Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervicogenic Headache
- Sponsor
- Real Centro Universitario Maria Cristina
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pain frequency
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Pain frequency
Time Frame: 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)
Pain intensity
Time Frame: 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)
Secondary Outcomes
- Pain Catastrophizing Scale(4 weeks)
- Pressure pain thresholds(4 weeks)