The Effect of Modifying the Sitting and Getting up Method on Pain Intensity in Patients with Pes anserine tendinitis bursitis: A Randomized Clinical Trial Study

doi:10.21203/rs.3.rs-2858759/v1

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The Effect of Modifying the Sitting and Getting up Method on Pain Intensity in Patients with Pes anserine tendinitis bursitis: A Randomized Clinical Trial Study

https://doi.org/10.21203/rs.3.rs-2858759/v1

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Background: The aim of this study was to determine the effect of modifying the sitting and getting up method on pain intensity in patients with Pes anserine tendinitis bursitis (PATB).

Methods: This randomized clinical trial study was conducted on 60 patients with PATB who referred to the rheumatology clinic of Semnan city (Iran) in 2020. The sampling method was convenience and eligible patients divided into two groups using a random number table (intervention group, n=30; control group, n=30). First, both groups were advised to lose weight and not to sit on two knees and cross-legged and strengthen the quadriceps muscle by lying on the flat surface for 3 seconds, repeating 30 times and 3 times a day. Then, the rheumatologist taught the intervention group to modify the sitting and getting up method in such a way that the leg is placed in a position where the tibia is in a neutral position and does not rotate outward. However, for the control group, only periodic examinations were performed. Finally, the severity of the knee pain based on visual analog scale (VAS) was measured 8 weeks after intervention for two groups. The data were analyzed using SPSS 24 software and P-Value <0.05 was considered as a significant level.

Results: There were no significant statistical difference between the two groups in terms of baseline variables (age, BMI, pain intensity, duration of osteoarthritis and duration of Pes anserine bursitis) before intervention (P-Value>0.05). However, Repeated Measure ANOVA test showed the mean of pain intensity in the intervention group is lower than the control group after intervention (P-Value<0.001).

Conclusions: This study suggests that modifying the sitting and getting up method can reduce pain intensity in patients with PATB. However, studies with a larger sample size are recommended.

pain intensity

Pes anserine tendinitis bursitis

sitting and getting up method

clinical trial study

The joint place of the semitendinosus, Sartorius and gracilis muscles in the anterior part of the tibia is called Pes anserine. Under this area, the bursa is located and its inflammation (bursitis) is one of the most common causes of pain caused by the soft tissue of the knee [1, 2]. Various studies have reported the incidence of Pes anserine tendinitis bursitis syndrome (PATBS) to be about 2.5 to 10% [3, 4]. Female gender, obesity, infection, flat feet and type 2 diabetes have been proposed as the most important risk factors for PATBS [5, 6]. This disease is also associated with rheumatoid arthritis and degenerative knee diseases, especially osteoarthritis, however, the etiology and pathogenesis are still not well understood [7]. The classic symptoms of PATBS include tenderness and inflammation of the medial proximal knee area, which can mimic the pain pattern of joint damage to the medial meniscus and collateral ligament [8].The diagnosis of PATB is based on clinical symptoms; so that the patient complains of pain when going up and down, getting up from a sitting or lying position, and even walking on flat surfaces [8, 9]. The most important clinical examination is the presence of tenderness when touching the medial proximal area of the tibia, which is 2 to 3 cm below the anteromedial area of the joint. Also, external rotation of the tibia and resistance to active rotation of the leg are painful [4, 10].

Although the administration of non-steroidal anti-inflammatory drugs (NSAIDs) and intra-bursal injections of local anesthetics or corticosteroids are among the suggested treatments, however, the response to treatment varies from 10 days to 36 months, depending on the treatment method and the individual's lifestyle [3, 11]. In addition, common and available treatments, especially injectable forms, may be associated with risks such as subcutaneous tissue atrophy, skin pallor and even tendon rupture, because about 30% of patients receiving oral and injectable treatments, their pain is not controlled and about 10% also suffer from treatment-related complications [7, 10].

It seems that modifying the patient's movements and lifestyle may help to prevent the exacerbation of the disease and even cure the person faster because the researcher of this study (rheumatologist) has concluded in her clinical observations that in PATB patients with a high body mass index, the tibia bone rotates outward when standing up from a sitting or lying position which this rotational pressure on the knee (external rotation) increases the incidence of disease and resistance to treatment. Hence, it may be possible to reduce the treatment-resistant cases by modifying the type of sitting and standing of patients, by placing the position of the lower limb in a position where the tibia is in a neutral position and does not rotate outwards. Therefore, the present study was designed and implemented with the aim of investigating the effect of modifying the sitting and getting up method on pain intensity in patients with PATB.

