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Journal of Back and Musculoskeletal Rehabilitation 27 (2014) 521–529 DOI 10.3233/BMR-140476 IOS Press

Effectiveness of massage therapy as co-adjuvant treatment to exercise in osteoarthritis of the knee: A randomized control trial Virginia Cortés Godoy∗, Tomás Gallego Izquierdo, Irene Lázaro Navas and Daniel Pecos Martín Department of Physical Therapy, University of Alcalá, Alcalá de Henares, Madrid, Spain

Abstract. BACKGROUND: The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee (KOA) is widely evidenced. The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA. METHODS: A blind, randomized controlled trial design was used. Eighteen women were randomly allocated to two different groups. Group A was treated with massage therapy and an exercise program, and Group B was treated with the exercise program alone. The intervention lasted for 6 weeks. Outcomes were assessed using a verbal analogue scale (VAS), the WOMAC index, and the Get-Up and Go test. Baseline, post-treatment, and 1- and 3-month follow-up data were collected. Values were considered statistically significant at a p < 0.05. The Mann-Whitney U test was applied in order to find out the differences between groups, and to verify the existence of such differences, the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out. RESULTS: In both groups, significant differences were found in the three variables between the baseline measurement and three months after treatment, with the exception of the WOMAC variable in group B (p = 0.064) No significant differences were found between both groups in the WOMAC index (p = 0.508) and VAS (p = 0.964) variables and the Get-Up and Go test (p = 0.691). CONCLUSION: Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA. The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects. Keywords: Knee osteoarthritis, exercise therapy, massage therapy, adults

1. Introduction Clinically significant knee osteoarthritis (KOA) is a common occurrence within the adult population. According to Spanish research (EPISER 2000), KOA has a prevalence of 10.2%, increasing up to 33.7% on women > 70 years of age [1]. ∗ Corresponding author: Virginia Cortés Godoy, Avenida de la Libertad, n◦ 15, 06800, Mérida, Spain. Tel.: +34 609574006; E-mail: [email protected]

KOA is characterized by a progressive breakdown of the knee diarthrodial cartilage. KOA may also affect the subchondral bone, the joint capsule, or the synovial membrane [2], causing knee pain and significant functional impairment concerning Daily Living Activities (DLAs) [3,4]. Consequently, the main objectives of using physical therapy in the treatment of KOA include: pain relief, improvement in function, and decreased deformity and joint instability [5,6]. Until 1990, it was thought that rest facilitated cartilage regeneration, while exercise could cause joint damage [7]. However, researchers and physicians cur-

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rently consider physical exercise to be a safe and effective treatment that should be recommended and frequently used [2,4,8–10]. After having broadly evidenced the benefits of exercise therapy in meaningful KOA, a development of long-term strategies is required [2,11,12]. Some interventions in the treatment of KOA are not as wellevidenced, such as massage therapy [5,11,13–15]. Massage Therapy can relieve the symptoms of KOA due to an increase in local blood circulation in the affected muscles, an improvement in muscle tone and flexibility, and an increase in pain threshold due to endorphin release [16]. Besides, the interaction between the therapist and the patient may benefit and have a positive influence on the patient’s state of mind [14]. Jamtvedt et al. [17] assessed the treatment of patients with KOA performed by 297 physical therapists, 30% of whom used massage therapy in > 80% of sessions despite little evidence of its results. The limited number of randomized control trials (RCTs) included in current systematic reviews [13,19] proves the scarcity of references. There are underdefined RCTs involving full-length Swedish massage therapy, myofascial release technique or manual therapy treatment that have produced unconfirmed results [13,18,19]. Massage therapy should be considered as a treatment option for KOA. The aim of the current study was to evaluate the effectiveness of massage therapy in the treatment of KOA. Furthermore, massage therapy could be used as co-adjuvant treatment to exercise therapy [11].

