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Table 2

Summary Chart of all 16 Clinical Trials Reviewed

ReferenceObjectiveTrial Design/50Patients/ConditionsInterventionsMain Outcome MeasuresFollow-Up PeriodMain Results/Conclusions
Bronfort, JMPT 2001To determine if SMT in addition to optimal medical management resulted in asthma-related outcomes in children. To assess the feasibility of conducting a full-scale, RCT in terms of recruitment, evaluation, treatment and ability to deliver sham SMT.Prospective clinical case series with observer blinded, pilot randomized and 1 year follow-up4836 patients 6–17 years old with mild to moderate asthma20 chiropractic treatments over the course of 3 months (active or sham SMT)Pulmonary function test, parental diary, parental Q of L form, severity, am/pm peak expiration flow.12 months post-treatment follow upAfter 3 months in combination with SMT and optimal medical management the children’s Q of L increased significantly and were maintained at 1 year follow up.
 No change in lung function or hyper-responsiveness. Improvements unlikely to be from SMT alone.
 Further research is required as to which aspect of the encounter is responsible for improvement.
Balon, NEJM 1998To compare the effect of true SMT to sham SMT on asthmatic children.RCT4580 children aged 7–16 years with mild to moderate asthmaTreatment group received SMT and STT. Control group received STT and pressure to spine. No changes to pretrial medication.Change from baseline of peak expiratory out-flow plus several other more qualitative outcomes.Immediate (journals) and 2 and 4 months.Small improvements in peak expiratory outflow as well as other indicators; no significant differences.
Rowe, Chiro Osteo 2006To conduct a pilot study and explore issues of safety, patient recruitment and compliance relevant to planning a RCT.Pilot RCT426 subjects over 6 months with idiopathic scoliosis.Standard medical care, standard medical care and chiropractic manipulation, standard care and sham manipulation.Cobb angle and scoliosis QLI.There were not enough subjects to compare outcomes between treatment groups, however the study was successful in providing researchers with information needed to plan a full-scale study.
Browning, Clin Chiro 2008To compare 2 interventions for infantile colic (SMT and OSD).Single-blinded, randomized comparison trial4143 infants less than 8 weeks old who cried >3 hr/day 4 out of the previous 7 days.SMT and OSDChange in daily hours crying.4 weeksBoth SMT and OSD had significant benefits in reducing infant colic.
 Both groups cried less and slept more after 2 weeks of treatment.
Olafsdottir, Arch Dis 2001To investigate the efficacy of chiropractic SMT in the management of infantile colic.Randomized, blinded, placebo controlled clinical trial3786 infantsSMT and controlParent diaries of hours crying.8–14 daysChiropractic SMT is no more effective than placebo in the treatment of colic.
Wiberg & Nordsreen, JMPT 1999To determine if there is a short-term effect of SMT in the management of infantile colic.RCT3741 infants aged 2–10 weeksSMT and dimethiconeParent diaries of hours crying.Immediate or noneDuring days 4–7 crying decreased 1 hour in dimethicone group and 2.4 hours in SMT group.
 During days 8–11 crying decreased 1 hour in dimethicone group and 2.7 hours in SMT group.
Sawyer, JMPT 1999A pilot study assessing the feasibility of conducting a full scale RCT investigating the efficacy of SMT for children with chronic otitis media with effusion.Prospective, parallel-group, observer-blinded, randomized feasibility study3622 patients age 6 months to 6 years.SMT or sham SMTParent diaries, presence or absence of effusion.4 weeksRecruitment is feasible. Parents are compliant with daily diaries and willing to participate in active and sham SMT.
 Objective outcomes involving tympanometry and otoscopy are extremely challenging and should be performed by validated examiners in future studies.
Sandell, JCM 2007To investigate the effect of chiropractic treatment on hip joint extension ability and running velocity.Prospective, randomized, controlled experimental pilot study3417 male middle distance runners age 17–20.SMT and controlHip extension and running velocityImmediate or noneTreatment group showed significantly greater hip extension ability after chiropractic treatment than controls.
 Treatment group did not show a significant decrease in time for running 30 m after treatment.
Reed, JMPT 1994To evaluate chiropractic management of primary nocturnal enuresis in children.Controlled clinical trial for 10 weeks plus 2 weeks post of non-treatment3346 children (31 in treatment group and 15 in control group).High velocity short lever SMT or sham SMTFrequency of “wet” nights2 weeksBaseline treatment group had 9.1 nights/2 weeks wet.
