Chiropractic Spinal Manipulation for Headache

Tension-Type Headache Clinical Trial

Official title:

Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240547
• Other study ID #: SMTHA
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: December 14, 2024

Study information

• Verified date: November 2023
• Source: Real Centro Universitario Maria Cristina
• Contact: Elisa Torres Gonzalez, BSc
• Phone: 918909435
• Email: elisa.torres.quiro[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 14, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache
• Tension-Type Headache

Intervention

Other:
• Spinal Manipulation
Spinal manipulative therapy delivered to the cervical spine by a chiropractor
• Placebo
Sham manipulative treatment delivered to the cervical spine by a chiropractor

Locations

Country	Name	City	State
Spain	Real Centro Universitario María Cristina	San Lorenzo De El Escorial	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Real Centro Universitario Maria Cristina

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex	Biological sex (Male or Female) for feasibility purposes	4 months
Other	Age	Age (measured in years) for feasibility purposes	4 months
Other	Costs for care	The costs related to the time dedicated by researchers to the study will be calculated in Euros.	4 months
Other	Costs in stipends	Costs per participant for care received will be calculated in Euros.	4 months
Other	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
Other	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
Other	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
Primary	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
Primary	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
Secondary	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
Secondary	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