Effect of low-magnitude, variable-frequency vibration therapy on pain threshold levels and mobility in adults with moderate knee osteoarthritis - randomized controlled trial

doi:10.21203/rs.3.rs-2132492/v1

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Research Article

Effect of low-magnitude, variable-frequency vibration therapy on pain threshold levels and mobility in adults with moderate knee osteoarthritis - randomized controlled trial

https://doi.org/10.21203/rs.3.rs-2132492/v1

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Journal Publication

published 13 Apr, 2023

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Background: Osteoarthritis (OA) is one of the most commonly recorded diseases in clinical practice. Vibration therapy has been suggested for the treatment of knee OA. The purpose of the study was to determine the impact of vibrations of variable frequency and low amplitude on pain perception and mobility in patients suffering from knee OA.

Methods: 32 participants were allocated into two groups – Group 1 (oscillatory cycloidal vibrotherapy-OCV) and Group 2 - control (sham therapy). The participants were diagnosed with moderate degenerative changes in the knee (grade II based on the Kellgren-Lawrence (KL) Grading Scale). Subjects received 15 sessions of vibration therapy and sham therapy respectively. Pain, range of motion, and functional disability were assessed through Visual Analog Scale (VAS), Laitinen questionnaire, goniometer (ROM – range of motion), timed up and go test (TUG) and Knee Injury and Osteoarthritis Outcome Score (KOOS). Measurements were taken at baseline, after the last session and four weeks after the last session (follow up). T-test and U-Mann Whitney test compare baseline characteristics. The Wilcoxon and ANOVA tests compared mean VAS, Laitinen, ROM, TUG and KOOS. The significant P-value was less than 0.05.

Results: After 3 weeks (15 sessions) of vibration therapy, reduced the sensation of pain and improved mobility was recorded. There was a more significant improvement in the vibration therapy group than the control group in pain alleviation on VAS scale (p <0.001), on Laitinen scale (p <0.001), knee ROMs flexions (p <0.001) and TUG (p <0.001) at the last session. KOOS score with pain indicator, symptoms, activities of daily living, function in sport and recreation and knee related quality of life improved more in the vibration therapy group than the control group. Effects maintained up to 4 weeks in vibration group. No adverse events were reported.

Conclusions: Our data demonstrated that the use of vibrations of variable frequency and low amplitude in patients with the knee OA is a safe and effective therapy. It is recommended to increase the number of treatments performed, primarily in patients with degeneration II° according to the KL classification.

Trial registration: Prospectively registered on ANZCTR (ACTRN12619000832178). Registered on 11 June 2019. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000832178

vibration

physical therapy modalities

osteoarthritis

knee

pain

VAS

ROM

Osteoarthritis (OA) is one of the most frequently recorded diseases in clinical practice [1]. It is the result of overlapping diseases of various kinds, which, despite their different aetiology, lead to analogous biological, morphological and clinical effects [2]. It is defined as one of the components of the natural ageing process of the body, resulting from the mechanical wear (abrasion) of the joint surfaces during physical activity. Therefore, age is one of the risk factors for osteoarthritis [3, 4, 5, 6]. The main cause of these changes is the imbalance between the processes of degeneration and regeneration of the articular cartilage and the subcartilage layer, including those which largely depend on enzymatic activity [7, 8]. These changes usually develop slowly and, worsening over time, inevitably lead to painful limitation of joint mobility, deformation and contracture, and limb axis distortion. It is registered more often in women than in men, and above all, after the age of 50. In people over 65 years of age, its morphology, course and clinical expression are also significantly influenced by involutional degenerative and hormonal changes that develop over time in the osteoarticular and nervous systems [5, 6, 7]. One of the many problems with osteoarthritis is the sensation of pain. Initially, it is associated with physical exertion (post-exercise pain), and with time it takes the form of night and rest symptoms [9]. It is also associated with posturographic and stabilometric changes [10, 11, 12]. The result is limited physical activity, which makes further treatment difficult. Vibrotherapy is indicated as one of the treatment regimens for OA. Such therapy is defined as a method of effective, non-pharmacological and inoperable treatment of patients with osteoarthritis of knee joints [13]. In the method, constant frequencies which are designed to improve the overall functioning of the muscular-ligament and joint apparatus are most often used locally [14]. Pamukoff et al. indicated. that the action of Local Muscle Vibration (LMV) and the Whole Body Vibration (WBV) significantly improved the function of the quadriceps muscle and may be useful methods of restoring its strength in people with degenerative changes of the knee joints [15]. Vibrotherapy in the treatment of degenerative joint changes is the method which is more and more often used both in the area of the whole body and locally at the site of the disease [14, 15, 16].

