Chiropractic Care on Behavior, Neurological Function and Quality of Life in ADHD Children - A Pilot Study

NCT ID: NCT03849807

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-02

Study Completion Date

2019-06-01

Brief Summary

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To date the effects of chiropractic care on behavior and neurological function in children diagnosed with ADHD has not been investigated thoroughly and is limited mostly to case studies and retrospective case reviews. Our research group recently completed a pilot study that investigated the effects of a single session of chiropractic care on oculomotor function and reading ability in children with ADHD. The findings of this study suggested that chiropractic care may have a role in improving oculomotor control and reading ability in this population group. This proposed study is the next step in this program of research and is a pilot clinical trial that will investigate whether 4 weeks of chiropractic care influences behavior, neurological function, or quality of life in children with ADHD.

Detailed Description

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ADHD is a disorder that may affect an individual's academic performance, social interactions, and interpersonal relationships amongst others. It is characterized by impulsiveness, hyperactivity, and inattention. It was previously thought that children overcome ADHD as they grow up, however, recent studies suggest that 30-60% of affected individuals continue to show significant symptoms of the disorder as adults and have associated difficulties such as lower educational and employment achievement. Conventional therapeutic approaches that are used with individuals with ADHD generally involve pharmaceutical interventions and behavioral therapies such as counseling and behavioral modification. However, little is known about the long term effectiveness of these treatment approaches which are also known to involve significant risks and complications.

ADHD is a neurodevelopmental disorder that is associated with significant alterations in brain development and function. These include changes in fronto-striatal pathways that can lead to difficulties with "top-down" control. It is also likely that connections in the parietal lobe and cerebellum are involved. These neurological changes are associated with a number of alterations to sensory filtering, sensorimotor gating, and sensorimotor control. This lends itself to a potential role for chiropractors in caring for children with ADHD because chiropractic care has been shown to alter a number of aspects of sensorimotor function.

Chiropractic is based on the theory that spinal adjustments applied to areas of spinal dysfunction, known as vertebral subluxations, can improve the function of the nervous system. Our research group has been testing this theory for the last 15 years. We have hypothesized that the articular dysfunction component of the vertebral subluxation results in altered afferent input to the central nervous system (CNS) that modifies the way in which the CNS processes and integrates all subsequent sensory input. This processing (i.e. sensorimotor integration), is a CNS function that appears most vulnerable to altered inputs. Recent studies have shown that chiropractic care alters sensorimotor filtering, cortical and cerebellar motor processing, and multisensory processing, all of which may be important in the neurodevelopment of ADHD. Given the nature of the neurological changes associated with ADHD and the growing body of evidence that suggests that chiropractic care may influence neurological function, it is possible that chiropractors may play a role in enhancing the neurological function of individuals with ADHD.

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Successful blinding of patients or practitioners in a trial involving a physical intervention such as chiropractic care is virtually impossible.18 This is due to the manual nature of the interventions and the challenges associated with providing appropriate sham procedures.18, 19 However, participants in this trial are highly likely to be naïve to chiropractic care so it is possible they will remain unaware of whether they are in the chiropractic or control group. Some study personnel will be aware of the allocated arm as they will be responsible for logistical aspects of the trial. However, the research specialist collecting and analyzing data during the trial will be blinded to group allocation.

Study Groups

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Experimental group

Chiropractic care

Group Type EXPERIMENTAL

Experimental group

Intervention Type OTHER

the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).

Control group

Usual health care

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Participants in the group will receive usual health (Cognitive-Behavioral, psychosocial Therapy) care or wish to engage in during the course of the study as well as receiving a passive movement control intervention delivered by a chiropractor 3 times per week in the same hospital setting as the group receiving chiropractic care.

Interventions

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Experimental group

the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).

Intervention Type OTHER

Control group

Participants in the group will receive usual health (Cognitive-Behavioral, psychosocial Therapy) care or wish to engage in during the course of the study as well as receiving a passive movement control intervention delivered by a chiropractor 3 times per week in the same hospital setting as the group receiving chiropractic care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* have been previously diagnosed with Attention Deficit Hypersensitivity Disorder based on the criteria outlined in the DSM-V.

Exclusion Criteria

* have absolute contraindications to chiropractic adjustments
* have experienced previous significant adverse reactions to chiropractic care or manual therapies.
* investigators are unable to get consent from parents and caregivers of participating children in the trial
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Imran Amjad, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Islamabad, Federal, Pakistan

Site Status

Countries

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Pakistan

References

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Harpin VA. The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child. 2005 Feb;90 Suppl 1(Suppl 1):i2-7. doi: 10.1136/adc.2004.059006.