2. Materials and methods 2.1. Design A randomized, blind, pilot study which was approved by the Clinical Research Ethics Committee of Health Area Number Nine of the Autonomous Community of Madrid (Spain) was conducted. The intervention was carried out between October 2011 and June 2012. 2.2. Subjects Patients with a medical diagnosis of KOA, 67– 91 years of age, were recruited from an Elderly Home Care in Madrid and an Adult Day Care Centre in Madrid The selection was made using nonprobabilistic (convenience) sampling, according to the following criteria [3,9,10,20]:

Inclusion criteria: – Knee pain most days within the last month. – Disabling knee pain during at least one of the following activities: going down stairs or up stairs; walking at a pace of 0.4 km; and standing up or sitting down on the toilet or bed. – Radiologic evidence and/or clinical signs of KOA. No changes in drug administration, including NSAIDs, during the study Exclusion Criteria: – Rheumatoid arthritis or other inflammatory joint disease. – Surgery of the affected knee within the last year. – Intra-articular injection within the last 6 months. – Cognitive impairment that may bias the research. Finally, eighteen women were recruited for this study who voluntarily agreed to participate. They received information regarding the general goals of the study and signed the written informed consent. 2.3. Independent variables The primary independent variable was type of treatment applied, and it was divided into Treatment A (massage therapy + exercise program) and Treatment B (exercise program). Another independent variable was time. 2.4. Output variable and measures The primary dependent or output variables assessed in the current research were pain, functionality, and stiffness. The secondary dependent variables were agility, dynamic balance, and lower limb strength. Also, confounding or control variables such as body mass index (BMI; weight in kg/height in m2 ) and technical aids used by the patients (none, cane or walker) were taken into account. In order to objectify the previously mentioned output-variable results, the following measures were used: – Western Ontario and McMaster Universities Arthritis (WOMAC) index: broadly evidenced [21] and revised for use in the Spanish repeated word (Internal consistency yielded a Cronbach’s alpha ranging from 0.81 to 0.93) [22]; the higher the score, the more pain, stiffness, and functional impairment there is. – Verbal analogue scale (VAS): evaluates pain intensity, with 0 representing absence of pain and 10 representing the maximum possible pain.

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Fig. 1. Muscle stripping. (Colours are visible in the online version of the article; http://dx.doi.org/10.3233/BMR-140476)

– Get-Up and Go Test: a reliable and revised test [23] that assesses the secondary variables (agility, dynamic balance, and lower limb strength). In order to carry it out, a stool and a cone are required (2.44 m apart), the patient is asked to get up, reach the cone, walk around it, and sit down, and the time was measured using a handheld stopwatch; patients were permitted to take the test twice, and the best time was recorded. 2.5. Methods Randomized allocation followed this procedure: as patients arrived on the first day, they took one of the opaque, sealed envelopes that had been placed inside a ballot box, previously organized according to the random allocation established by the statistical packet Epidat 3.1. After each patient randomly picked their envelope, they opened it and found a sealed card inside that contained the allocation code A or B. The randomized allocation cards, as well as the opaque envelopes, were prepared and sealed by a person unaffiliated to the research study. – Group A or index group: massage therapy + lower limb exercise program – Group B or control group: lower limb exercise program only The massage-therapy strokes used in Group A were pressure, muscle stripping (performed with the tip of the thumbs; Fig. 1), and kneading. Massage-therapy strokes were applied to the different heads of the

Fig. 2. Exercise 1. (Colours are visible in the online version of the article; http://dx.doi.org/10.3233/BMR-140476)

quadriceps (over 5 minutes) and to the hamstring muscles (over 5 additional minutes). Both groups were instructed in a lower limb exercise program. The program consisted of different types of exercises [7], as follows: – Stretching, range of motion, and muscle-strengthening exercises [10]: ∗ Exercise 1: increasing flexibility by knee joint capsule-stretching exercise; patient in a sitting, non-weight bearing position (Fig. 2) The patient sat on the edge of the stretcher, with the knees bent at a right angle off the edge of the stretcher; the feet did not touch the ground, with a 1-kilo ankle weight on the affected leg; the patient stayed in this position for 5 minutes. ∗ Exercise 2: Knee joint last degree extension exercise in the supine position With the patient in the supine position, a wedge was placed under the affected knee so it was higher than the hip; the patient had a 30 degree bend in the knee, and tried not to rotate the leg with the toes pointing upwards; the patient gently pushed the wedge with the leg until the knee was fully extended (starting at a 30 degree bend in the knee) by tightening the quadriceps; the patient completed 10 repetitions, holding the final position for 5 seconds each. ∗ Exercise 3: Extension raising exercise

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(a) Exercise 2

Fig. 4. Flow chart of the subjects included in this study. (Colours are visible in the online version of the article; http://dx.doi.org/10.3233/ BMR-140476)

2.6. Statistical analysis

(b) Exercise 3 Fig. 3. a) Exercise 2; b) Exercise 3. (Colours are visible in the online version of the article; http://dx.doi.org/10.3233/BMR-140476)

In the supine position, the patient raised the affected leg to a completely straight position (40 degree bend in the hip), held the position for 5 seconds, then slowly lowered the leg; the patient completed 10 repetitions in each session. Exercises 2 and 3 are shown in Fig. 3. – Aerobic exercises: 5-minute sitting pedal exercise and 10-minute walking Both groups received individual treatment twice a week for 6 weeks. Both group outcomes were measured at baseline (before starting the treatment), posttreatment (just after completing the treatment), and at 1- (first follow-up) and 3-month (last follow-up) follow-up evaluations. To avoid biased information, the physical therapist who collected data was blinded. He took notes of all four measurements and collected the data on a personal exploration sheet with each patient’s code.

