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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 34  |  Issue : 2  |  Page : 106-111

Study of effectiveness of lateral wedge insole on medial compartment of osteoarthritis of knee treated with viscosupplementation


1 Department of Physical Medicine and Rehabilitation, AIIMS, Rishikesh, Uttarakhand, India
2 Department of Physical Medicine and Rehabilitation, VMMC and Safdarjung Hospital, New Delhi, India
3 Department of Physical Medicine and Rehabilitation, IGIMS, Patna, Bihar, India
4 Department of Anaesthesiology and Critical Care, AIIMS, Rishikesh, Uttarakhand, India

Date of Submission20-Apr-2020
Date of Decision07-May-2020
Date of Acceptance28-May-2020
Date of Web Publication06-Aug-2020

Correspondence Address:
Dr. Ajay Gupta
Department of Physical Medicine and Rehabilitation, VMMC and Safdarjung Hospital, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijpn.ijpn_48_20

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  Abstract 


Context: Knee Osteoarthritis (OA) is a common disorder affecting the elderly population in the Asia-Pacific region. The goals of OA treatment include alleviation of pain and improvement of functional status. There is lack of consensuses regarding the management of knee OA. Aims: The main aim of this study is to evaluate any synergistic effect of adding lateral wedge insoles to viscosupplementation. Settings and Design: This is a randomized interventional study in which total 60 patients were selected from a tertiary care center and divided in two equal groups using computerized block randomization. Methods and Material: Group A got only VS while Group B got VS with LWI. Assessment was done at baseline and then after 2nd, 4th and 12thweeks after the intervention by using Visual Analogue Scale (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function and Health Assessment Questionnaire (HAQ) for quality of life. Statistical Analysis Used: The data were entered in MS EXCEL spreadsheet and analysed by using Statistical Package for Social Sciences (SPSS) version 21.0. Results: In this study all the patients in both group showed statistically significant improvement in VAS, WOMAC and HAQ on all three follow-ups over the baseline assessment (P value < 0.0005). On inter-group comparison, statistically significant better results were noticed in the WOMAC scores of group B at 2nd week and 4th week (P value <0.0005) on follow up over group A. The statistically better result in group B on WOMAC was not seen at the 12 week follow up. Conclusions: Viscosupplementation has significant role in OA knee management. Intra articular Hyaluronic acid injection improves significantly the pain, function and quality of life of moderate grade OA Knee patients. Addition of Lateral wedge insole in the treatment gave initial relief in stiffness and function but not on subjective pain felt or on quality of life. Also, in long-term, it had no added advantage over viscosupplementation.

Keywords: Health assessment questionnaire, lateral wedge insole, osteoarthritis, viscosupplementation, Western Ontario and McMaster Universities Osteoarthritis Index


How to cite this article:
Kanaujia V, Gupta A, Sharma DK, Verma S, Yadav RK. Study of effectiveness of lateral wedge insole on medial compartment of osteoarthritis of knee treated with viscosupplementation. Indian J Pain 2020;34:106-11

How to cite this URL:
Kanaujia V, Gupta A, Sharma DK, Verma S, Yadav RK. Study of effectiveness of lateral wedge insole on medial compartment of osteoarthritis of knee treated with viscosupplementation. Indian J Pain [serial online] 2020 [cited 2020 Oct 29];34:106-11. Available from: https://www.indianjpain.org/text.asp?2020/34/2/106/291545




