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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal manipulation | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Manipulation | Other | Spinal manipulative therapy delivered to the cervical spine by a chiropractor |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sex | Biological sex (Male or Female) for feasibility purposes | 4 months |
| Age | Age (measured in years) for feasibility purposes | 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Torres Gonzalez, BSc | Contact | 918909435 | elisa.torres.quiro@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Gevers Montoro, DC, MSc | RCU MarÃa Cristina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Real Centro Universitario MarÃa Cristina | Recruiting | El Escorial | Madrid | 28200 | Spain |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Placebo | Other | Sham manipulative treatment delivered to the cervical spine by a chiropractor |
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| 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. | 4 weeks |
| Costs for care | The costs related to the time dedicated by researchers to the study will be calculated in Euros. | 4 months |
| Costs in stipends | Costs per participant for care received will be calculated in Euros. | 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). | 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). | 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. | 4 months |
| D009422 | Nervous System Diseases |
| D051270 | Headache Disorders, Primary |