Reference Type BACKGROUND
PMID: 15665153 (View on PubMed)

Munoz DP, Armstrong IT, Hampton KA, Moore KD. Altered control of visual fixation and saccadic eye movements in attention-deficit hyperactivity disorder. J Neurophysiol. 2003 Jul;90(1):503-14. doi: 10.1152/jn.00192.2003. Epub 2003 Apr 2.

Reference Type BACKGROUND
PMID: 12672781 (View on PubMed)

Sable JJ, Kyle MR, Knopf KL, Schully LT, Brooks MM, Parry KH, Diamond RE, Flink LA, Stowe R, Suna E, Thompson IA. The Sensory Gating Inventory as a potential diagnostic tool for attention-deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2012 Sep;4(3):141-4. doi: 10.1007/s12402-012-0079-1. Epub 2012 May 27.

Reference Type BACKGROUND
PMID: 22644992 (View on PubMed)

Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6.

Reference Type BACKGROUND
PMID: 22483612 (View on PubMed)

Henderson CN. The basis for spinal manipulation: chiropractic perspective of indications and theory. J Electromyogr Kinesiol. 2012 Oct;22(5):632-42. doi: 10.1016/j.jelekin.2012.03.008. Epub 2012 Apr 17.

Reference Type BACKGROUND
PMID: 22513367 (View on PubMed)

Daligadu J, Haavik H, Yielder PC, Baarbe J, Murphy B. Alterations in cortical and cerebellar motor processing in subclinical neck pain patients following spinal manipulation. J Manipulative Physiol Ther. 2013 Oct;36(8):527-37. doi: 10.1016/j.jmpt.2013.08.003. Epub 2013 Sep 12.

Reference Type BACKGROUND
PMID: 24035521 (View on PubMed)

Holt KR, Haavik H, Lee AC, Murphy B, Elley CR. Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated With Falls Risk in Older People: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2016 May;39(4):267-78. doi: 10.1016/j.jmpt.2016.02.003. Epub 2016 Apr 2.

Reference Type BACKGROUND
PMID: 27050038 (View on PubMed)

Karpouzis F, Bonello R, Pollard H. Chiropractic care for paediatric and adolescent Attention-Deficit/Hyperactivity Disorder: A systematic review. Chiropr Osteopat. 2010 Jun 2;18:13. doi: 10.1186/1746-1340-18-13.

Reference Type BACKGROUND
PMID: 20525195 (View on PubMed)

Rabe-Jablonska J. [Affective disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association -- diagnostic and statistical manual of mental disorders]. Psychiatr Pol. 1993 May-Jun;27(3):269-79. No abstract available. Polish.

Reference Type BACKGROUND
PMID: 8356173 (View on PubMed)

McGough JJ, Loo SK, Sturm A, Cowen J, Leuchter AF, Cook IA. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015 Mar-Apr;8(2):299-304. doi: 10.1016/j.brs.2014.11.013. Epub 2014 Nov 28.

Reference Type BACKGROUND
PMID: 25533244 (View on PubMed)

Conners CK. Rating scales in attention-deficit/hyperactivity disorder: use in assessment and treatment monitoring. J Clin Psychiatry. 1998;59 Suppl 7:24-30.

Reference Type BACKGROUND
PMID: 9680050 (View on PubMed)

Childress AC, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Findling RL. Participant-perceived quality of life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):210-7. doi: 10.1089/cap.2013.0077. Epub 2014 May 9.

Reference Type BACKGROUND
PMID: 24815910 (View on PubMed)

Rosner AL. Evidence-based medicine: revisiting the pyramid of priorities. J Bodyw Mov Ther. 2012 Jan;16(1):42-9. doi: 10.1016/j.jbmt.2011.05.003. Epub 2011 Jun 24.

Reference Type BACKGROUND
PMID: 22196426 (View on PubMed)

Hancock MJ, Maher CG, Latimer J, McAuley JH. Selecting an appropriate placebo for a trial of spinal manipulative therapy. Aust J Physiother. 2006;52(2):135-8. doi: 10.1016/s0004-9514(06)70049-6.

Reference Type BACKGROUND
PMID: 16764551 (View on PubMed)

Other Identifiers

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RiphahIU Imran khan Niazi2

Identifier Type: -

Identifier Source: org_study_id

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