Introduction

It is recommended that non-operative treatment of knee osteoarthritis (KOA) should be individually tailored and include multiple treatment modalities. Despite these recommendations, no one has yet investigated the efficacy of combining several non-surgical treatment modalities in a randomised controlled study. The purpose of this randomised controlled study is to examine if an optimised, combined non-surgical treatment programme results in greater improvements in pain, function and quality of life in comparison with usual care in patients with KOA who are not eligible for total knee arthroplasty (TKA).

Methods and analysis

This study will include 100 consecutive patients from the North Denmark Region not eligible for TKA with radiographic KOA (K-L grade ≥1) and mean pain during the previous week of ≤60 mm (0–100). The participants will be randomised to receive either a 12-week non-surgical treatment programme consisting of patient education, exercise, diet, insoles, paracetamol and/or NSAIDs or usual care (two information leaflets containing information on KOA and advice regarding the above non-surgical treatment). The primary outcome will be the change from baseline to 12 months on the self-report questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living and quality of life. Secondary outcomes include the five individual KOOS subscale scores, pain on a 100 mm Visual Analogue Scale, EQ-5D, self-efficacy, pain pressure thresholds, postural control and isometric knee flexion and knee extension strength.

Ethics and dissemination

This study was approved by the local Ethics Committee of The North Denmark Region (N-20110085) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by April 2014. Publications will be ready for submission in the summer of 2014.

Trial registration number

This study is registered with http://clinicaltrials.gov (NCT01535001).

Background

There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain.

Methods/Design

The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0–100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength.

Discussion

This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.

Trial registration

Clinicaltrials.gov reference: NCT01410409

Background

Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents.

Methods/Design

This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises.

The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months.

Discussion

This study is designed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy. If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective, it may serve as a basis for optimising the clinical pathway for those suffering from the condition, where specific emphasis can be placed on early diagnosis and early treatment.

Trial Registration

clinicaltrials.gov reference: NCT01438762

Analysis of foot movement is essential in the treatment and prevention of foot-related disorders. Measuring the in-shoe foot movement during everyday activities, such as sports, has the potential to become an important diagnostic tool in clinical practice. The current paper describes the development of a thin, flexible and robust capacitive strain sensor for the in-shoe measurement of the navicular drop. The navicular drop is a well-recognized measure of foot movement. The position of the strain sensor on the foot was analyzed to determine the optimal points of attachment. The sensor was evaluated against a state-of-the-art video-based system that tracks reflective markers on the bare foot. Preliminary experimental results show that the developed strain sensor is able to measure navicular drop on the bare foot with an accuracy on par with the video-based system and with a high reproducibility. Temporal comparison of video-based, barefoot and in-shoe measurements indicate that the developed sensor measures the navicular drop accurately in shoes and can be used without any discomfort for the user.

Background

The navicular drop test is a measure to evaluate the function of the medial longitudinal arch, which is important for examination of patients with overuse injuries. Conflicting results have been found with regard to differences in navicular drop between healthy and injured participants. Normal values have not yet been established as foot length, age, gender, and Body Mass Index (BMI) may influence the navicular drop. The purpose of the study was to investigate the influence of foot length, age, gender, and BMI on the navicular drop during walking.

Methods

Navicular drop was measured with a novel technique (Video Sequence Analysis, VSA) using 2D video. Flat reflective markers were placed on the medial side of the calcaneus, the navicular tuberosity, and the head of the first metatarsal bone. The navicular drop was calculated as the perpendicular distance between the marker on the navicular tuberosity and the line between the markers on calcaneus and first metatarsal head. The distance between the floor and the line in standing position between the markers on calcaneus and first metatarsal were added afterwards.

Results

280 randomly selected participants without any foot problems were analysed during treadmill walking (144 men, 136 women). Foot length had a significant influence on the navicular drop in both men (p < 0.001) and women (p = 0.015), whereas no significant effect was found of age (p = 0.27) or BMI (p = 0.88). Per 10 mm increase in foot length, the navicular drop increased by 0.40 mm for males and 0.31 mm for females. Linear models were created to calculate the navicular drop relative to foot length.

Conclusion

The study demonstrated that the dynamic navicular drop is influenced by foot length and gender. Lack of adjustment for these factors may explain, at least to some extent, the disagreement between previous studies on navicular drop. Future studies should account for differences in these parameters.