See the published version of this preprint at Chiropractic & Manual Therapies.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Research
Lise Hestbaek
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1620-4556
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.
Methods Design: A two-arm, single-blind, superiority randomised controlled trial.
Setting: One chiropractic clinic and one paediatric specialty practice in Denmark
Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified.
Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.
Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.
Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR=2.8 (95% CI: 1.5-5.3), NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.
Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.
Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.
Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916
Keywords
Ηeadache, chiropractic, children, manipulation, adolescents, effectiveness, clinical trial
Figure 1
Figure 1
Figure 2
Figure 2
Figure 3
Figure 3
Figure 4
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
- AdditionalFile1IODAreport.pdf
Additional File 1, IODA report.pdf. The results of the initial outcome data analysis and the resulting decision report.
- AdditionalFile1IODAreport.pdf
Additional File 1, IODA report.pdf. The results of the initial outcome data analysis and the resulting decision report.
- AdditionalFile2imputation.pdf
Additional File 2, imputation.pdf. Tables showing results following imputation of data.
- AdditionalFile2imputation.pdf
Additional File 2, imputation.pdf. Tables showing results following imputation of data.
- AdditionalFile3CONSORT2010Checklist.pdf
Additional File 3, CONSORT 2010 Checklist.pdf. Full reporting check list including page numbers.
- AdditionalFile3CONSORT2010Checklist.pdf
Additional File 3, CONSORT 2010 Checklist.pdf. Full reporting check list including page numbers.
- AdditionalFile4missingsms.jpg
Additional File 4, missing sms.jpg. Flowchart of SMS-reports.
- AdditionalFile4missingsms.jpg
Additional File 4, missing sms.jpg. Flowchart of SMS-reports.
- AdditionalFile5Tables.pdf
Additional File 5, Tables.pdf. Additional information in tables.
- AdditionalFile5Tables.pdf
Additional File 5, Tables.pdf. Additional information in tables.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Chiropractic & Manual Therapies.
No community comments so far
Editorial decision: Accept
On 10 Dec, 2020
Editor assigned
On 18 Nov, 2020
Submission checks complete
On 18 Nov, 2020
Editor invited
On 18 Nov, 2020
Version 2
Posted 11 Nov, 2020
No comments provided
Editorial decision: Minor Revision
On 03 Nov, 2020
Reviewer #2 agreed
On 02 Nov, 2020
Reviewer #1 agreed
On 02 Nov, 2020
Review #1 received
Received 02 Nov, 2020
Review #2 received
Received 02 Nov, 2020
Reviewers invited
Invitations sent on 01 Nov, 2020
Editor assigned
On 29 Oct, 2020
Submission checks complete
On 29 Oct, 2020
Editor invited
On 29 Oct, 2020
No comments provided
Editorial decision: Major Revision
On 30 Sep, 2020
Review #2 received
Received 29 Sep, 2020
Reviewer #2 agreed
On 15 Sep, 2020
Review #1 received
Received 28 Aug, 2020
Reviewers invited
Invitations sent on 27 Aug, 2020
Reviewer #1 agreed
On 27 Aug, 2020
Editor assigned
On 13 Aug, 2020
Submission checks complete
On 13 Aug, 2020
Editor invited
On 12 Aug, 2020
First submitted
On 10 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Physical Medicine & Rehab
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Chiropractic & Manual Therapies.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Lise Hestbaek
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1620-4556
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Chiropractic & Manual Therapies.
No community comments so far
Editorial decision: Accept
On 10 Dec, 2020
Editor assigned
On 18 Nov, 2020
Submission checks complete
On 18 Nov, 2020
Editor invited
On 18 Nov, 2020
Version 2
Posted 11 Nov, 2020
No comments provided
Editorial decision: Minor Revision
On 03 Nov, 2020
Reviewer #2 agreed
On 02 Nov, 2020
Reviewer #1 agreed
On 02 Nov, 2020
Review #1 received
Received 02 Nov, 2020
Review #2 received
Received 02 Nov, 2020
Reviewers invited
Invitations sent on 01 Nov, 2020
Editor assigned
On 29 Oct, 2020
Submission checks complete
On 29 Oct, 2020
Editor invited
On 29 Oct, 2020
No comments provided
Editorial decision: Major Revision
On 30 Sep, 2020
Review #2 received
Received 29 Sep, 2020
Reviewer #2 agreed
On 15 Sep, 2020
Review #1 received
Received 28 Aug, 2020
Reviewers invited
Invitations sent on 27 Aug, 2020
Reviewer #1 agreed
On 27 Aug, 2020
Editor assigned
On 13 Aug, 2020
Submission checks complete
On 13 Aug, 2020
Editor invited
On 12 Aug, 2020
First submitted
On 10 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Physical Medicine & Rehab
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Chiropractic & Manual Therapies.
Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches.
Methods Design: A two-arm, single-blind, superiority randomised controlled trial.
Setting: One chiropractic clinic and one paediatric specialty practice in Denmark
Participants: 199 children aged 7 to 14 years, who experienced at least one episode of headache per week for the previous 6 months and with at least one musculoskeletal dysfunction identified.
Interventions: All participants and parents received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group, and the children in the control group received approximately eight visits during the treatment period.
Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account.
Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p=0.019, NNT=7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR=2.8 (95% CI: 1.5-5.3), NNT=5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use.
Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches.
Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches.
Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT02684916
Figure 1
Figure 1
Figure 2
Figure 2
Figure 3
Figure 3
Figure 4
Figure 4
This is a list of supplementary files associated with this preprint. Click to download.
- AdditionalFile1IODAreport.pdf
Additional File 1, IODA report.pdf. The results of the initial outcome data analysis and the resulting decision report.
- AdditionalFile1IODAreport.pdf
Additional File 1, IODA report.pdf. The results of the initial outcome data analysis and the resulting decision report.
- AdditionalFile2imputation.pdf
Additional File 2, imputation.pdf. Tables showing results following imputation of data.
- AdditionalFile2imputation.pdf
Additional File 2, imputation.pdf. Tables showing results following imputation of data.
- AdditionalFile3CONSORT2010Checklist.pdf
Additional File 3, CONSORT 2010 Checklist.pdf. Full reporting check list including page numbers.
- AdditionalFile3CONSORT2010Checklist.pdf
Additional File 3, CONSORT 2010 Checklist.pdf. Full reporting check list including page numbers.
- AdditionalFile4missingsms.jpg
Additional File 4, missing sms.jpg. Flowchart of SMS-reports.
- AdditionalFile4missingsms.jpg
Additional File 4, missing sms.jpg. Flowchart of SMS-reports.
- AdditionalFile5Tables.pdf
Additional File 5, Tables.pdf. Additional information in tables.
- AdditionalFile5Tables.pdf
Additional File 5, Tables.pdf. Additional information in tables.
Loading...