The aim of the study was to determine the effectiveness of vibratory stimulation on pain thresholds level, range of motion, and functional disability in OA patients. The study was conducted to summarize and determine the efficacy of vibration therapy of individuals with osteoarthritis. It was a single-blinded, controlled, two-group parallel design. Patients were allocated to either vibration therapy group or control group. The experimental subjects were osteoarthritis volunteers recruited from the physiotherapy clinics. They were informed of the purpose of the experimental procedures before the experiments commenced and that they could leave at any time. The study was approved by the Ethical Committee of Regional Medical Chamber in Cracow [Ref no. 120/KBL/OIL/2018].

Study Population

The study involved 32 people in total, divided into two groups. The sample size was determined by performing a priori power analysis. 16 patients were included in the treatment group. The control group also included 16 people. The age of those included in the study ranged from 42 to 79 years (mean 64.28 years), their mean body weight was 82.18 kg, and their body height was 1.62 meters. Advanced degenerative changes of the knee joints of the grade II were diagnosed in the patients included in the study based on the Kellgren-Lawrence scale [17]. The advancement of the degeneration was assessed by a specialist in the field of orthopaedics and traumatology of the musculoskeletal system. The knee joint, which was characterized by a higher degree of advancement of degenerative changes, was taken into account for the analysis.

Study Duration

The duration of the study was from January 2019 to May 2021.

Data Collection Procedure

The data collection was started after the approval from Institutional Review Board, Academy of Physical Education in Cracow. The recruitment of patients to participate in the presented studies lasted from 2019 to 2021 (from medical facilities in Nowy Sącz, Poland). Participants were assigned to the random numbers from random number tables to the treatment conditions. The block size was determined by the researcher and was multiple with two treatment groups. 32 patients enrolled in the study were divided into those who underwent therapy (the group that underwent vibrotherapy treatments) and those that were the control group (sham treatments). The study included people with no contraindications to vibrotherapy in accordance with the Instructions for Use of the RAM Vitberg + vibrotherapy apparatus (Vitberg + Rehabilitation Massage Unit; Vitberg, Poland); diagnosed with degenerative disease of the grade II according to the Kellgren-Lawrence scale with reference to at least one knee joint, lasting at least 4 years. The recruitment to the proposed study was based on medical qualifications, including available medical documentation (medical history, information sheets, outpatient treatment cards, including physiotherapy treatment cards). During the study, participants were asked not to change their eating habits, take the medications administered so far, not to change their current physical (recreational) activities, not to use any physiotherapeutic procedures except those administered during the study. The order of applications and the availability of patients determined the assignment to a group in a given round. The data was collected through questionnaires and measurements before initiating the first physiotherapy session for baseline comparison of both groups and after the last physiotherapy session. Then 4 weeks after the last session to get information about follow up period. The whole procedure for assessing outcomes has taken 8–16 minutes.

Masking

This study was a single-blinded controlled trial in which the patients were prevented from knowing the interventions assigned to them.

Intervention

Vibration therapy was provided by the medical device - RAM Vitberg + Base Module and RAM Vitberg + Knee Module (Fig. 1). The frequency of the vibration varied over time (5–50 Hz), low amplitude (0-0.2 mm) with a peak-to-peak acceleration of 1,38 g (g = gravitational acceleration). This type of vibrotherapy is referred to by the manufacturer as Oscillatory Cycloid Vibrotherapy (OCV). The subjects participated in a 3-week cycle of vibrotherapy or sham therapy, lasting ~ 60 minutes each, in a semi-recumbent position. Vibrotherapy treatments were performed in the number of 15, divided into 3 series of treatments, for 3 weeks (5 treatments during the next 5 treatment days), once a day and covered both knee joints. The devices for sham therapy did not have the function of generating measurable vibrations (acceleration a < 0.01 m / s2; frequency f < 0.01 Hz, amplitude A < 0.01 mm). From the outside, the devices did not differ visually from the vibration therapy devices and gave the same sound and light signals at the beginning and end of the therapy. The study was not blinded, and the researchers were aware of which stages of the study had been carried out on devices with vibrotherapy and which on sham devices.