The data obtained were analyzed using the statistical package SPSS 22. The nature of the evaluated hypothesis was determined to be bilateral. The values p < 0.05 were considered to have statistical significance in an intention-to-treat analysis. The differences between the baseline measurement and the post-treatment measurement were then calculated for each of our dependent variables, the verbal numeric scale, the WOMAC Questionnaire and the Get Up and Go Test. The Shapiro-Wilk test was used to study the normality of the included variables, observing the differences between measurements and considering each treatment group in isolation. We observed that, depending on the measurement, some variables were normal, some were not, and in other cases the null hypothesis could not be rejected. Nonetheless, due to the small size of the sample (18 women, 9 in each group) non-parametric tests were carried out. The median and the first and third quartiles for all variables are shown in the descriptive statistical analysis of our data. Then, we tested the homogeneity of both treatment groups regarding the variables “age”, “BMI”, “use of technical aid”, “arterial hypertension” and “pretreatment measurement of dependent variables”. In order to check such homogeneity we have used the Mann-Whitney U Test, except for the variable “use of

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Fig. 5. Technical aids. (Colours are visible in the online version of the article; http://dx.doi.org/10.3233/BMR-140476)

technical aid”, for which the Fisher’s exact test was used. After that, the values obtained from our dependent variables were compared in all four measurements (pre-treatment, post-treatment, one month after treatment and three months after); this analysis was carried out independently for each of the treatment groups. The repeated measurements Friedman test was used, supplemented by multiple comparisons tests. Last, we contrasted the efficacy of both treatment groups, comparing the values of the variables “difference pre-treatment/post-treatment” and “difference pre-treatment/three-month follow up”, using the MannWhitney U Test.

3. Results This study sample is made up of 18 patients (Fig. 4), allocated into two groups of 9 subjects each; during the development of the study, group A lost one patient, which has been included in the intention-to-treat data analysis. The different technical aids used by subjects in each group are shown in Fig. 5. In Table 1 we can observe the baseline descriptive data of the patients in each group: age, BMI, use of technical aids, arterial hypertension and pretreatment dependent variables. We also included the non-existence of significant differences between both groups in those variables. – Analysis of the differences between measurements The Friedman ANOVA Test, supplemented by multiple comparisons tests, was used in order to determine if there were changes between the different measurements carried out in each of the response variables, considering each group in isolation. The results ob-

tained regarding pain, stiffness and functionality show that there were differences in the three response variables evaluated and in the four measurements carried out in each group. These results are shown in Table 2. In both groups, we have found significant differences in the three variables between the baseline measurement and three months after treatment, except for the variable “WOMAC” in group B, where a descriptive difference can be observed, but it is not statistically significant. However, we have observed a significant difference in group A between the baseline measurement and the post-treatment in the variable “WOMAC”. In this group we have also come across a non-statistically significant descriptive difference between the baseline measurement and the one carried out one month after treatment in that same variable. Apart from the aforementioned differences found in group B, significant differences were also observed in the following variables: “WOMAC”, between the baseline measurement and after one month; “VAS”, between the baseline measurement and post-treatment and “Get Up and Go Test”, between the baseline measurement and at one month. After contrasting the differences between group A and group B, as shown in Table 3, no significant differences were found between both treatment groups in any case.

4. Discussion The outcomes measured in this research were not sufficient to prove the existence of significant differences between Treatment A (massage therapy + exercise program) and Treatment B (exercise program) for any of the output variables. These outcomes endorsed those of Jamtvedt et al. [13], who reported that manual therapy is not more effective than any other conventional treatment for KOA.