  Introduction Top


Knee osteoarthritis (OA) has emerged as the leading cause of chronic disability and eleventh highest contributor to global disability.[1] It is a degenerative joint disease which causes loss of articular cartilage, biochemical changes in synovial fluid (SF), loss of SF, and morphological damage to other joint tissues. Numerous repair mechanisms attempt to restore normal function within the damaged joint to ensure that joint continues to dissipate load correctly. When the rate of damage exceeds the rate of repair, degeneration of the bone and cartilage ensues and the joint fails to effectively dissipate load. These results in a cycle of biomechanical and biochemical degeneration, where the shock-absorbing cartilage is progressively destroyed, exposing the bone to greater load and leading to bone damage.[2] OA typically affects the knee joint in nonuniform manner. The medial compartment is affected more than the lateral compartment because of higher varus forces during weight bearing activities such as walking.[3] This varus torque is nearly 2.5 times the force through the lateral compartment of the knee which produces the varus deformity at the knee in vicious manner. The goals of OA treatment include alleviation of pain and improvement of functional status, which include nonpharmacologic and pharmacologic treatment. Nonpharmacologic interventions include patient education, lifestyle modification, weight loss, physical modalities, exercise, physical therapy, occupational therapy, assistive technology and adaptations, footwear, and sole modifications. Oral NSAIDs, topical NSAIDs, and tramadol are recommended as pharmacological treatment by the American Academy of Orthopedic Surgeons (AAOS). Along with this, intra-articular corticosteroids and intra-articular hyaluronic acid are also used for symptomatic OA of the knee.[4]

Viscosupplementation (VS) is becoming a more widely accepted and practiced mode of treatment for symptomatic OA of the knee. Intra-articular injection of hyaluronic acid into joints restores the rheological properties of the SF, promotes the endogenous synthesis of a higher molecular weight and possibly more functional hyaluronan, thereby improving mobility, articular function, and decreasing pain. There are various orthoses, which change the biomechanics of knee. During walking, the normal forces acting on the leg produce a varus torque (i.e., a torque tending to adduct the knee into varus).[5] This varus torque is directly associated with the compressive force across the medial aspect of the knee, which is nearly 2.5 times the force through the lateral aspect of the knee. The fact that this varus torque is believed to be responsible for the progression of knee OA is supported by data from both animal and clinical studies.[6] Lateral wedge insole (LWI) causes a change in varus knee torque in medial compartment OA of knee, which results in symptomatic improvement in OA of the knee.[7]

The aim of this study was to check the effectiveness of two treatment options (VS and LWI) with a different mechanism of action in the treatment of OA of knee on clinical parameters. The primary objective of the study was to compare the effect of LWI and VS (Group B) with VS alone (Group A) over pain (Visual analogue scale [VAS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and quality of life (Health assessment questionnaire [HAQ]) in OA knee. Secondary objective was to check the improvement within the groups.


  Subjects and Methods Top


This study was a single-centered randomized, interventional study conducted in the Department of Physical Medicine and Rehabilitation (PMR) of VMMC and Safdarjung Hospital from September 2014 to January 2016. For the diagnosis of OA we use clinical and radiographic criteria of the American College of Rheumatology (ACR).[8] For radiological diagnosis, we use Kellgren–Lawrence Grading Scale.[9] Patients were selected from the outpatient department of PMR after satisfying the inclusion criteria (age > 40 years, pain of at least 3 [using an 0–10 VAS] after physical activities, joint space narrowing in the medial compartment of the knee, Kellgren and Lawrence Grade 2 and Grade 3 and ambulatory patients, having a usual weight bearing activities of at least 2 h a day) and exclusion criteria (body mass index > 25 unit kg/m2, secondary knee OA, hip OA, hallux rigidus, valgus deformity of the midfoot, advanced arthropathy of the hind foot, knee joint lavage within the previous 3 months, intra-articular corticosteroid injection in last 1 month, chronic diseases such as rheumatoid arthritis, diabetes mellitus, peripheral vascular disease, gout, clotting disorders, and any patient complaining of severe increase in pain during the treatment washout period and not satisfied with the rescue medication will be considered primarily excluded.

The study of Raman, et al.[10] observed that in hylan group, WOMAC at 12 weeks was 17.7. Taking this value as a reference and assuming difference of 25% in WOMAC between the two groups and standard deviation (SD) of 5, the minimum required sample size with 80% power of study and 5% level of significance, was 21 in each group. Formula used was N ≥ 2 (standard deviation) 2 X (Zα + Zβ) 2/(mean difference) 2. Where Zα is value of Z at two-sided alpha error of 5% and Zβ is value of Z at power of 80% and mean difference is difference in mean values of two groups.