Outcome Measures

The primary outcome measures used in this study were VAS [18] and Laitinen Questionnaire for pain and secondary outcome measures were TUG (Timed Up and Go Test) [19], active range of motion [20] and KOOS measurements [21].

Visual Analog Scale

The evaluation of knee joint pain was based on the Visual Analogue Scale (VAS) [18]. VAS is a widely accepted method of measuring the degree of pain and has been defined as a sensitive and reliable method compared to others [22]. VAS allows the patient to determine the pain level ranging from 0 to 10, with 0 being no pain at all and 10 the maximum (imaginable). Patients marked the level of pain immediately before and immediately after the procedures.

Laitinen Questionnaire

The Laitinen Pain Questionnaire is a subjective and point-based tool used to assess the level of pain symptoms [23]. Each indicator is assigned points from 0 to 4, where 0 is no problem and 4 is maximum problem. Bipolar 5-step gradation is used. The total assessment of pain according to the Laitinen Pain Questionnaire is the sum of points from four groups, i.e. pain intensity, pain frequency, frequency of taking painkillers and limitation of physical activity. The maximum number of points that can be obtained is 16 - which means an advanced level of pain, and 0 means no pain. Patients assessed the level of pain immediately before and immediately after the procedures.

Active Range Of Motion

The range of active movement in the knee joint was measured. The patient was lying on the couch in the forward lying position. The test was performed with the company's goniometer in accordance with the accepted standards [20]. All research tools used in the study were certified.

Tug Test

The functional state of the knee joints was tested in a fixed time schedule. The study included the subject assessment through the TUG test (Timed Up and Go Test). The test was carried out so that the patient was properly positioned on the test stand. The patient sat on a stable chair. After declaring readiness, the task was to get up, cover a distance of 3 meters and return to the chair. The test was carried out in triplicate and the mean was calculated. Normal value for a healthy adult is 10 seconds (s) or less [19].

Koos Questionnaire

KOOS (Knee Injury and Osteoarthritis Outcome Score) is used to assess the functional status of OA patients. The respondents indicated one answer that described the symptoms that had occurred during the last week. The questionnaire consists of 5 parts. In the first part, the patient determines the characteristics of the pain. In the second, he/she determines the severity of symptoms. In the third part, the patient defines the degree of difficulty in performing typical daily activities. The fourth part concerns sports and recreational activities, and the fifth part concerns the quality of life [9, 21].

Harm And Adverse Events

There were no occurrences of harm and adverse event reported during the period of trial.

Statistical analysis

The statistical analysis was done using Statistica version 13.0 software for Windows (Statsoft). All data are expressed as mean value (\(\underset{\_}{x}\)), standard deviation (SD), percentage distribution and 95% confidence intervals (95% CI). When analyzing the normal distribution, in order to compare the results obtained in the measurements before the treatments, the Student's t-test was performed for independent samples. When analyzing variables that were not normally distributed, the Mann-Whitney U test was used to compare two independent samples (results between groups). For individual measurement points of normally distributed variables, ANOVA was used with repeated measurements for dependent variables, with a qualitative factor grouping into the treatment group (Group 1) and control (Group 2). The Wilcoxon test was performed for pairs of observations in individual populations. Significant differences were determined at P < 0.05.

Characteristics of 32 patients are presented in Table 1. The mean age of patients was 64.28 ± 9.23.

The mean height was 1.62 ± 8.33. The frequency and percentage of female patients were higher than the male patients. The mean BMI of patients was 31.20 ± 5.48.

Table 1 Characteristics of study patients (n=32)

Characteristics^a	Group 1 (Vibration) n= 16	Group 2 (Control) n= 16	Total n=32	p-value*
Age (years)	63.69 ± 7.61	64.88 ± 10.84	64.28 ± 9.23	0.72
Height (meters)	1.62 ± 8.29	1.63 ± 8.60	1.62 ± 8.33	0.68
Weight (kg)	81.34 ± 17.71	83.02 ± 15.50	82.18 ± 16.39	0.78
BMI (kg/m2 )	31.04 ± 5.63	31.36 ± 5.51	31.20 ± 5.48	0.87
Gender:
Male	1 (20.00%)	4 (80.00%)	5 (15.6%)
Female	15 (55.56%)	12 (44.44%)	27 (84.4%)

^a Values represented as mean ( ) and standard deviation (SD) or frequency (percentage); *Values presented as level of significance with independent T test.
In the presented studies, it was observed that the use of OCV in patients with knee OA reduces the perception of pain. In Table 2, Group 1 (OCV therapy) shows more significant (< 0.001) improvement in pain level as compared to Group 2 (sham therapy) at the 1st and at the last session and at the 1st session and 4 weeks after the last session. The VAS scores improved more by 2.06 (<0.001) in the Group 1 than the Group 2, which improved by 0.63 (>0.05). For weeks after (follow up measurement) in Group 1 the level of pain remained the same level (Table 2).