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Table 1 Pre-treatment descriptive data. For the variables “age”, “BMI”, “WOMAC”, “ENV” and Get Up and Go Test the median, the first and third quartile and the p-value of the Mann-Whitney U Test are shown. For the variables “use of technical aids”, we include the absolute frequency of each category together with their corresponding percentage and Fisher’s exact Test p-value Age BMI Total WOMAC VAS Get Up and Go Use of technical aids

Median (first and third quartiles) Mann-Whitney U test Median (first and third quartiles) Mann-Whitney U test Median (first and third quartiles) Mann-Whitney U test Median (first and third quartiles) Mann-Whitney U test Median (first and third quartiles) Mann-Whitney U test Absolute frequency (percentage) Fisher’s Exact Test

Group A (n = 9) 85.00 (81.00–89.00)

Group B (n = 9) 84.00 (82.00–84.50) p = 0.474

27.20 (25.75–30.20)

24.10 (23.05–30.40) p = 0.112

41.81 (33.31–52.84)

30.31 (19.37–40.98) p = 0.077

5.00 (4.50–6.00)

2.00 (1.50–7.00) p = 0.222

26.10 (12.90–30.00)

15.80 (9.70–26.35) p = 0.222 Yes 6 (66.7%) No 3 (33.3%) Yes 5 (55.6%) No 4 (44.4%) p = 1.000

Table 2 Comparison of the measurements carried out for each of the response variables, considering each treatment group in isolation Baseline TOTAL WOMAC

Median (first and third quartile)

41.81 (33.31– 52.84)

Friedman ANOVA Baseline/Post-treatment Baseline/At one month Baseline/At 3 months Post-treatment/At one month Post-treatment – At 3 months At 1 month/At 3 months VAS

Median (first and third quartiles)

Median (first and third quartiles) Friedman ANOVA Basaline/Post-treatment Baseline – At one month Baseline – At 3 months Post-treatment/At 1 month Post-treatment/At 3 months At one month – At 3 months

At 3 months 29.77 (22.85– 31.46)

Basal treatment 30.31 (19.37– 40.98)

Group B (n = 9) PostAt 1 month 3 months 17.47 10.20 (6.73– (6.09– 37.46) 26.73) p = 0.012 p = 0.268 p = 0.011 p = 0.064 p = 1.000 p = 1.000 p = 1.000

At 15.73 (9.60– 26.86)

5.00 (4.50– 6.00)

3.57 4.10 (3.00– (1.75– 4.50) 5.50) p = 0.006 p = 0.082 p = 1.000 p = 0.021 p = 1.000 p = 1.000 p = 0.497

3.28 (2.50– 4.00)

2.00 (1.50– 7.00)

1.00 1.00 (0.00– (0.00– 3.00) 3.50) p = 0.001 p = 0.049 p = 0.135 p = 0.011 p = 1.000 p = 1.000 p = 1.000

1.00 (0.00– 2.69)

26.10 (12.90– 30.00)

17.17 17.01 (9.85– (10.45– 21.78) 22.65) p = 0.040 p = 0.407 p = 0.724 p = 0.028 p = 1.000 p = 1.000 p = 1.000

15.40 (9.47– 20.98)

15.80 (9.70– 26.35)

10.60 13.07 (8.19– (7.35– 20.65) 18.35) p = 0.006 p = 0.106 p = 0.006 p = 0.037 p = 1.000 p = 1.000 p = 1.000

12.56 (7.32– 17.55)

Friedman ANOVA Baseline/Post-treatment Baseline/At un mes Baseline/At 3 months Post-treatment/At one month Post-treatment/At 3 months At 1 month/At 3 months Get up and Go

Group A (n = 9) PostAt treatment 1 month 28.23 31.62 (21.09– (24.26– 36.60) 36.57) p = 0.008 p = 0.021 p = 0.064 p = 0.021 p = 1.000 p = 1.000 p = 1.000

However, there are non-significant differences for Group A between the median scores at the beginning and the end of treatment following the WOMAC index and Get-Up and Go test. This corresponds with a greater decrease in pain and stiffness and better func-

tionality for Group A patients, and was clinically relevant. This can also be applied to pain perception measurement, where the same decrease in the median can be observed in both groups (1.7 points).