 Post treatment group had 7.6 nights/2 weeks wet.
 Baseline control had 11.1 nights/2 weeks wet.
 Post treatment group had no change.
Straub, JMPT 2001To determine the effect of chiropractic care on jet lag in athletes travelling from Finland to the USA and returning to Finland.Randomized (blinded in the sham and active groups) in 3 groups2615 Finnish junior elite athletes, ranged 6–21 years (mean age 18.3 years).Sham SMT, active SMT, control group (toggle/recoil procedure)Psychological assessment POMS, heart rate, sleep disturbances, jet lag evaluation.5 day follow up after returning to Finland.Chiropractic care does not reduce the effects of jet lag.
Lebouef, JMPT 1991To observe the effect of SMT on nocturnal enuresis.Prospective study25171 children aged 4–15 years (mean age 8.3).SMT; 94% received upper cervicalParental diaries, clinician assessment (hours crying, intensity, feeding, stools).None but checked in at 1, 2 and 4 weeks.85% better or stopped at 1 week.
 95% better or stopped at 2 weeks.
 97% better or stopped at 4 weeks.
Khorshid, JVSR 2006To identify the difference in efficacy between upper cervical and full spine adjustment in autistic children.Randomized clinical trial2314 autistic childrenAtlas Orthogonal upper cervical adjustment or full spine adjustment.Autism Treatment Evaluation Checklist (ATEC), leg length analysis & x-rays.Immediate or nonImprovement of ATEC scores was seen in 6/7 children under upper cervical adjustment and in 5/7 children under full spine adjustment.
Miller & Miller JMPT 2009To describe the circumstances, clinical features, role, and results of chiropractic management of infants who were referred to a chiropractic clinic for failure to adequately feel at the breast.Clinicial case series22114 infants (12 weeks or younger) cases of hospital-diagnosed or lactation consultant diagnosed feeding problems that were treated with chiropractic therapy in addition to routine care and followed to short-term result.Treatment aimed at releasing the area of tension, imbalance or pain producing tissue through routine low force chiropractic manual therapy.Outcome after treatment was based on mother’s rating of improvement in their infant’s symptoms. This was a form of a 10-point numerical rating scale as well as discussion with the parentsShort termTreatment was chiropractic therapy in addition to any support given elsewhere. All children showed some improvement with 78% being able to exclusively breastfeed after 2 to 5 treatments within a 2-week time period.
 Cooperative multidisciplinary care to support breastfeeding was demonstrated in this population. Chiropractic treatment may be a useful adjunct to routine care given by other professionals in cases of diagnosed breastfeeding problems with a biomechanical component.
Klougart, JMPT 1989To observe the effect of regular PSMT on colicky infants.Prospective uncontrolled study21316 infants age 2–52 weeks.SMT at the discretion of the 73 Chiropractors involvedParental diaries and clinician assessments performed after 1, 2 and 4 weeks post treatment.A similar evaluation performed at the 14-day mark was performed at 4 weeks to estimate relapses.SMT of the vertebral column in infants with colic constitutes effective treatment. Results show a satisfactory effect of the treatment in 94% of cases within 14 days from the start of treatment.
 Further studies must be designed in such a way that the number of sources of bias affecting the interpretation of results is reduced. This will more closely estimate a placebo effect.
Wiberg, JMPT 2010To investigate if the outcomes of excessively crying infants treated with chiropractic care was associated with age and/or can be partially explained by age.Retrospective evaluation19276 infants who fit the inclusion criteria.Chiropractic manipulation as decided by the treating Chiropractor.Parental reports were noted as improved un-certain, or non-recovered.None or immediate follow upData matched the clinical experience of good treatment effect independent of the infant’s age.
 Slightly older age and longer duration of treatment were found to explain co-variables linked to crying infant’s improvement.
Miller, JMPT 2008To identify adverse effects of PSMT on children under the age of three years to evaluate risk of complications.3 year retrospective study18697 children under the age of three years with colic and/or irritability due to biomechanical disorders likely resulting from birth trauma.77% received full spine PSMT; others received cervical spine decompression, segmental SMT etc.Parental perception of improvement, no change or worsening of symptoms.Immediate or none85% improved. 15% showed no change.
 ~1% had an adverse reaction (n = 7) and 3 of 7 were perceived to be regular side effects of PSMT.
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