In Table 3, Group 1 (OCV) shows more improvement in Laitinen scores at both the last session and the follow up as compared to Group 2 (ST). Mean Laitinen scores for the OCV group were 3.81±1.56 at the final session compared to the ST group, 4.19±1.28 (Table 3).

In Table 4, knee ROMs improved significantly (< 0.01) in Group 1 (OCV) as compared to Group 2 (ST) in the last session from baseline. There was more substantial improvement than baseline in flexion ranges after 15th session in OCV group (Table 4).

In Table 5, TUG improved significantly (< 0.01) in Group 1 (OCV) as compared to Group 2 (ST) in the last session from baseline and even more at follow up (<0.001). There was more substantial improvement than baseline after 15th session in OCV group (Table 5).

In Table 6, KOOS indicators improved significantly at pain scores (< 0.004) in Group 1 (OCV) as compared to Group 2 (ST) in the last session from baseline and at follow up (<0.03). There was more substantial improvement than baseline after 15th session in OCV group. Symptoms of the OA improved significantly only in group 1 (OCV) after the last session (<0.005) and at follow up (<0.006). Activities of daily living (ADL) improved more in in group 1 (OCV) after the last session (<0.005) and at follow up (<0.005). Also, sport and recreation function improved more in in group 1 (OCV) then in group 2 (ST). Quality of life improved significantly only in group 1 (OCV) after the last session (<0.003) and at follow up (<0.005). (Table 6).

Table 2 Between-group and within-group comparisons of VAS (N=32)

Groups n=32	Baseline	The last session (15^th session)	Follow up	Within-group comparison^b
Groups n=32	Baseline	The last session (15^th session)	Follow up	Baseline vs 15^th session	Baseline vs follow up
Group 1 (n=16)	5.44±1.46 (1.08-2.26)	3.38±1.36 (1.00-2.11)	3.38±1.31 (0.97-2.03)	2.06 (<0.001)	2.06 (<0.001)
Group 2 (n=16)	4.88±1.31 (0.97-2.03)	4.25±1.00 (0.74-1.55)	3.88±0.72 (0.53-1.11)	0.63 (>0.05)	(<0.02)
Between-group comparison^b (p-value)	0.56 (>0.05)	-0.87 (<0.05)	-0.50 (>0.05)

^aValues presented as mean ± standard deviation (95% CI); ^b Values presented as mean difference

Table 3 Between-group and within-group comparisons of Laitinen (N=32)

Groups n=32	Baseline	The last session (15^th session)	Follow up	Within-group comparison^b
Groups n=32	Baseline	The last session (15^th session)	Follow up	Baseline vs the last session	Baseline vs follow up
Group 1 (n=16)	6.06±2.05 (1.51-3.17)	3.81±1.56 (1.15-2.41)	3.88±2.31 (1.70-3.57)	2.25 (<0.002)	2.18 (<0.009)
Group 2 (n=16)	5.44±1.86 (1.37-2.88)	4.06±1.65 (1.22-2.56)	4.19±1.28 (0.94-1.98)	1.38 (<0.04)	1.25 (<0.04)
Between-group comparison^b (p-value)	2.18 (>0.05)	-4.47 (>0.05)	-0.11 (>0.05)

^aValues presented as mean ± standard deviation (95% CI); ^b Values presented as mean difference

Table 4 Between-group and within-group comparisons of ROM (N=32)

Groups n=32	Baseline	The last session (15^th session)	Follow up	Within-group comparison^b
				Baseline vs the last session	Baseline vs follow up
Group 1 (n=16)	102.94±24.48 (18.09-37.89)	108.88±19.05 (14.07-29.48)	107.00±16.47 (12.17-25.49)	5.94 (<0.01)	4.06 (>0.05)
Group 2 (n=16)	107.50±17.03 (12.58-26.36)	107.19±14.94 (11.04-23.12)	108.13±12.63 (9.33-19.55)	-0.31 (>0.05)	0.63 (>0.05)
Between-group comparison^b (p-value)	-4.56 (>0.05)	1.69 (>0.05)	-1.13 (>0.05)