I. Study Design and Subjects

This randomized clinical trial study was conducted on 60 patients with medial knee pain complaint who referred to the rheumatology clinic of Semnan city (Iran) in 2020. The sampling method was convenience. Then, eligible patients divided into two groups using a random number table (intervention group, n = 30; control group, n = 30). Inclusion criteria included women in the age group of 50 to 60 years, BMI ≥ 25 kg/m2, suffering from Pes anserine tendinitis bursitis syndrome (PATBS) according to the Kellgren–Lawrence grading system, duration of Pes anserine bursitis ≥ 4 months and grade 2 or 3 osteoarthritis knee. Exclusion criteria included suffering from heart diseases, diabetes, hypertension, gastric and duodenum ulcers, various cancers, liver and kidney disorders, painkiller intolerance, history of knee surgery or inflammatory arthritis or trauma to the knee and previous PATB treatment during the last year.

II. Intervention

Before the study began, the research objectives were explained for the patients and informed consent was obtained from them. Then, patients with PATBS divided into two groups using a random number table (intervention group, n = 30; control group, n = 30). First, both groups were prescribed Naproxen (500 mg/12hr) or Diclofenac (75 mg/day Bi divided) and Pantoprazole (40 mg NPO in the morning) for 2 weeks. Also, both groups were advised to lose weight and not to sit on two knees and cross-legged and strengthen the quadriceps muscle by lying on the flat surface for 3 seconds, repeating 30 times and 3 times a day. In addition to the above, the rheumatologist taught the intervention group to modify the sitting and getting up method in such a way that the leg is placed in a position where the tibia is in a neutral position and does not rotate outward. However, for the control group, only periodic examinations were performed. The re-examination and careful examination of the tenderness of the bursitis area and the severity of the knee pain based on visual analog scale (VAS) were measured 8 weeks later for all the people in the two groups. Patients were asked not to take any additional analgesics during the study .The patient's companion was also asked to monitor the patient's sitting and standing method during 8 weeks. It should be mentioned, in order to ensure that the patient performs the exercises, the researcher contacted the patients of the intervention group every other day and followed up and controlled the training process.

III. Data Collection

The data collection tool was a checklist, including the demographic and clinical variables age, height, weight, body mass index (BMI), duration of osteoarthritis, duration of PATBS and pain intensity which was collected through interview and examination of the patient. VAS was also used to measure pain intensity.

IV. Statistical Analysis

In descriptive analysis, mean (S.D) and number (%) were used for quantitative variables. In analytical analysis, the independent-samples T-test (existence of normal distribution), Mann–Whitney U test (lack of normal distribution) to compare the quantitative variables in two group. Finally, Repeated Measure ANOVA test was used to compare the means of pain intensity at different time periods in the two groups of intervention and control. It should be noted that the data were analyzed using SPSS software (version 24.0) and P-Value < 0.05 was considered as a significant level.

V. Ethical Considerations

Before data collection, the aims of the research were explained to the participants, then informed consent was obtained from them. The protocol study was conducted according to the principles expressed in the Declaration of Helsinki and was approved by the Deputy of Research and Ethics Committee of Semnan University of Medical Sciences (ID-number: IR.SEMUMS.REC.1396.60). Additionally, this clinical trial study was registered in Iranian Registry of Clinical Trials (registration ID: IRCT2017031112823N4).

This clinical trial study was conducted on 60 patients with medial knee pain complaints. These patients were randomly divided into intervention (n = 30) and control groups (n = 30). Table 1 shows baseline characteristics in two groups of intervention and control. As can be seen, the mean (± S.D) age and BMI in the intervention and control groups were 55.37 (± 2.95) vs. 54.77 (± 3.16) years and 29.33 (± 2.34) vs. 29.02 (± 2.87) kg/m2; respectively. The mean (± S.D) duration of osteoarthritis in two groups was 2.80 (± 1.27) and 2.50 (± 0.51) years; respectively. Also, the mean (± S.D) duration of Pes anserine bursitis and pain intensity (according to VAS) was 4.03 (± 1.94) vs. 3.73 (± 1.91) years and 7.97 (± 1.37) vs. 7.93 (± 1.48); respectively.Generally, as can be seen, there were no significant statistical difference between the two groups under study in terms of baseline variables before intervention (P-Value > 0.05). This lack of significant statistical difference between the two groups can be a reason that randomization process has occurred correctly (Table 1).

