Cervicogenic HeadacheNCT05240547
Chiropractic Spinal Manipulation for Headache
A study testing Spinal Manipulation in people with Cervicogenic Headache and Tension-Type Headache, run by Real Centro Universitario Maria Cristina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Cervicogenic Headache, Tension-Type Headache
- What is being tested?
- Spinal Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 14 Feb 2022to 14 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Real Centro Universitario María Cristina
El Escorial, Madrid, 28200
Carlos Gevers-Montoro, DC,MSc, +34-918909435, cgevers@rcumariacristina.com
About this study
Official title: Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study
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.
Read the 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.
- Conditions
- Cervicogenic Headache, Tension-Type Headache
- Being tested
- Spinal Manipulation, Placebo
- Medical subject headings
- Post-Traumatic Headache, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
Spinal manipulative therapy delivered to the cervical spine by a chiropractor
PlaceboOther
Sham manipulative treatment delivered to the cervical spine by a chiropractor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Spinal Manipulation |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start14 Feb 2022
- Primary completion30 May 2024 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Centro Universitario Maria Cristina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Gevers Montoro, DC, MSc, Principal investigator, RCU María Cristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240547
- Sponsor's protocol ID
- SMTHA
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Spinal Manipulation for Cervicogenic and Tension-type Headache: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT05240547
- Acronym / sponsor ID
- SMTHA
- Conditions
- Cervicogenic Headache, Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Real Centro Universitario Maria CristinaUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Experimental | Other: Spinal ManipulationSpinal 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. |
| Placebo | Placebo comparator | Other: PlaceboSham 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal ManipulationSpinal manipulative therapy delivered to the cervical spine by a chiropractor | Other | Spinal manipulation |
| PlaceboSham manipulative treatment delivered to the cervical spine by a chiropractor | Other | Placebo |
Primary outcome
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)
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)
2 secondary outcomes
Pain Catastrophizing Scale
Time frame: 4 weeks
Pressure pain thresholds
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gevers Montoro, DC, MSc principal investigator
RCU María Cristina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Cervicogenic Headache and Tension-Type Headache, run by Real Centro Universitario Maria Cristina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Torres Gonzalez, BSc (918909435, elisa.torres.quiro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.