^aValues presented as mean ± standard deviation (95% CI); ^b Values presented as mean difference

Table 5 Between-group and within-group comparisons of TUG (N=73)

Groups n=32	Baseline	The last session (15^th session)	Follow up	Within-group comparison^b
Groups n=32	Baseline	The last session (15^th session)	Follow up	Baseline vs the last session	Baseline vs follow up
Group 1 (n=16)	10.60±2.75 (2.03-4.25)	8.99±2.25 (1.66-3.49)	8.50±1.36 (1.01-2.11)	1.61 (<0.01)	2.10 (<0.001)
Group 2 (n=16)	11.45±2.58 (1.91-4.00)	10.92±3.53 (2.61-5.46)	10.15±3.71 (2.74-5.74)	0.53 (>0.05)	1.30 (<0.05)
Between-group comparison^b (p-value)	-0.85 (>0.05)	-1.93 (<0.02)	-1.65 (>0.05)

^aValues presented as mean ± standard deviation (95% CI); ^b Values presented as mean difference

Table 6 Between-group and within-group comparisons of KOOS (N=32)

Groups n=73

Baseline

The last session

(15^th session)

Follow up

Within-group comparison^b

Baseline vs the last session

Baseline vs follow up

Pain:

Group 1

(n=16)

55.54±18.84

(13.92-29.16)

67.04±14.57

(10.76-22.54)

66.42±17.84

(13.18-27.61)

11.5

(<0.004)

10.88 (<0.03)

Group 2

(n=16)

56.55±15.39

(11.37-3.82)

64.77±15.46

(11.42-23.93)

61.08±15.27 (11.28-23.63)

8.22

(>0.05)

4.53

(>0.05)

Between-group comparison^b

(p-value)

-1.01

(>0.05)

2,27

(>0.05)

5,34

(>0.05)

Symptoms:

Group 1

51.66±21.76

(16.07-33.68)

66.11±19.50

(14.41-30.18)

64.84±24.09 (17.80-37.29)

14.45

(<0.005)

13.18 (<0.006)

Group 2

52.34±21.87

(16.15-33.84)

60.13±16.81 (12.42-26.02)

56.76±15.63 (11.55-24.19)

7.79

(>0.05)

4.42

(>0.05)

Between-group comparison^b

(p-value)

-0.68

(>0.05)

5.98

(>0.05)

8.08

(>0.05)

ADL:

Group 1

50.12±20.96

(5.48-32.44)

68.26±16.70 (12.34-25.85)

68.80±16.71

(12.34-25.86)

18.14

(<0.005)

18.68 (<0.005)

Group 2

49.31±13.14 (9.71-20.34)

60.24±19.82 (14.64-30.67)

62.31±16.24

(11.99-25.13)

10.93

(<0.04)

13.00 (<0.03)

Between-group comparison^b

(p-value)

0,99

(>0.05)

8,02

(>0.05)

6.49

(>0.05)

Sport/Rec:

Group 1

35.47±24.70

(18.24-38.22)

49.84±25.52

(18.85-39.49)

49.19±30.36

(22.43-46.99)

14.37

(>0.05)

13.72 (<0.05)

Group 2

34.67±16.40

(12.12-25.38)

39.61±22.05

(16.29-34.13)

39.30±20.84

(15.39-32.25)

4.94

(>0.05)

-0.31

(>0.05)

Between-group comparison^b

(p-value)

0,80

(>0.05)

10,23

(>0.05)

9,89

(>0.05)

QOL:

Group 1

33.60±16.64

(12.30-25.76)

46.74±16.63

(12.29-25.74)

49.22±21.27

(15.71-32.92)

13.14

(<0.003)

15.62 (<0.005)

Group 2

40.49±10.92

(8.06-16.90)

46.09±15.12

(11.17-23.40)

45.70±13.45

(9.93-20.81)

5.60

(>0.05)

5.21

(>0.05)

Between-group comparison^b

(p-value)

-6.89

(>0.05)

0.65

(>0.05)

3.52

(>0.05)

^aValues presented as mean ± standard deviation (95% CI); ^b Values presented as mean difference