Table 1

Comparison of baseline variables in two groups of intervention and control before the intervention
Variable	Group	N	Mean	S.D*	Min	Max	P-Value**
Age (year)	Intervention	30	55.37	2.95	51	60	0.450
Age (year)	Control	30	54.77	3.16	50	60	0.450
Weight (kg)	Intervention	30	75.07	6.01	65	77	0.621
Weight (kg)	Control	30	74.23	6.95	57	87	0.621
Height (cm)	Intervention	30	160.00	2.47	156	165	0.985
Height (cm)	Control	30	161.5	2.53	156	166	0.985
BMI (kg/m2)	Intervention	30	29.33	2.34	25.39	35.30	0.651
BMI (kg/m2)	Control	30	29.02	2.87	22.55	32.87	0.651
(year) Duration of osteoarthritis	Intervention	30	2.80	1.27	2	9	0.235
(year) Duration of osteoarthritis	Control	30	2.50	0.51	2	3	0.235
Duration of Pes anserine bursitis (year)	Intervention	30	4.03	1.94	1	8	0.548
Duration of Pes anserine bursitis (year)	Control	30	3.73	1.91	1	7	0.548
Pain intensity according to VAS	Intervention	30	7.97	1.37	5	10	0.928
Pain intensity according to VAS	Control	30	7.93	1.48	5	0	0.928
: standard deviation * : Independent Samples t-Test

Then, Repeated Measure ANOVA test was used to compare the mean of pain intensity between the two groups of intervention and control at different time periods, which, the results of the test showed a significant statistical difference between the two groups of intervention and control in terms of pain intensity at different time periods (P-Value < 0.05); so that, the mean of pain intensity in the intervention group was lower than the control group after intervention (Table 2). Figure 1 also shows this decrease in pain intensity in the intervention group compared to the control group.

Table 2

Comparison of the means pain intensity at different time periods in intervention and control groups
Pain intensity according to VAS	Group	N	Mean	S.D*	P-Value**
T1: before intervention	Intervention	30	7.97	1.37	< 0.001
T1: before intervention	Control	30	7.93	1.48
T2 : after intervention	Intervention	30	2.30	1.15
T2 : after intervention	Control	30	5.00	2.92
*P-Value : Significant Level for Interaction Group and Time by Repeated Measure ANOVA Test

Based on our knowledge, the present study is one of the first studies that investigated the effect of modifying the sitting and getting up method on pain intensity in patients with PATB during a randomized clinical trial study. The results of data analysis showed that the two groups did not have a statistically significant difference before the intervention in terms of baseline variables age, BMI, pain intensity, duration of osteoarthritis and duration of Pes anserine bursitis, which indicates the correct implementation of random allocation. However, a statistically significant difference was observed between the two groups in terms of pain intensity; so that, the mean of pain intensity in the intervention group was lower than the control group after intervention, in other words, modification of the sitting and getting up method (placing the leg in a position where the tibia is in a neutral position and does not rotate outward) caused a greater reduction in pain intensity in the intervention group than in the control group.

In line with the results of the present study, some studies have shown that lifestyle modification along with muscle strengthening exercises can reduce pain and activity limitation in patients with knee osteoarthritis [12, 13]. For example, in a study conducted by Jasmijn et al., a significant relationship was observed between modification of movement behaviors, physical activity and better knee function in adults with knee osteoarthritis [13]. Other studies have also stated that excessive knee adduction torque accelerates the progression of knee osteoarthritis and has a direct relationship with the severity of pain in affected people. This is the issue that is emphasized to be corrected to reduce pain intensity in these studies, because reducing the walking speed and increasing the thigh abduction internal torque during the middle and last stages of standing is one of the most important strategies that people with knee osteoarthritis use to reduce pain. In addition, people with knee osteoarthritis often perform compensatory walking patterns such as increasing trunk lateral bending in response to chronic pain and structural damage and to reduce the load on the knee joint that the weakness of thigh abductor muscles may be the reason for using such strategies. Although the compensatory patterns of sitting, standing and walking may reduce the load on the knee joint, reduce the need for thigh abductor muscles and eventually weaken these muscles in the long term, however, generalized weakness of all hip muscles may occur due to decreased activity levels associated with knee osteoarthritis [14, 15]. Also, in a review study by Allyn M Susko et al. aimed to determine the role of therapeutic exercise in the management of knee osteoarthritis pain, exercise was strongly suggested as one of the most important options for reducing pain in knee osteoarthritis sufferers, however, the optimal mode and dosage of exercise have not been determined exactly. In addition, it is not clear through what mechanism (peripheral or central or combined mechanisms) causes pain intensity reduction [16].

