Neck Pain Clinical Trial
— SPARCOfficial title:
The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation
NCT number | NCT03576846 |
Other study ID # | KIIMMIIRIA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 4, 2019 |
Est. completion date | May 2, 2020 |
Verified date | September 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Sweden | Danvik Kiropraktik och Rehab | Stockholm | |
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | University of Southern Denmark |
Sweden,
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 |
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