The current study is focusing on the effects of vibrotherapy (OCV) on the level of symptoms associated with knee osteoarthritis. The aim of the study was to compare the effects of OCV vibrotherapy with sham therapy to alleviate pain and functional disability in people with osteoarthritis of the knee joints. The conducted study showed a significant improvement in the group subjected to OCV, because the appropriate ranges of vibrations are able to stimulate the body to regenerate. Recently, therapeutic vibrations in the form of vibrotherapy have been included in the physiotherapy of osteoarthritis [24]. Vibrotherapy is also combined with other methods. including, inter alia, local or systemic administration of substances inhibiting inflammation (non-steroidal and steroidal anti-inflammatory drugs) [16]. Pain relief immediately after vibrotherapy is explained by the complex theory of pain [25, 26, 27, 28, 29]. In the present study, the VAS and Laitinen scores indicate an analgesic effect of vibrotherapy that may last for 4 weeks. A hypothesis was made that when a harmless stimulus, such as vibration, is applied directly to the skin at the site of pain, afferent nerve fibres of large diameter are activated by mechanoreceptors, causing a disproportionate increase in the number of large and small-diameter afferents [30]. This is confirmed by the research of Lurie et al. [31] and McGinnis et al. [32]. Guieu et al. noted that using while 30 minutes of vibrotherapy in patients with chronic pain, the analgesic effects were accompanied by a decrease in the level of substance P in the cerebrospinal fluid [33]. Similarly, Gill Taylor et al. [34] and Lobre et al. suggest that the decrease in the level of substance P is responsible for the analgesic effect after the vibrotherapy treatments. The ROM measurement was used to test the mobility of the knee joints. The range of motion in flexion increased significantly in the group with vibrotherapy. The effect, however, was not sustained when measured after 4 weeks. The influence of vibrotherapy on the muscles may trigger the activity of fibroblasts and stimulate the proper activity of collagen fibres, thus allowing the tissues to regain flexibility when stretched after traumatic injuries. Thanks to the cumulative analgesic effect, reduction of inflammation and tissue swelling, the perceived stiffness of tissues, including joints, can be reduced. This is confirmed by research conducted, among others, by Johnson et al. [38] and Peer et al. [39]. They prove that vibrotherapy brings significant and measurable benefits in terms of improving flexibility and reducing perceived stiffness in the joints in patients with various types of traumatic injuries to the musculoskeletal system. The presented research shows a significant improvement in the quality of life and functional state in patients with degeneration of the knee joints after using vibrotherapy. This is highlighted by the reduced TUG passing time. In the control group, a shortening of the TUG passing time was also observed. It is possible that it was caused by the daily physical activity of the patients who were required to attend the procedures. The ranges of active movement in the flexion of the knee increased during the therapy, however, this effect was not maintained satisfactorily over time after the end of the treatments (in post-treatment measurements). The improvement of quality indicators, which reflect the functional state, was found in both study groups. However, in the group undergoing vibrotherapy, the improvement was more pronounced and more lasting. The effect of increasing muscle strength after the treatments may be responsible for this. Pamukoff et al. [15] indicated that the action of vibration applied locally and in the area of the whole body, significantly improves the function of the quadriceps muscle of the thigh and may be effective in restoring its strength in people with degenerative changes in the knee joints. This is also evidenced by the studies conducted by Germann et al. [40] and Alam et al. who showed that vibrotherapy is the most effective when used in conditions of complete relaxation of the muscle tone. The tonic vibration reflex (TVR) activated this way stimulates involuntary muscle contractions forcing them to work without the participation and awareness of the patient [40, 41, 42, 43]. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index to assess short- and long-term symptoms and functions in patients with knee injury and osteoarthritis [44]. In the conducted studies, the group subjected to treatment had significantly better results in the subscales describing pain (Pain), symptoms (Symptoms), activities of daily living (ADL), activity in sport and recreation (Sport / Rec) and in the subscale of quality of life related to the knee (QoL). It is confirmed by a study by Paolucci et al. [45]. Patients with chronic pain (> 6 weeks) due to osteoarthritis of the knee joint (grade II-III in Kellgren-Lawrence score) were included sequentially and divided into two groups: with intra-articular oxygen-ozone therapy (O2O3) and with O2O3 and vibrotherapy. The Visual Analogue Scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), and the Medical Research Council (MRC) Manual Muscle Testing scale were assessed at baseline (pre-treatment), after 3 weeks of treatment, and 1 month after the end of treatment. Patients received intra-articular injections of O2O3 into the knee joint three times a week. The vibrotherapy group also underwent nine sessions (three sessions a week). The results of VAS, KOOS and MRC were significantly better in the group using O2O3 combined with vibrotherapy than in the group using O2O3 alone. The intragroup analysis showed that all scores improved over time compared to baseline and was maintained for up to 1 month after treatment. There were no adverse events. After the conducted research it was found that the improvement of medical technologies, allowing for non-invasive alleviation of pain, improving the work of the circulatory system and improving the functional state of patients with degeneration of the knee joints, can significantly contribute to accelerating the treatment process and reducing its costs compared to the so-called traditional treatments for the lesions in question. Adjusting vibrotherapy to the age, sex, general and local condition of patients, as well as verifying the effectiveness of the treatment used so far, can significantly alleviate the symptoms occurring in the course of OA. In many cases, the recommended physiotherapy cannot be performed with the required frequency. It mainly applies to patients with significant functional limitations and difficulties in reaching the place of its implementation. which, according to Alami et al., is often underestimated by doctors [41]. Therefore, the use of therapeutic methods (e.g. vibrotherapy) that do not interfere with other methods of treating degenerative changes in the joints, including the ones in the knees, and are possible at the patient's home, can be an effective complement to the overall treatment process.

