This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.
<b>OBJECTIVE: </b>To compare the effectiveness of prefabricated foot orthoses to rocker-sole footwear in reducing foot pain in people with first metatarsophalangeal (MTP) joint osteoarthritis (OA).<b>METHODS: </b>Participants (n = 102) with first MTP joint OA were randomly allocated to receive individualized, prefabricated foot orthoses or rocker-sole footwear. The primary outcome measure was the pain subscale on the Foot Health Status Questionnaire (FHSQ) at 12 weeks. Secondary outcome measures included the function, footwear, and general foot health subscales of the FHSQ; the Foot Function Index; severity of pain and stiffness at the first MTP joint; perception of global improvement; general health status; use of rescue medication and co-interventions to relieve pain; physical activity; and the frequency of self-reported adverse events.<b>RESULTS: </b>The FHSQ pain subscale scores improved in both groups, but no statistically significant difference between the groups was observed (adjusted mean difference 2.05 points, 95% confidence interval [95% CI] -3.61, 7.71; P = 0.477). However, the footwear group exhibited lower adherence (mean ± SD total hours worn 287 ± 193 versus 448 ± 234; P < 0.001), were less likely to report global improvement in symptoms (39% versus 62%; relative risk [RR] 0.63, 95% CI 0.41, 0.99; P = 0.043), and were more likely to experience adverse events (39% versus 16%; RR 2.47, 95% CI 1.12, 5.44; P = 0.024) compared to the orthoses group.<b>CONCLUSION: </b>Prefabricated foot orthoses and rocker-sole footwear are similarly effective at reducing foot pain in people with first MTP joint OA. However, prefabricated foot orthoses may be the intervention of choice due to greater adherence and fewer associated adverse events.
<b>PURPOSE: </b>Functional treatment is the optimal non-surgical treatment for acute lateral ankle ligament injury (ALALI) in favour of immobilization treatment. There is no single most effective functional treatment (tape, semi-rigid brace or lace-up brace) based on currently available randomized trials.<b>METHODS: </b>This study is designed as a randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grades II and III ALALIs. The Karlsson score and the FAOS were evaluated at 6-month follow-up.<b>RESULTS: </b>One hundred and ninety-three patients (52% males) were randomized, 66 patients were treated with tape, 58 patients with a semi-rigid brace and 62 patients with a lace-up brace. There were no significant differences in any baseline characteristics between the three groups. Mean age of the patients was 37.3 years (35.1-39.5; SD 15.3). Ninety-five males (49%) were included. One hundred and sixty-one (59 + 50 + 52) patients completed the study through final follow-up; 32% lost at follow-up. In two patients treated with tape support, the treatment was changed to a semi-rigid brace because of dermatomal blisters. Except for the difference in Foot and Ankle Outcome Score sport between the lace-up and the semi-rigid brace, there are no differences in any of the outcomes after 6-month follow-up.<b>CONCLUSION: </b>The most important finding of current study was that there is no difference in outcome 6 months after treatment with tape, semi-rigid brace and a lace-up brace.<b>LEVEL OF EVIDENCE: </b>I.
INTRODUCTION: Purpose of the study was the evaluation of the early functional outcome of patients with an acute ankle sprain treated either with a semirigid, variable, phase-adapted modular ankle orthosis or an invariable orthotic reference device.
MATERIALS AND METHODS: Forty-seven patients with acute ankle sprain grade II or more were included. In addition, 77 healthy controls as a reference were investigated. The injured subjects were treated with one of the two devices by random for 6 weeks. Ankle scores (FAOS, AOFAS) were taken at baseline after injury, 1 and 3 months after injury. Functional performance tests (balance platform, zig zag run, shuttle run, vertical drop jump) were performed at 1 and 3 months after injury.
RESULTS: No significant score differences could be found between the two intervention groups except for achieving a preinjury activity level after 3 months only in the modular orthosis group. Postural functional performances (balance test) also showed no significant differences whereas the results of the agility tests revealed small but significant better results in the modular orthosis group in comparison to the invariable orthosis group. Cohen's effect sizes were high.
CONCLUSION: Differences between the two intervention groups were marginal and very small but significant and--regarding Cohen's effect sizes--effective. Especially relating to functional performance, this might be a careful indication that a more effective strategy for promoting a protected, rapid recovery to physical activity after ankle sprains might be achieved by applying a phase-adapted ankle orthosis. Especially in athletic patients, phase-adapted orthosis should be further investigated and considered to ensure fully protected ligament healing as well as to regain early functional recovery.
BACKGROUND: The results of conservative treatment of knee osteoarthritis (OA) are generally evaluated in epidemiological studies with clinical outcome measures as primary outcomes. Biomechanical evaluation of orthoses shows that there are potentially beneficial biomechanical changes to joint loading; however, evaluation in relation to clinical outcome measures in longitudinal studies is needed.
QUESTIONS/PURPOSES: We asked (1) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace; (2) is there a late (6 weeks) effect; and (3) is there a difference between subgroups within each group with respect to patient compliance, body mass index, and OA status?
METHODS: This was a secondary analysis of data from a previous randomized controlled trial of patients with early medial knee OA. A total of 91 patients were enrolled in that trial, and 73 (80%) completed it after 6 months. Of the enrolled patients, 80 (88%) met prespecified inclusion criteria for analysis in the present study. The patients were randomized to an insole or brace. Gait was analyzed with and without wearing the orthosis (insole or brace) at baseline and after 6 weeks. Measurements were taken of the knee adduction moment, ground reaction force, moment arm, walking speed, and toe-out angle. Data were analyzed with regression analyses based on an intention-to-treat principle.
