Author Names

Haugen, E., Benth, J., Nakstad, B.

Reviewer Name

Alexandra Hultstrom, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

 

Paper Abstract

Aim: Torticollis in infancy is routinely treated by child physiotherapists. The addition of manual therapy to the treatment is a new approach in Norway. As the effect of manual therapy for this condition is poorly documented, we designed a pilot study to evaluate measurement methods and examine the short-time effect of manual therapy in addition to child physiotherapy. Methods: Randomized controlled trial, double blinded. Thirty-two patients aged 3–6 months were randomized to intervention group (manual therapy and child physiotherapy) and control group (child physiotherapy alone). Primary outcome: Change of symptoms because of torticollis evaluated by video recordings. Secondary outcomes: 12 parameters including spontaneous movements, active and passive range of motion and head righting reaction. Results: We found a nonsignificant tendency to greater improvement in lateral flexion (p = 0.092) and head righting reaction (p = 0.116) in the intervention group. Conclusion: In this pilot study, we found that in patients with moderate symptoms related to torticollis, the short-time effect of manual therapy in addition to physiotherapy is not significantly better than physiotherapy alone.

 

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • Yes
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • No
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

There were no significant differences between the two groups for the primary (change of symptoms due to torticollis evaluated by video recordings) or secondary (12 parameters including spontaneous movement, AROM, PROM, and head righting) outcome measures.

Key Finding #2

The intervention group had slightly better outcomes in passive (p=0.116) and active (p=0.092) lateral flexion against gravity than the control group from inclusion to week 8.

Key Finding #3

There was a slight, short-term improvement in children with moderate torticollis with manual therapy in addition to traditional physiotherapy than physiotherapy alone.

Key Finding #4

Overall, manual therapy in infants remains controversial due to the lack of documentation in scientific studies.

 

Please provide your summary of the paper

Congenital Muscular Torticollis is a common diagnosis in infants and toddlers that has been shown to improve with physiotherapy treatment involving passive and active movement exercise and encouragement of symmetrical motor performance. Germany has been using manual therapy to treat infants with torticollis for years as they believe that the cause is due to functional disturbance of the joints (AA and AO) and describe it as “Kinematic Imbalance due to Suboccipital Strain” (KISS). Manipulation is performed with the child in supine and the head in neutral without any extension and only a moderate force application. 32 children with torticollis ages 3-6 months were recruited for the study and randomly assigned to intervention or control groups. Inclusion criteria were reduced mobility in the neck in at least one axial plane and exclusion criteria were other cause of asymmetry or serious pathology. At inclusion, week 2, and week 8 the patients underwent clinical examination by an experienced pediatric physiotherapist and these sessions were recorded for analysis by 3 blinded, independent assessors. The manual therapist providing intervention was the only one who knew of group assignment as the parents and assessing physiotherapist were both blinded. Overall, there were no significant differences between the intervention and control groups between the primary or secondary outcomes and there was only a slight, short term improvement noted in the intervention group.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

This study opens the door to continued research into the safety and efficacy of adding manual therapy to the standard physical therapy treatment for torticollis. However, there were still multiple limitations to the study and the differences noted between the experimental and control groups were small. The sample was not representative of the whole population of children with torticollis and the study size was small with only 32 participants. There were also issues with the reliability of measurements due to the variability of activity level and cooperation of the children during examination. Finally, the children with severe torticollis were excluded from the study as they had already received manual therapy, but they may have demonstrated the greatest improvements.