Assuming 5% drop out rate sample size was 22.10 per group. To reduce margin of error, total sample size was taken 60 (30 patients per group) [Figure 1].
Figure 1: Consort flow chart

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Patients were randomized by computer-generated sequences and allocated in two parallel groups with allocation ratio of 1:1. This was an open-label prospective study. Group A got only VS and Group B got LWI along with VS. We have taken single-dose injection hyaluronic acid 90 mg/3 ml (cross-linked, nonavian source with a molecular weight of 4–5 million Dalton) and it was given in the affected knee using palpatory anterolateral approach.[11]

The wedged insoles were laterally inclined 5°–8° approximately, along the full length of the insole from hind foot to forefoot with the average thickness of 3.2 mm [Figure 2]. The material used was ethyl vinyl acetate. All of the insoles were trimmed along the perimeter of each subject's feet to fit inside the subject's own comfortable shoes and advised to use the wedge in footwear during all weight bearing activities in the day (at least 6 h a day). All subjects were allowed to use only paracetamol 500 mg tablet orally as rescue medication for the entire period and same to be noted. They were advised to do range of motion exercises for 3–5 min every 2 h during a day and strengthening exercises (leg extension, seated leg press, and leg raise) with 3 sets of 10 repetitions of each exercise for 5 days per week.
Figure 2: Lateral wedge insole

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All patients were assessed at the time of intervention (0 week) and then at 2nd week, 4th week, and 12th week after the intervention for change in pain, function, and quality of life. For pain VAS ranging from 0 (no pain) to 10 (worst pain), for function WOMAC (Modified – CRD Pune Version) and for quality of life by HAQ (Modified – CRD Pune Version) were used.[12]

In the statistical analysis, categorical variables were presented in number and percentage (%) and continuous variables were presented as mean ± SD and median. The normality of data was tested by Kolmogorov–Smirnov test. If the normality was rejected, then nonparametric test was used. Quantitative variables were compared using unpaired t-test (WOMAC and HAQ) and Mann–Whitney Test (VAS) between the two groups. Within the group across follow–ups, Paired t-test (WOMAC and HAQ)/Wilcoxon test (VAS) were used. Qualitative variables were compared using Chi-square test/Fisher's exact test. A “P” < 0.05 was considered statistically significant. The data were entered into MS Excel spreadsheet and analysis was done using Statistical Package for Social Sciences (version 21.0, IBM, Chicago, USA).


  Results Top


In this study, Group A (only VS) got 12 males and 18 females and Group B (VS + LWI), got 8 males and 22 females. In Group A (only VS), 11 subjects were of KL Grade 2 and 19 were of KL Grade 3. In Group B (VS + LWI), 15 subjects were KL Grade 2 and 15 subjects were KL Grade 3 [Table 1]. On within group comparison Group A (only VS) and Group B (VS + LWI), both shows statistically significant result in VAS score, total WOMAC score and HAQ score on comparison from 0 week to 2nd, 4th, and 12th weeks (P < 0.0005) [Table 2] and [Table 3]. On across the group comparison, VAS and HAQ showed no statistically significant improvement but difference in WOMAC score was significant at 2nd and 4th week, which became insignificant at 12th week [Table 4]. One patient from Group B dropped out from follow-up without any information/reason [Figure 1]. No serious adverse effect reported by the participants during the entire duration of the study.
Table 1: Baseline Characteristics of the subjects

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Table 2: Comparison of VAS, WOMAC and HAQ score in Group A (VS only)

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Table 3: Comparison of VAS, WOMAC and HAQ score in Group B (VS with LWI)

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Table 4: Comparison of VAS, WOMAC and HAQ score between group A (VS only) and Group B (VS with LWI)

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  Discussion Top


In the current scenario, scientific communities are not unanimous on the efficacy or applicability of either VS or LWI in clinical practice. There are differences of opinion on almost all aspects ranging from molecular weight of hyaluronic acid and duration of efficacy to clinical parameter affected. Unfortunately, there is also insufficient evidence to reject the potential of VS and LWI as treatment options of OA. The guidelines and position papers published by larger peer group societies across specialties such as orthopedics/rheumatology and across geographies, also significantly differ in their opinion.