On the other hand, the evidence indicates that interleukin 1 beta (IL-1β) causes the release of prostaglandins and nitric oxide in the arthritic joint, which can ultimately lead to a decrease in proteoglycan synthesis and a decrease in extracellular cartilage matrix. Chowdhury et al have suggested that dynamic compression of chondrocytes leads to a decrease in the synthesis of prostaglandins and a decrease in nitric oxide levels. This compression can occur during exercise therapy in patients with osteoarthritis of the knee, which imposes a physiological and dynamic load on the knee joint [17].

In addition to osteoarthritis, modification of movement behaviors to reduce pain intensity in other diseases has also been tested and confirmed. For example, in a study conducted by Ebrahimi et al. with the aim of investigating the electromyographic behavior of trunk muscles during prolonged load holding in subjects with hyperlordotic posture and normal subjects, the results showed that increasing the lumbar arch has significantly changed the activity level of the trunk muscles in people with hyperlordosis compared to the normal group and finally, these researchers concluded that the use of posture correction exercises in the treatment program of such people seems necessary [18].

Studies have shown that physical activity can reduce the excitability of the motor cortex and ultimately reduce the intensity of pain by causing a decrease in motor evoked potential. This problem shows that it is possible to reduce the intensity of pain regardless of how the exercise is performed [19]. In this regard, a clinical trial study by Nicola J. Stagg on rats showed that regular aerobic exercise can improve neuropathic pain symptoms and help reduce pain by increasing the level of opioid content in brainstem regions. Finally, the researchers of this study suggested exercise as an important factor in reducing central sensitization and finally reducing pain [20]. In addition to animal studies, human studies have also supported the role of exercise as a factor in immediate pain relief in areas distal to the affected area [21, 22]. For example, in a clinical trial study by Martin D Hoffman et al. on patients with chronic low back pain, the results indicated that aerobic exercise with cycling could reduce the perception of pressure pain for more than 30 minutes after exercise in these patients, which it can indicate a decrease in central sensitization [21].

This study has limitations and strengths. Perhaps the most important strength of this study is its implementation in the form of a randomized clinical trial study with two groups with equal sample size. It is also among the first studies that have been conducted in this field. The most important limitation may be the relatively low sample size, so to solve this problem, multicenter clinical trial studies with high sample size are recommended.

This study suggests that modifying the sitting and getting up method can reduce pain intensity in patients with PATB. However, studies with a larger sample size are recommended.

PATB

Pes anserine tendinitis bursitis

BMI

body mass index

VAS

visual analog scale

NSAIDs

non-steroidal anti-inflammatory drugs

S.D

standard deviation

IL-1β

interleukin 1 beta

Acknowledgements

This article is extracted from Marjan Moazeni’s thesis of doctor of general medicine in School of Medicine, Semnan University of Medical Sciences.

Authors’ contributions
JM , EGH and MM conceived the study, collected data and performed statistical analysis. MM and JM participated in the study design, drafted the manuscript and contributed to data analysis. JM , EGH and MM helped to draft the manuscript and revised it critically. All authors read and approved the final manuscript.

Funding

This study was funded by Semnan University of Medical Sciences, Semnan, Iran.

Availability of data and materials

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Ethics approval and consent to participate

Before data collection, the aims of the research were explained to the participants, then informed consent was obtained from them. The protocol study was conducted according to the principles expressed in the Declaration of Helsinki and was approved by the Deputy of Research and EthicsCommittee of Semnan University of Medical Sciences(ID-number: IR.SEMUMS.REC.1396.60). Additionally, this clinical trial study was registered in Iranian Registry of Clinical Trials (registration ID: IRCT2017031112823N4).

Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.

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No competing interests reported.

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The Effect of Modifying the Sitting and Getting up Method on Pain Intensity in Patients with Pes anserine tendinitis bursitis: A Randomized Clinical Trial Study

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Version 1

Abstract

Figures

Background

Methods

I. Study Design and Subjects

II. Intervention

III. Data Collection

IV. Statistical Analysis

V. Ethical Considerations

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Additional Declarations

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