Chronic HeadacheNCT02684916
Chiropractic Treatment for Headache Among Children Aged 7-14
A study testing Chiropractic treatment in people with Chronic Headache, run by Nordic Institute of Chiropractic and Clinical Biomechanics at 1 site in Denmark.
Trial summary
The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Chronic Headache
- What is being tested?
- Chiropractic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Oct 2019
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Headaches for at least half a year.
- Headache for at least 4 days pr. month.
- At least one musculoskeletal dysfunction as identified by an experienced chiropractor as a movement restriction in one or more of the spinal joints and painful on manual palpation suitable for chiropractic manipulation treatment at the time of the initial screening.
- Able to report information on headache via cell phone either by him- or herself or with help from the parents.
Who cannot join
- Contraindications for chiropractic treatment
- Ongoing treatment for headache at another practitioner, except medical treatment 3 months prior to inclusion.
- Lack of reporting baseline data via sms 4 weeks prior to inclusion.
- Acute neck or head trauma during the trial period which is estimated to influence the headache
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Chiropractic Manipulation Treatment Versus Placebo Manipulation on Children Aged 7-14 Years With Headache and Musculoskeletal Problems. A Randomized Clinical Trial
The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months.
Read the detailed description
The study is a two-armed parallel, randomized controlled clinical trial where children suffering from chronic headache and at the same time having one or more biomechanical dysfunctions of the spine are randomized to either chiropractic manipulation treatment or placebo manipulation treatment.
The outcome is based on weekly sms responses collecting the number of days with headache the past week, intensity of headache and use of medication for headache. These are answered four weeks prior to initiation of treatment and 16 weeks thereafter. After the 16 weeks follow-up, a final questionnaire is completed including information about the course and the present headache status.
The primary outcome is the number of days with headache. Secondary outcomes are intensity of headaches and use of medication for headache.
Covariates are collected via baseline questionnaires on patient demographics; medical history; factors known to initiate, worsen or ease the headache; prevalence of headache in the nearest family; and behavioral patterns known to influence headache.
- Conditions
- Chronic Headache
- Being tested
- Chiropractic treatment, Placebo
- Keywords
- Chiropractic spinal manipulation, Children, Pediatric, Headache
- Medical subject headings
- Headache Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic treatmentProcedure or surgery
The child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits.
The parents and the child are unaware of group allocation.
PlaceboProcedure or surgery
Non-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic treatment | Experimental | Visit with active treatment. Receives: Procedure: Chiropractic treatment |
| Placebo | Placebo comparator | Visit without active treatment. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.
Patient or parent reported via sms-service.
Measured: Assessed weekly for a period of four months.
Secondary outcomes (3)
Intensity of headache, graded on a 0-10 scale, where 10 is the worst, over four months analyzed as repeated measures with end-point at four months.
Patient or parent reported via sms-service.
Measured: Assessed weekly for a period of four months.
Use of medicine the past week due to headache over four months analyzed as repeated measures with end-point at four months.
Patient or parent reported via sms-service.
Measured: Assessed weekly for a period of four months.
Improvement on a seven point Likert scale (from 'totally recovered' to 'worse than ever') assessed at four months.
Patient or parent reported via sms-service.
Measured: Assessed at the end of four months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical Biomechanics
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Susanne L. Rosing, D.C., MSC, Principal investigator, Nordic Institute of Chiropractic and Clinical Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684916
- Sponsor's protocol ID
- 1504
- Status last verified
- Apr 2018
- First submitted
- 3 Feb 2016
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lynge S, Vach W, Dissing KB, Hestbaek L. Potential effect modifiers for treatment with chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years: development of and results from a secondary analysis of a randomised clinical trial. Chiropr Man Therap. 2023 Jul 11;31(1):20. doi: 10.1186/s12998-023-00492-2.
PubMed 37434189Dissing KB, Vach W, Lynge S, Christensen HW, Hestbaek L. Description of recurrent headaches in 7-14-year-old children: Baseline data from a randomized clinical trial on effectiveness of chiropractic spinal manipulation in children with recurrent headaches. Chiropr Man Therap. 2023 Jan 30;31(1):5. doi: 10.1186/s12998-023-00479-z.
PubMed 36717833Lynge S, Dissing KB, Vach W, Christensen HW, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years - a randomised clinical trial. Chiropr Man Therap. 2021 Jan 7;29(1):1. doi: 10.1186/s12998-020-00360-3.
PubMed 33413519Lynge S, Hartvigsen J, Christensen HW, Vach W, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7-14 years, Protocol for a randomized clinical trial. Chiropr Man Therap. 2019 Aug 23;27:40. doi: 10.1186/s12998-019-0262-y. eCollection 2019.
