Foot Levelers, Inc. sponsored two research studies on the effectiveness of functional orthotics. These studies verified that orthotics are considered very effective by a large percentage of wearers, and appear to have a positive effect on the lower body-half injury profile of college football players.
Custom-Made Orthotics as an Adjunct to Chiropractic Care: The Patient’s Perspective
Due to the lack of literature on the effectiveness of custom-made orthotics as an adjunct to Chiropractic care, a study on this subject was commissioned by Foot Levelers, Inc. and presented at the 2006 WFC convention in Australia. The goals of this study were to determine (1) what percentage of patients considered orthotics an effective adjunct to Chiropractic care and/or were satisfied with their functional orthotics and (2) if patient satisfaction varied with demographic category.
Chiropractors were recruited through mail advertisements promising modest inducements (one free pair of orthotics for every 10 questionnaires returned) to return completed questionnaires from consenting patients. Patient entry criteria were (1) eighteen years of age or older, (2) patient verbal informed consent, (3) wearing orthotics for at least one month and (4) currently under Chiropractic care. The type of Chiropractic care was not captured, only the conditions for which the patients were being treated. Custom-made functional orthotics were used and fitted by either scanning the feet or from foam impression casts. A 20-question questionnaire was completely sanitized before data entry to insure patient confidentiality. Data were analyzed for frequencies and means (where appropriate), using SPSS 10.0. Inter-variable analyses were conducted using SAS 8.02.
Five hundred twenty-seven (527) questionnaires were received from 59 Chiropractors. Demographic variables for the study are given in Table 4, and are sorted by gender in Table 1. Table 2 gives reported regions of responders’ pain, and Table 3 gives reported chief patient complaints. Responders had worn orthotics for means of 2.6 months for 8.6 hours/day and indicated it took 4.4 days to become accustomed to their orthotics. In efficacy-indicating questions, 92.5% indicated satisfaction with their orthotics, 88.5% indicated their orthotics were a good adjunct to their Chiropractic care, 55% said they were more active with their orthotics, and 88% indicated they would recommend orthotics to a friend.
Patient demographics for this study compared favorably to those reported for other Chiropractic use studies (see Tables 4 and 5). Patients also seemed to indicate a highly positive response on efficacy-related questions. Stepwise, logistic regression showed additional correlations not pre-determined as targets in this investigation. Females tended to be more physically active and more likely to recommend orthotics to a friend if they had a positive experience with orthotics. Hours per day wearing orthotics directly correlated with increased physical activity.
Limitations to these results included possible Chiropractor inexperience in research, use of a questionnaire that had been slightly modified after validation, and inability to determine relative contributions of Chiropractic care and orthotics (and/or the possibility of synergistic effects) in the results.
Despite study limitations, results over a wide range of age, gender, patient complaints and reasons for orthotic prescription clearly indicate that a high percentage of responders felt that orthotics were an important, effective part of their Chiropractic care and that they (the patients) felt the orthotics helped their pre-existing conditions.
The Effectiveness of Custom Orthotics at Reducing Injuries in a College Football Team
Brian Jensen, DC; William Austin, DC; J. N. Wilder, MS; Brent Ungar, DC; John Zhang, MD, PhD; Dennis Nosco, PhD, Mark Mandell, DC
American football is a violent sport involving high velocity directional changes and high velocity impact.10,11 The sport is performed by athletes of above-average strength, speed and, in many cases, weight. Lower-body-half (defined as from the lumbar spine down) injuries are common in football. While a number of studies have been published discussing ankle, knee, neck and mouth injuries and devices to make football safer, the incorporation of custom-made orthotics into football shoes to help prevent lower body-half injuries has, of yet, not been studied. Therefore an exploratory, historical control group study was conducted looking at the effect of custom-made orthotics on the injury rate for a college football team using the previous year’s injury rate as the control. The injury rate was determined by use of the college’s database of football injuries for the two seasons. The satisfaction of the football players with the orthotics and a comparison of injury self-reports for this and previous seasons were also considered as secondary indicators of the efficacy of the orthotics.
Inclusion criteria for this study were: a football player active on the team at the time of the start of the study, and a signed informed consent document. Exclusion criteria included failing to complete the season on the football team and/or failing to wear the orthotics for at least two weeks. Study participants filled out a pre-study questionnaire and were scanned by a local Chiropractor using Foot Levelers former digital scanner, the Associate™ Platinum. The digital information was used to create Ultra Tough® XT and Extreme™ XT custom-made orthotics.
The players were instructed to wear the orthotics in their football shoes for the entire season during practices and games, and were informed that they could stop the study at any time. The head trainer at the college monitored compliance. At the end of the study players were requested to fill out a post-study questionnaire. Data from the college injury database were gathered for the 2004 and 2005 seasons and data related to injuries of the lower-body-half were extracted. The data were coded and analyzed by a third party consultant. Statistical programs used included Microsoft Excel version 11.0 and SPSS, version 10.0.
Injuries in the lower body decreased from 148 in 2004 to 126 in 2005. Significant percentage drops (method of multiple proportions) were seen in knee injuries (29 to 20) and in lumbar spine injuries (14 to 7). Small drops in 2005 injuries from 2004 were seen in foot, ankle, lower leg, toes and patellar injuries, and small increases in 2005 were seen in hip and thigh injuries. All player groups (except wide receivers) reported above a neutral satisfaction level with their orthotics, although standard deviations and ranges were large for most groups.
Orthotic use enhances neuromuscular firing patterns of the lower extremity musculature and changes biomechanical function of the kinetic chain, including the Q angle of the knee (Fig. 2).12 It is possible that these factors unveiled pre-existing, sub-clinical myofascial barriers in the quadriceps musculature. Myofascial trigger points have been proposed to limit physical performance. Exceeding these physiological barriers as a result of improved performance is one theory of causation.
Players employing mostly forward movement in their positions and with limited cutting movements are more satisfied than players who backpedal or make quick changes in direction. This gives some indication of the groups that may benefit the most from the orthotics. Future studies will need to have a modified questionnaire based on the results from the current study and a historically more complete injury database in order for stronger conclusions to be drawn.
Custom-made functional orthotics appear to have a positive effect on the lower body of college football players. The orthotics also survived being worn throughout the college football season, indicating the ruggedness of the devices. Future studies are needed to elucidate the nature and absolute magnitude of any positive effect on injury rate and to determine which player positions and which individual players will benefit most from the use of custom-made orthotics.
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- Kuhn DR, Yochum TR, Cherry AR, Rodgers SS. Immediate changes in the quadriceps femoris angle after insertion of an orthotic device. J Manip Physiol Ther 2002 25(7):465-470.