Cervicogenic Headache, Tension-Type Headache
Conditions
Brief summary
This is a pilot and feasibility randomized controlled trial to assess the efficacy of chiropractic spinal manipulative therapy in patients with tension-type and cervicogenic headache.
Detailed description
This study is a pilot and feasibility randomized controlled trial that aims to assess the efficacy of 8 treatment sessions of chiropractic spinal manipulative therapy compared to the same number of sham manipulative therapy or placebo interventions for chronic cervicogenic and tension-type headache. The hypothesis proposed is that chiropractic care will reduce the intensity and frequency of both cervicogenic and tension-type headache episodes, when compared to placebo. A sample of 20 participants suffering from cervicogenic or tension-type headache for at least 3 months, aged 18 to 67 will be randomized to receive either 8 sessions of spinal manipulative treatment (2 times per week for a total of 4 weeks) or 8 sessions of a validated sham spinal manipulation. Outcomes will be assessed at baseline, after 4 treatments and at the end of the treatment period.
Interventions
OTHERSpinal Manipulation
Spinal manipulative therapy delivered to the cervical spine by a chiropractor
OTHERPlacebo
Sham manipulative treatment delivered to the cervical spine by a chiropractor
Sponsors
Real Centro Universitario Maria Cristina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
Inclusion criteria
* At least 2 episodes per month of cervicogenic or tension-type headache for at least 3 months. Diagnoses will be determined by case history and physical examination according to the International Headache Society criteria (3rd Edition)
Exclusion criteria
* Not fulfilling the inclusion criteria * Having received chiropractic treatment in the previous 12 months * Diagnosis or frequent symptoms of migraine headaches (symptoms present at least once a month) without an overlapping presentation of cervicogenic or tension-type headache. * Patients with pathologies affecting the nervous system (MS, tumors, past history of stroke...) * Contraindications to manual therapy, particularly spinal manipulative therapy (cancer, uncontrolled high blood-pressure, severe cardiovascular conditions) * Past history of cervical spine surgery * Pregnancy * Having being diagnosed with a psychiatric conditions, with the exception of depression and anxiety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 4 weeks | Pain intensity will be measured by showing patients a numerical rating scale from 0 (no pain at all) to 10 (maximum possible pain) |
| Pain frequency | 4 weeks | Chronic pain patients will describe whether their pain is episodic (pain-free periods of at least 4 week duration) or fluctuating (no pain-free periods of at least 4 week duration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale | 4 weeks | The Pain Catastrophizing Scale (PCS) provides the level of catastrophizing beliefs and emotions that a person has with regards to his/her own pain experience, in this case, low back pain. It includes 13 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-52, where 0 is the lowest possible level of catastrophizing and 52 the highest. |
| Pressure pain thresholds | 4 weeks | Pressure pain thresholds (PPTs) are part of quantitative sensory testing. The aim is to identify the threshold and the sensitivity to suprathreshold pressure stimulation in different areas of the patients' bodies. An algometer will be used (Wagner Force Dial FDK20, Greenwich, CT, USA) to measure PPTs in the suboccipital muscles for each patient. The measure will be taken before and after treatment to determine the immediate effects of spinal manipulative therapy on pain sensitivity. this will be used to correlate with the changes in clinical pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total number of potential participants recruited initially | 4 months | The total number of participants recruited at the beginning of the study will be recorded as an outcome in order to calculate Drop-out ratios (dividing the number of participants completing the study by the total number of initially recruited). |
| Sex | 4 months | Biological sex (Male or Female) for feasibility purposes |
| Total number of participants completing the study | 4 months | The number of participants recruited and completing the study will be recorded as an outcome to be later divided by the number of months of the study, in order to calculate the recruitment rate. |
| Total number of potential participants who made contact showing an interest in the study | 4 months | The total number of potential participants interested in the study will be recorded as an outcome in order to calculate Recruitment ratio (dividing the number of participants initiating the study by the total number of interested). |
| Age | 4 months | Age (measured in years) for feasibility purposes |
| Costs for care | 4 months | The costs related to the time dedicated by researchers to the study will be calculated in Euros. |
| Costs in stipends | 4 months | Costs per participant for care received will be calculated in Euros. |
Countries
Spain
Contacts
Primary ContactElisa Torres Gonzalez, BSc
Outcome results
None listed