Limitations

The findings of this study have to be seen in the light of the following major limitations. This study recruited the patients with non-probability purposive sampling technique due to the nature of patients’ characteristics requiring rehabilitation.

The study showed that vibrotherapy (OCV - Oscillatory Cycloid Vibrotherapy) is effective in relieving pain, improving range of motion and functional status in patients with OA. The therapy showed a significant improvement in terms of immediate and long-term influence on all analysed indicators. Therefore, it should be pointed out that it is an effective and safe method that can be added to conventional OA therapy to improve treatment outcomes, especially in patients with grade II OA. No adverse events occur.

OA: Osteoarthritis; VAS: Visual Analog Scale; KOOS: Knee Injury and Osteoarthritis Outcome Score; WBV: Whole-body vibration; OCV: Oscillatory Cycloidal Vibrotherapy; ST: Sham Therapy; TVR: Tonic Vibration Reflex

Acknowledgments

None

Authors’ contributions

APS: Substantial contribution to conception and design.

APS: Acquisition of data.

APS: Analysis and interpretation of data.

APS. JG. EG: Drafting of the manuscript.

APS. JG. EG: Critical revision of the manuscript for important intellectual content. All authors have read and approved the final manuscript.

Funding

Authors declare that this research study did not receive any research funding.

Availability of data and materials

The data is available from corresponding author on reasonable request

Declarations

Ethics approval and consent to participate

This study followed the Declaration of Helsinki. Ethical Approval was obtained from the Ethical Committee of Regional Medical Chamber in Cracow with Ref no. 120/KBL/OIL/2018. The study protocol was retrospectively registered on Australian New Zealand Clinical Trials Registry (ANZCTR) with ID: ACTRN12619000832178. Informed consent form was signed by patients before their participation in the study.

Consent for publication

Written informed consent was obtained from the patients for publication of identifying information/images in an online open-access publication.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors (dissertation research at Academy of Physical Education in Krakow, Poland)

Authors' contributions

APS and JG analyzed and interpreted the patient data and were a major contributor in writing the manuscript. EG performed the examination of the patients. All authors read and approved the final manuscript.

Acknowledgements

Not applicable

Author details

1 R&D Vitberg Jacek Sikora, Poland. 2 Academy of Physical Education in Krakow, Poland

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published 13 Apr, 2023

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Effect of low-magnitude, variable-frequency vibration therapy on pain threshold levels and mobility in adults with moderate knee osteoarthritis - randomized controlled trial

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Journal Publication

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Abstract

Figures

Background

Methods

Study Population

Study Duration

Data Collection Procedure

Masking

Intervention

Outcome Measures

Visual Analog Scale

Laitinen Questionnaire

Active Range Of Motion

Tug Test

Koos Questionnaire

Harm And Adverse Events

Statistical analysis

Results

Discussion

Limitations

Conclusion

Abbreviations

Declarations

References

Supplementary Files

Status:

Journal Publication

Version 1