiity), reported at baseline and at 2 weeks follow up. The measure is the difference between these two scores
Time frame: 2 weeks
Population: The disability score is based on the instrument Neck Disability Index, and the change is the difference between the last and first measurement, 2 weeks apart
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Disability Score | -2.1 score on a scale | Standard Deviation 4.58 |
| Comparator | Change in Disability Score | -1.9 score on a scale | Standard Deviation 4.21 |
Other Pre-specified
Change in Pain Intensity
Self-reported, using the Numeric Rating Scale (0-10). High scores indicate more severe pain. The outcome is the difference between the scores measured at baseline at at two weeks.
Time frame: 2 weeks, pain intensity is assessed at Baseline and after 2 weeks, the outcome is the difference between them.
Population: This is an intention-to-treat analysis. Participants are analyzed according to the arm in which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Pain Intensity | 1.1 score on a scale | Standard Deviation 2.085 |
| Comparator | Change in Pain Intensity | 1.1 score on a scale | Standard Deviation 2.101 |
Other Pre-specified
Common Side-effects
Description and count of common side effects, data collected through a single question using text messages. Thus, the participants described their side-effects, which were categorized and counted.
Time frame: 1 week
Population: Description and count of side-effects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Common Side-effects | 3 Participants |
| Comparator | Common Side-effects | 1 Participants |