Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7–14 years, Protocol for a randomized clinical trial

Abstract

Background Headache is one of the most common pain symptoms in childhood having a negative impact on many aspects of the lives of affected children, both short-term and long-term. Therefore, it is important to document safe and effective treatment options. Chiropractic spinal manipulation is a commonly used treatment option for these patients, although there are no randomized clinical trials documenting the effectiveness of this in pediatric headache. However, there is moderate evidence for effectiveness of spinal manipulation for adults with tension-type and cervicogenic headaches. This paper describes the protocol for a two-armed randomized superiority clinical trial aiming to investigate the effectiveness of chiropractic manipulation versus sham manipulation in the treatment of recurrent headache in children aged 7–14. Methods Children with weekly headaches for at least six months will be included if they have indications for chiropractic manipulation. The participants will be randomized to either chiropractic manipulation or sham manipulation. Both children and parents will be blinded for allocation. There will be 100 children in each arm and they will answer weekly text messages four weeks prior to treatment and during a four months treatment period. Potential primary outcomes are weekly number of headaches, intensity of headache, medication use and global perceived effect. Secondary outcomes include side-effects and headache status after one year. An initial outcome data analysis will be performed to inform the choice of primary outcome (adaptive design). Intervention effects will be reported as the difference in mean values between the two treatment arms, Cohen’s effect size and numbers needed to treat. Discussion A major strength of this study is its pragmatic nature, where the active treatment group receives chiropractic manipulation according to their individual needs, while both groups continue their use of medication for headache according to their pre-trial habits. Other strengths include an elaborate sham procedure and the weekly outcome reports, reducing recall bias. If it is possible to develop effective treatment for headache in children, a life course of recurring problems may be altered with potential positive implications for both individuals and society. Trial registration ClinicalTrials.gov , identifier NCT02684916 . Electronic supplementary material The online version of this article (10.1186/s12998-019-0262-y) contains supplementary material, which is available to authorized users.

Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

“…A high-velocity, low-amplitude thrust, resulting in an audible cavitation, was given to improve the function of the joint. The treatment has been described in detail in the study protocol (25). All treatments were modi ed to t the age and size of the child as well as individual spinal characteristics.…”

“…A sample size calculation was conducted when the data collection was completed for 50 children in each treatment group (29). This was based on weekly headache days, and details were reported in the study protocol (25). A sample size of 100 children in each group was indicated to detect a difference of 20% in mean change score between groups with a power of 80% and a signi cance level of 5%.…”

Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

“…A sample size calculation was conducted when the data collection was completed for 50 children in each treatment group (29). This was based on weekly headache days, and details were reported in the study protocol (25). A sample size of 100 children in each group was indicated to detect a difference of 20% with a power of 80% and a signi cance level of 5%.…”

Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

“…This was a two-arm randomised superiority single-blinded clinical trial. The protocol of the study has been published elsewhere (25).…”

“…A sample size calculation was conducted when the data collection was completed for 50 children in each treatment group (29). This was based on weekly headache days, and details were reported in the study protocol (25). A sample size of 100 children in each group was indicated to detect a difference of 20%…”