PubMed 31462990
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chiropractic Manipulation Treatment Versus Placebo Manipulation on Children Aged 7-14 Years With Headache and Musculoskeletal Problems. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02684916
- Acronym / sponsor ID
- 1504
- Conditions
- Chronic Headache
- Keywords
- Chiropractic spinal manipulation, Children, Pediatric, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical BiomechanicsUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 18 Feb 2016 (estimated)
- 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.
The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months.
Detailed description
The study is a two-armed parallel, randomized controlled clinical trial where children suffering from chronic headache and at the same time having one or more biomechanical dysfunctions of the spine are randomized to either chiropractic manipulation treatment or placebo manipulation treatment.
The outcome is based on weekly sms responses collecting the number of days with headache the past week, intensity of headache and use of medication for headache. These are answered four weeks prior to initiation of treatment and 16 weeks thereafter. After the 16 weeks follow-up, a final questionnaire is completed including information about the course and the present headache status.
The primary outcome is the number of days with headache. Secondary outcomes are intensity of headaches and use of medication for headache.
Covariates are collected via baseline questionnaires on patient demographics; medical history; factors known to initiate, worsen or ease the headache; prevalence of headache in the nearest family; and behavioral patterns known to influence headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic treatment | Experimental | Procedure: Chiropractic treatmentVisit with active treatment. |
| Placebo | Placebo comparator | Procedure: PlaceboVisit without active treatment. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Headaches for at least half a year.
- Headache for at least 4 days pr. month.
- At least one musculoskeletal dysfunction as identified by an experienced chiropractor as a movement restriction in one or more of the spinal joints and painful on manual palpation suitable for chiropractic manipulation treatment at the time of the initial screening.
- Able to report information on headache via cell phone either by him- or herself or with help from the parents.
Key exclusion criteria (4 listed)
- Contraindications for chiropractic treatment
- Ongoing treatment for headache at another practitioner, except medical treatment 3 months prior to inclusion.
- Lack of reporting baseline data via sms 4 weeks prior to inclusion.
- Acute neck or head trauma during the trial period which is estimated to influence the headache
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 |
|---|---|---|
| Chiropractic treatmentThe child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits. The parents and the child are unaware of group allocation. | Procedure or surgery | Chiropractic treatment |
| PlaceboNon-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well. | Procedure or surgery | Placebo |
Primary outcome
Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months.
Time frame: Assessed weekly for a period of four months.
Patient or parent reported via sms-service.
3 secondary outcomes
Intensity of headache, graded on a 0-10 scale, where 10 is the worst, over four months analyzed as repeated measures with end-point at four months.
Time frame: Assessed weekly for a period of four months.
Use of medicine the past week due to headache over four months analyzed as repeated measures with end-point at four months.
Time frame: Assessed weekly for a period of four months.
Improvement on a seven point Likert scale (from 'totally recovered' to 'worse than ever') assessed at four months.
Time frame: Assessed at the end of four months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Derived from this study: PubMed 37434189Lynge S, Vach W, Dissing KB, Hestbaek L. Potential effect modifiers for treatment with chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years: development of and results from a secondary analysis of a randomised clinical trial. Chiropr Man Therap. 2023 Jul 11;31(1):20. doi: 10.1186/s12998-023-00492-2.
- Derived from this study: PubMed 36717833Dissing KB, Vach W, Lynge S, Christensen HW, Hestbaek L. Description of recurrent headaches in 7-14-year-old children: Baseline data from a randomized clinical trial on effectiveness of chiropractic spinal manipulation in children with recurrent headaches. Chiropr Man Therap. 2023 Jan 30;31(1):5. doi: 10.1186/s12998-023-00479-z.
- Derived from this study: PubMed 33413519Lynge S, Dissing KB, Vach W, Christensen HW, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years - a randomised clinical trial. Chiropr Man Therap. 2021 Jan 7;29(1):1. doi: 10.1186/s12998-020-00360-3.
- Derived from this study: PubMed 31462990Lynge S, Hartvigsen J, Christensen HW, Vach W, Hestbaek L. Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7-14 years, Protocol for a randomized clinical trial. Chiropr Man Therap. 2019 Aug 23;27:40. doi: 10.1186/s12998-019-0262-y. eCollection 2019.
- 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.
Susanne L. Rosing, D.C., MSC principal investigator
Nordic Institute of Chiropractic and Clinical Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic treatment in people with Chronic Headache, run by Nordic Institute of Chiropractic and Clinical Biomechanics at 1 site in Denmark.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Mar 2020. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months. (time frame: Assessed weekly for a period of four months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684916, which also lists 4 linked publications.
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 9 Mar 2020.