RESULTS: A mean reduction of 4% (±10) (95% confidence interval [CI], -0.147 to -0.03, p=0.003) of the peak knee adduction moment and 4% (±13) (95% CI, -0.009 to -0.001, p=0.01) of the moment arm at baseline was observed in the insole group when walking with an insole was compared with walking without an insole. A mean reduction of 1% (±10) (95% CI, -0.002 to -0.001, p=0.001) of the peak knee adduction moment and no reduction of the moment arm were measured after 6 weeks. No reduction of knee adduction moment, moment arm, or ground reaction force was seen in the brace group at baseline and after 6 weeks. Subgroup analysis showed no differences in biomechanical effect for obesity, stage of OA, and whether patients showed a clinical response to the treatment.
CONCLUSIONS: Laterally wedged insoles unload the medial compartment only at baseline in patients with varus alignment and by an amount that might not be clinically important. No biomechanical alteration was seen after 6 weeks of wearing the insole. Valgus brace therapy did not result in any biomechanical alteration. Taken together, this study does not show a clinically relevant biomechanical effect of insole and brace therapy in patients with varus medial knee OA.
LEVEL OF EVIDENCE: Level I, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
OBJECTIVE: To assess the effectiveness of total contact insoles (TCI) in patients with plantar fasciitis (PF).
METHODS: A double-blind randomized controlled trial was carried out with intention-to-treat analysis. Seventy-four patients were randomly allocated to use a TCI made of ethylene vinyl acetate (study group, n = 37) or a flat insole (control group, n = 37). The following assessment tools were used: visual analog scale for pain while walking and at rest, Medical Outcomes Study Short Form-36 (SF-36) for quality of life, Foot Function Index and Foot Health Status Questionnaire for foot function, 6-min walk test (6MWT), and baropodometer FootWalk Pro for plantar pressure analysis. The groups were evaluated by a blinded assessor at baseline and after 45, 90, and 180 days.
RESULTS: The groups were homogeneous for the majority of variables at baseline. The over-time comparisons show a statistical difference between the groups for pain while walking (p = 0.008) and the 6MWT (p = 0.010). Both groups showed significant improvements in pain at rest, foot function, and some quality of life variables (physical functioning, bodily pain, vitality, and social functioning), with no significant statistical differences between them. The baropodometer recorded no changes from the use of the insoles.
CONCLUSION: A TCI can be used to reduce pain while walking and to increase walking distance in individuals with PF.
OBJECTIVE: To compare the efficacy of a 12-week non-surgical treatment program with usual care in patients with knee osteoarthritis (OA) not eligible for total knee replacement (TKR).
METHOD: This two-arm parallel group assessor-blinded randomized controlled trial (RCT) included 100 adults from secondary care with knee OA, confirmed by radiography (Kellgren-Lawrence grade ≥1), but not eligible for a TKR. The 12-week non-surgical treatment program consisted of individualized progressed neuromuscular exercise, patient education, insoles, dietary advice and prescription of pain medication if indicated, while usual care comprised two leaflets with information and advice on knee OA and recommended treatments. The primary outcome was the change from baseline to 12 months in the Knee injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the KOOS subscales of pain, symptoms, activities of daily living (ADL), and quality of life (QOL).
RESULTS: 91% of the patients completed the 12 months follow-up on the primary outcome. Compared with usual care, patients undergoing the treatment program improved more in KOOS4 (adjusted mean difference (95% CI) of 9.6 (4.4-14.8)) with no serious treatment-related adverse events (AE). The number needed to treat (NNT), defined as the number of patients needed to treat for one person to improve 15% was 7.2. Secondary outcomes supported the primary findings.
CONCLUSION: In patients with mostly moderate to severe knee OA not eligible for TKR, a 12-week individualized, non-surgical treatment program is more efficacious at 12 months compared with usual care and has few treatment-related AE.
TRIAL REGISTRATION: ClinicalTrials.gov (NCT01535001).
BACKGROUND: Osteoporosis is one of the major health problems in aging population and may lead to osteoporotic vertebral fracture that causes severe back pain and reduced functional independency.
OBJECTIVES: To compare the efficacy of SpinoMed® and soft lumbar orthosis at the subacute stage (the second and third weeks of disease onset) of the patients with osteoporotic vertebral fracture.
STUDY DESIGN: Prospective randomized trial, pilot trial.
METHODS: A total of 51 female subjects aged 55 years or above with osteoporotic vertebral fracture were randomly distributed to the soft lumbar orthosis (control group, n = 24) and SpinoMed® (test group, n = 27) groups after the acute stage (the first week of disease onset). The pain level was assessed by obtaining verbally feedback in 10-point scale scoring, while functional mobility level was estimated with Functional Independence Measure-motor Scores, Elderly Mobility Scale, and Modified Functional Ambulation Category. The thoracic kyphosis angle was measured from standing X-ray on 10 out of 51 subjects.
RESULTS AND CONCLUSION: Both groups showed significant reduction in the patients' pain level and limitations of daily life (p < 0.05). The effect of the two types of spinal orthoses on the pain level reduction and functional mobility level gain did not show significant difference (p > 0.05) at the subacute stage.
CLINICAL RELEVANCE: In this study, SpinoMed® could not provide additional treatment benefits to patients with osteoporotic vertebral fracture regarding pain relief and functional independence improvement at the subacute stage. The effects of SpinoMed® in muscle-strengthening and thoracic kyphotic angle reduction for patients with osteoporotic vertebral fracture need to be further verified in a more intensive and longer-term training program.
This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.
