Back to resultsChiropractic Spinal Manipulation for Headache
Primary Purpose
Cervicogenic Headache, Tension-Type Headache
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spinal Manipulation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache
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
Sites / Locations
- Real Centro Universitario María CristinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Spinal manipulation
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05240547
First Posted
February 1, 2022
Last Updated
March 27, 2023
Sponsor
Real Centro Universitario Maria Cristina
1. Study Identification
Unique Protocol Identification Number
NCT05240547
Brief Title
Chiropractic Spinal Manipulation for Headache
Official Title
Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Centro Universitario Maria Cristina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache, Tension-Type Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Intervention Description
Spinal manipulative therapy delivered to the cervical spine by a chiropractor
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sham manipulative treatment delivered to the cervical spine by a chiropractor
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Title
Pain frequency
Description
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
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale
Description
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
Title
Pressure pain thresholds
Description
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
Other Pre-specified Outcome Measures:
Title
Sex
Description
Biological sex (Male or Female) for feasibility purposes
Time Frame
4 months
Title
Age
Description
Age (measured in years) for feasibility purposes
Time Frame
4 months
Title
Costs for care
Description
The costs related to the time dedicated by researchers to the study will be calculated in Euros.
Time Frame
4 months
Title
Costs in stipends
Description
Costs per participant for care received will be calculated in Euros.
Time Frame
4 months
Title
Total number of potential participants recruited initially
Description
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
Title
Total number of potential participants who made contact showing an interest in the study
Description
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
Title
Total number of participants completing the study
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa Torres Gonzalez, BSc
Phone
918909435
Email
elisa.torres.quiro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gevers Montoro, DC, MSc
Organizational Affiliation
RCU María Cristina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Real Centro Universitario María Cristina
City
San Lorenzo De El Escorial
State/Province
Madrid
ZIP/Postal Code
28200
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Gevers-Montoro, DC,MSc
Phone
+34-918909435
Email
cgevers@rcumariacristina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chiropractic Spinal Manipulation for Headache
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