An interventional study of Spinal Manipulation and Placebo in Cervicogenic Headache and Tension-Type Headache, sponsored by Real Centro Universitario Maria Cristina. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Real Centro Universitario Maria Cristina · Not applicable, Interventional, and Treatment
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.
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.
192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →Real Centro Universitario Maria Cristina is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Spinal manipulative therapy will be delivered to the cervical spine (segments including occiput-atlas to C7-D1) according to the chiropractors' evaluation during each visit. During each session, one or two segments will be manipulated using a high-velocity low-amplitude thrust manipulation (a joint cavitation will be expected, if not, the thrust can repeated once) applied to the segments with the highest motion restriction, as determined by the chiropractor by static and motion palpation of the cervical spine.
Other: Spinal Manipulation
Sham manipulation will be delivered to the cervical spine (segments including occiput-atlas to C7-D1) according to the chiropractors' evaluation during each visit. During each session, one or two segments will receive a sham manipulation applied to the segments with the highest motion restriction, as determined by the chiropractor by static and motion palpation of the cervical spine. The sham manipulation will consist in a identical contact to the real manipulation, except the thrust will be delivered towards the table, away from the target segment and with the intention to lower the cervical drop piece of the table, which will substitute the joint cavitation noise.
Other: Placebo
Spinal manipulative therapy delivered to the cervical spine by a chiropractor
Sham manipulative treatment delivered to the cervical spine by a chiropractor
Pain intensity
Pain intensity will be measured by showing patients a numerical rating scale from 0 (no pain at all) to 10 (maximum possible pain)
Time frame: 4 weeks
Pain frequency
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)
Time frame: 4 weeks
Pain Catastrophizing Scale
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.
Time frame: 4 weeks
Pressure pain thresholds
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.
Time frame: 4 weeks
Sex
Biological sex (Male or Female) for feasibility purposes
Time frame: 4 months
Age
Age (measured in years) for feasibility purposes
Time frame: 4 months
Costs for care
The costs related to the time dedicated by researchers to the study will be calculated in Euros.
Time frame: 4 months
Costs in stipends
Costs per participant for care received will be calculated in Euros.
Time frame: 4 months
Total number of potential participants recruited initially
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).
Time frame: 4 months
Total number of potential participants who made contact showing an interest in the study
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).
Time frame: 4 months
Total number of participants completing the study
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.
Time frame: 4 months
Plan to share: No
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Real Centro Universitario Maria Cristina