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Table 3 Contrast of differences between both groups between baseline and post-treatment measurements and between baseline and after three months measurements WOMAC TOTAL

Group A Baseline/Post-treatment Difference Median (first and third quartiles)

Group B 16.75 (6.46–21.62)

p = 0.508

Mann-Whitney U test Baseline/At 3 months Difference Median (first and third quartiles)

15.23 (1.50–26.16)

Baseline/Post-treatment Difference Median (first and third quartiles)

2.00 (0.71–2.50)

2.00 (1.36–2.86)

Baseline/Post-treatment Difference Median (first and third quartiles) Mann-Whitney U test Baseline/At 3 months Difference Median (first and third quartiles) Mann-Whitney U test

Along with the references consulted, this decrease can be considered clinically relevant [18,19]. The absence of a difference between groups may be related to the sample size. In that case, larger sizesample research is recommended. These outcomes endorsed those of the systematic review by French et al. [18], who reported the positive effect of massage therapy as co-adjuvant treatment for KOA. It would be convenient to design clinical trials to validate the differences between groups. As a consequence, the clinical relevance of massage therapy in KOA could be confirmed. Perlman et al. [14,15] reported the effectiveness of massage therapy showing significant differences for the index group. As the number of sessions was similar to the number of sessions in the present research, this effectiveness may be a consequence of the duration of the massage (1 hour compared to 10 minutes in the present research). In addition, the massage protocols applied were different in each research. Perlman et al. [15] applied Swiss massage in several body parts, while in the present research massage was only applied to hamstring muscles and the quadriceps.

2.00 (1.00–3.50)

p = 0.964

Mann-Whitney U test Get up and Go

2.00 (0.50–2.50)

p = 0.784

Mann-Whitney U test Baseline/At 3 months Difference Median (first and third quartiles)

11.34 (7.47–19.84)

p = 0.965

Mann-Whitney U Test VAS

11.33 (5.65–17.72)

4.20 (1.70–10.66)

3.30 (0.41–8.08)

p = 0.354 7.60 (−0.70–12.80)

4.00 (0.27–9.87)

p = 0.691

For a correct interpretation of the results, it is important to mention that baseline data were more unfavourable for Group A than Group B. Specifically, the median scores for age and BMI were higher for Group A, and there were more patients who used technical aids for walking in this group (Table 1 and Fig. 5). However, these baseline differences between groups were not significant. For future investigations, the baseline differences between groups should be controlled in order to avoid bias. Data analysis showed significant differences between the beginning and the end of the intervention without considering group allocation, suggesting that both groups received beneficial treatment for KOA management. Differences were still significant between the baseline and 3-month follow-up assessments, indicating that beneficial effects disregarding group allocation continued through time (3 months), as shown in Fig. 6. Future investigations should prove if a 6-week, twice-a-week protocol would be sufficient to achieve beneficial effects regarding pain, functionality, stiff-

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36.86

24.65

24.94

23.98

Total WOMAC

20.28

4.44

Pre-Treatment

VAS

15.68

15.04

2.66

2.55

Post-Treatment

14.32

Get-Up and Go Test

2.33

1 Month

3 Months

Time

Fig. 6. Output-variable means evolution. (Colours are visible in the online version of the article; http://dx.doi.org/10.3233/BMR-140476)

ness, dynamic balance, and lower limb strength in patients with KOA. In short, the limitations found during the intervention were as follows: – The lack of statistical significance does not imply that, in reality, there is no relevant association between the study factor and the response. As it was our case, this absence of differences between treatments could be due to the fact that the number of people analysed may have been insufficient, and therefore, the statistical power could not detect those possible differences. – One of the goals of our study is to confirm the causal relationship between the study factor and the response variable. The fact that the subjects are only women within a specific age range (67– 91 years) makes for a highly homogeneous sample and it could differ from the real population, so the results may not be generalized or extrapolated. – The sample selection, which was representative of the study population, was carried out through non-probabilistic sampling, and this could mean that the obtained variable estimation may differ from its real value. – The follow-up period lasted 3 months; this period of time should be increased in future investigations to assess longer-term effectiveness As a result, better external validity, a proper sample size, and a longer follow-up period are suggested for future investigations given the chronicity of KOA. Similarly, the sample should include male and female subjects in order to increase heterogeneity that allows probabilistic sampling, which would increase the internal validity of the study. This would lead to solid evidence that shows the effectiveness of massage therapy for KOA management.

5. Conclusions – Comment 16: According to the results of this study no significant differences were found between both treatment groups, therefore the incorporation of massage to the exercise program is not relevant in the treatment of KOA. – Although not significant, differences between the different-group mean scores at the beginning and end of treatment for Group A have been registered following the WOMAC index and Get-Up and Go test. – As differences in all both-group variables were shown, these treatments may not have any beneficial effect on KOA management.

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Effectiveness of massage therapy as co-adjuvant treatment to exercise in osteoarthritis of the knee: a randomized control trial.

The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee (KOA) is widely evidenced. The current study aims to compare the ...
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