AAOS guidelines for VS are “strongly not recommended” and for LWI it is “moderately recommended.”[4] Osteoarthritis Research Society International says that biomechanical interventions are appropriate for use in nonpharmacological treatment of OA knee, while for intra-articular HA, their recommendation is uncertain.[13] The European League Against Rheumatism recommends that intra-articular HA probably effective in knee OA and LWI can be used as one of the nonpharmacological treatment options.[14] ACR have no recommendation regarding the VS and LWI (no recommendation, weak/conditional recommendation, means it should not be used for the management purpose)[15] but a position paper issued by them recommends that HA may still be considered as a treatment option for OA of the knee.[16] In the presence of such difference in outcomes, it will always remain a challenge for the practicing clinician to follow any particular line of treatment.

We have tried to move forward in research to study if two different modes of treatment and having a different mechanism of action offers any better results that is, to see if they offer any synergy in their patient outcomes. We have used VS, which acts through biochemical and cellular mechanisms (improving the viscoelastic properties of SF, decreasing the degenerative process of the articular cartilage, and decreasing the inflammatory changes in the knee) and LWI, which act via altering the biomechanics of knee. It is hoped that such investigation can help in further removing the confusion over these treatment options. It is also significant to mention that it is first of such kind of study in published literature. There are no published works with similar structure or similar objective.

Our first group, treated with only VS, showed significant improvement at 2, 4, and 12 weeks follow-up in all three parameter assessed (pain using VAS, function in WOMAC and quality of life in HAQ). Pain is universally assessed parameter in all studies and most rely on using VAS. Our outcomes on pain are similar to many studies.[10],[17] Comparing HA with placebo only two studies[18],[19] show no significant improvement in pain. The outcomes of total WOMAC score (pain, stiffness, and difficulty in performing daily activities) which improved on follow-up and match many of previous studies[20],[21],[22],[23] but not consistent with some studies.[18],[19],[24] We have additionally included HAQ in our study to reflect the benefit, if any, on the overall quality of life. No other study in our literature search has assessed quality of life. HAQ also shows significant improvement on follow-up at 2, 4, and 12 weeks. As to the duration of benefit of treatment, the study by Bannuru et al.[25] shows that intra-articular HA shows significant improvement at 4 weeks with peak at 8 weeks and residual effect up to 24 weeks. In our study, subjects show continued improvement at 12 weeks but not followed beyond that due to limitation of study design.

The results of second group, consisting combined treatment of VS with LWI, also showed significant improvement at 2, 4, and 12 weeks' follow-up in comparison to baseline in all the three parameters.

On comparing the groups, there were no significant differences in terms of VAS and HAQ scores at all stages, while WOMAC score show significant difference at 2 and 4 weeks in favor of Group B (VS with LWI) but became insignificant at 12 weeks. This means adding LWI to VS showed better improvement in stiffness and function initially but it was not maintained for long term. Patients in both the groups showed similar improvement in pain but no additional advantage in Group B. Although initially the functional improvement was more in VS with LWI group but the same was not reflected in overall quality of life improvement as assessed by HAQ. This may be due to patients had developed a habit which could only be changed if proper lifestyle improving training were given. We did give some education but training for improvement in activities of daily living was not given. In the previous literatures, LWI was never combined with VS. In most of the studies, comparing LWI with placebo, it has been shown that LWI changes the biomechanical forces at knee, which causes unloading of medial compartment but there were no significant changes in WOMAC and other scores.[26],[27],[28]

The study has its own limitations. First, we did not have a placebo group or an isolated LWI group due to time constraint for this thesis work. Second, the reliability of compliance of LWI use by patients was purely dependent on patients reported data. Training for improvement in activities of daily living was not done.


  Conclusions Top


The result of this research concludes that VS has significant role in OA knee management. A single dose high molecular weight hyaluronic acid injection improves significantly the pain, function, and quality of life of moderate grade OA knee patients. In this study, the addition of LWI in the treatment gave initial relief in stiffness and function but not on subjective pain felt or on quality of life. Furthermore, in long-term, it had no added advantage over VS. A structured training of changing the habits formed over the years is essential for overall improvement in the quality of life. Future studies with larger subjects, multicenter involvement with placebo comparison are required for further optimization of results.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflict of interest.



 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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