Clinical trial NCT05240547: Chiropractic Spinal Manipulation for Headache
Official title: Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Tension-Type Headache
Lead sponsor: Real Centro Universitario Maria Cristina
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
measure: Pain frequency
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: 4 weeks
measure: Pressure pain thresholds
timeFrame: 4 weeks
Other outcomes:
measure: Sex
timeFrame: 4 months
measure: Age
timeFrame: 4 months
measure: Costs for care
timeFrame: 4 months
measure: Costs in stipends
timeFrame: 4 months
measure: Total number of potential participants recruited initially
timeFrame: 4 months
measure: Total number of potential participants who made contact showing an interest in the study
timeFrame: 4 months
measure: Total number of participants completing the study
timeFrame: 4 months
Locations:
city: San Lorenzo De El Escorial
country: Spain
facility: Real Centro Universitario María Cristina
state: Madrid
Study officials:
affiliation: RCU María Cristina
name: Carlos Gevers Montoro, DC, MSc
role: PRINCIPAL_INVESTIGATOR
References: