Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study☆
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Published Online: July 28, 2014
Abstract
Objective
To evaluate the efficacy of a novel, angular, continuous passive motion device for self-treatment at home in patients with mild-to-moderate, non-specific, chronic low back pain (LBP).
Design
Prospective, randomised, waiting-list-controlled (WLC) trial.
Setting
Recruitment and assessment were conducted at the Koren Centre for Physical Therapy. Self-treatment was performed at home.
Participants
Thirty-six patients with a score ≤6 on the numeric rating scale (NRS) for pain were enrolled. Twenty-eight patients completed treatment.
Interventions
Participants were randomised to receive the Kyrobak (Radiancy, Hod-hasharon, Israel) at enrolment [immediate treatment (IT) group] or 3 weeks later (WLC group). Self-treatment was prescribed for 10 minutes, one to three times per day, for 3 weeks. The treatment period was followed by a 3-week follow-up period.
Main outcome measures
Primary outcome was self-reported pain level (NRS).
Results
Three weeks of self-treatment with the Kyrobak reduced pain levels significantly in the IT group compared with the WLC group {mean [standard deviation (SD)] ΔNRS score from baseline to post-treatment: IT group, 1.4 (1.5), 95% confidence interval (CI) 0.5 to 2.3; WLC group, −0.1 (2.2), 95% CI −1.1 to 1.2; effect mean difference 1.5}. This benefit was maintained over the follow-up period [from baseline to end of follow-up, mean (SD) ΔNRS score 1.1 (1.8), 95% CI 0.4 to 1.8]. Multi-linear regression analysis found that higher baseline pain resulted in greater pain reduction (P = 0.003). Eighty-three percent of participants with a baseline NRS score >4.35 (threshold determined by logistic regression, P = 0.01) achieved the minimal important change criterion of ΔNRS score ≥2. Daily NRS score reduced gradually over the treatment period [regression slope −0.052 (0.01), 95% CI −0.07 to −0.03].
Conclusions
Preliminary evidence suggests that the Kyrobak may be beneficial for short-term relief of non-specific, chronic LBP, particularly in participants with a moderate level of pain. A longer treatment period may lead to a further reduction in pain.
Introduction
Non-specific low back pain (LBP), not attributable to a specific pathology, is a widespread problem that affects all age groups, with the most prominent impact on quality of life in adults [1]. Chronic LBP lasting for more than 3 months [2] is increasing as the population ages [3].
Treatment options for non-specific LBP include treatment by a physiotherapist, medications, acupuncture and exercise. However, the level of effectiveness of these treatments varies between individuals [[4], [5], [6], [7], [8]]. Therefore, there is a need for additional interventions with proven efficacy.
An alternative approach to treatment of LBP is the use of devices based on continuous passive motion (CPM). These motorised devices provide passive movement in a specific plane, thereby enabling the joint to pass through a predetermined range of motion [9]. The most common indication for CPM in the clinical setting is the avoidance of arthrofibrosis following trauma or joint surgery, particularly after total knee arthroplasty [10], although recent studies questioned the effectiveness of CPM in postacute rehabilitation [[11], [12], [13], [14]]. Over the past decade, CPM management of LBP has been investigated in experimental models [[15], [16], [17], [18]] and a case study in humans has been published [19]. A small number of CPM devices have been developed for self-treatment of LBP. These devices have been engineered to mobilise the lower spine in various planes, including anterior/posterior pelvic tilt in the supine position at home [20] or lumbar spinal (rotational) movement during sitting at work [[21], [22]]. A CPM device that creates alternate side flexion of the back has not been described to date. To the authors’ knowledge, a pragmatic study of self-treatment at home using a CPM device for management of LBP in humans has not been published, to date, in the medical literature.
This study describes a novel CPM self-treatment device for use at home that moves the lower vertebra by angular oscillation in the supine position, thereby creating alternate side flexion of the back. This clinical study was designed to determine the efficacy of the device for short-term pain reduction in participants with mild-to-moderate, non-specific, chronic LBP.
Methods
Design overview
This study was a prospective, randomised controlled trial (RCT). Participants with mild-to-moderate, non-specific, chronic LBP were randomised to receive the device either at enrolment [immediate treatment (IT) group] or 3 weeks later [waiting-list-control (WLC) group]. The 3-week treatment period was followed by a 3-week follow-up period.
Participant-reported outcomes including pain levels [numeric rating scale (NRS) for pain and Oswestry disability index (ODI) for functional health status] were documented at each clinic visit. In addition, throughout the study, participants were required to document daily NRS pain scores and complete weekly ODI questionnaires in a diary.
The primary outcome was the pre- to post-treatment change in NRS score after 3 weeks of daily treatment. Secondary outcomes were the pre- to post-treatment change in ODI score after 3 weeks of daily treatment, and changes in NRS and ODI scores from baseline to the end of the 3-week follow-up period.
Setting and participants
Participants were recruited from the Jerusalem district through advertising in local media, and were initially screened over the telephone. Potentially eligible participants were invited for an interview at the Koren Centre for Physical Therapy (Mevasseret-Zion, Israel; 10-minute drive from Jerusalem). Screening procedures over the telephone and at the clinic were conducted by certified physiotherapists. The inclusion criteria were: age ≥18 years; and mild-to-moderate (NRS score ≤6), chronic (present for more than 3 months) LBP of non-specific aetiology. The exclusion criteria were: LBP of specific and known aetiology; recent history of violent trauma; and history of back surgery. A detailed list of the inclusion/exclusion criteria can be found in the online supplementary material.
An orthopaedic spinal surgeon was consulted if questions were raised regarding the aetiology of the LBP during enrolment, and during the study in cases of pain aggravation, evaluation of a potential adverse event, or if a patient felt the need to consult with the surgeon during the treatment/post-treatment period.
Randomisation
Randomisation was performed by a third party who was not involved in either the screening process or any evaluations during the study. A detailed description of the randomisation procedure can be found in the online supplementary material.
Interventions
The Kyrobak (Radiancy, Hod-hasharon, Israel) is an electrically operated CPM device that creates slow angular oscillations of 6° (total amplitude 12°). It consists of a lightweight plastic body and a treatment surface that is padded with expanded rubber (ethylene vinyl acetate), and contains a control unit to select the oscillation frequency (low, medium or high = 24, 28 or 30 cycles/minute, respectively) and turn the device on or off (Fig. 1). The participant places their pelvis on the centre of the platform in the supine position, and either flexes the knees to 30° to 45° while placing their feet on the floor, or flexes the knees to 90° while placing their legs and feet on a chair. The Kyrobak turns off automatically after 10 minutes of continuous treatment.
Fig. 1
Kyrobak angular continuous passive motion device.
At the clinic, on receipt of the Kyrobak, a physiotherapist instructed the participants about proper use of the device, correct body position, and the possibility that temporary discomfort or pain could be experienced during initial treatment because new movements that the body is not used to may elicit temporary pain aggravation. This was also disclosed in the informed consent form. A user manual was also provided. At home, the participants were expected to perform up to three, 10-minute, self-treatment sessions per day. The criterion for treatment compliance was at least one treatment per day for ≥18 days during the 21-day treatment period. At the end of the treatment period, participants returned the Kyrobak devices to the clinic.
Outcomes and follow-up
Primary outcome
The primary outcome was self-reported pain level. This was evaluated using the NRS (range 0 to 10, 0 = no pain and 10 = worst pain imaginable).
Secondary outcome
The secondary outcome was disease-specific functional health status. This was evaluated using the Hebrew version of the validated ODI [23] (range 0 to 100, 0 = no disability and 100 = most severely disabled). Regarding safety, participants were asked to notify the clinical team of any adverse events.
Baseline data were collected at the randomisation visit (see detailed list in the online supplementary material). Each clinic visit included self-evaluation of NRS and ODI scores. Participants could not see their previous NRS/ODI scores. The participants were given a home diary to record daily NRS scores and weekly ODI scores, and add comments on any related/non-related events (travelling, special activity, etc.) and use of acute pain medication. During the treatment phase, the participants were also asked to record the time of treatment and the number of daily treatments. These data were used to determine treatment compliance. At the termination visit, the participants were asked to complete a questionnaire pertaining to device usage and comfort.
Participants were instructed to continue their normal everyday activities. However, participants who received active conservative care (i.e. physical therapy, chiropractic treatment) for LBP during the study or who used acute pain medication [e.g. non-steroidal anti-inflammatory drugs (NSAIDs)] on more than two occasions during the treatment phase were excluded from the analysis to avoid bias.
Power calculations
Power calculations were based on the criterion for minimal important change (MIC = 0.3 [24]) of improvement-over-baseline assuming that without treatment mean = 0.087 [20] and SD = 0.26 [20]. To reach a significance level = 0.05 and power> 0.8, a sample size of 12 participants in each group (i.e. 24 in total) would be sufficient.
Statistical analysis
The database was validated by two independent observers by double entry, and any differences were corrected according to the original clinical report form. The analysis was performed on all participants using intention-to-treat principles. There were two stages of data analysis: (1) comparison of the WLC group with the IT group; and (2) analysis of pooled treatment completers from both the WLC and IT groups.
NRS/ODI scores are reported as mean (SD) or percentage. Baseline data including gender, age, body mass index, risk factors and symptom duration are reported as mean (SD) or frequency. Shapiro–Wilk's model was used to test for normal distribution of the parameters. The analysis was repeated using non-parametric statistics for parameters with a non-normal distribution (body mass index, end of follow-up NRS score for IT group, ODI score).
Chi-squared tests or two-tailed, unpaired t-tests were used, where appropriate, to compare the baseline data between groups. Unpaired/paired t-tests (or non-parametric Mann–Whitney U-tests or Wilcoxon signed ranks tests) were used to compare changes in NRS or ODI scores (improvement over baseline) between groups, and between visits, with Bonferroni's correction where appropriate. A change in ODI score >10 points was considered to indicate clinical significance.
A multi-linear regression model was used to investigate dependence on covariates (age, gender and baseline pain). Logistic regression was used to determine the cut-off baseline NRS score that could predict the MIC (NRS score improvement over baseline ≥2 [24]). The trend in maximal daily NRS score (recorded in the diaries) was characterised for individual patients by determining the regression slope of NRS score by day. Baseline pain for this analysis was defined as the average NRS score of the first 4 days. Statistical analysis was performed using Systat-13 with the exact test module (Systat Software, Chicago, IL, USA). Re-analysis was corroborated by an unaffiliated statistical service company (Medistat Inc. Tel-Aviv, Israel) using SAS Version 9.2 (SAS Institute, Cary, NC, USA).
Results
Participant accountability
Fig. A1 (see online supplementary material) shows a CONSORT diagram of participants through the trial. Of the 36 randomised participants, 35 received a Kyrobak, 28 completed the treatment period and 25 completed the follow-up period. One participant used NSAIDs more than twice during the treatment phase and was therefore excluded from the analysis. During the treatment phase, seven participants dropped out for the following reasons: three had temporary pain aggravation (acute and self-limited) after use, two perceived the treatment to be inefficient and decided to stop using the Kyrobak after a limited number of treatments, and two had device-related technical issues. Three participants did not return to the clinic on time for the follow-up visit and were therefore considered to be lost to follow-up.
Demographic data and baseline characteristics
Table 1 shows demographic data, risk factors and baseline characteristics collected at the randomisation visit. No significant differences were found between the IT and WLC groups. LBP symptoms had been present for more than 2 years in 85% of the participants. All but one participant (35 of 36) had tried at least one other, non-pharmacological treatment to relieve their LBP, and all had used some form of medication prior to entry into the trial.
| Data | Variable or characteristic | IT group (n = 18) | WLC group (n = 18) | P-valuea | All (n = 36) |
|---|---|---|---|---|---|
| Demographic | Male sex, n (%) | 12 (67%) | 8 (44%) | 0.18c | 20 (56%) |
| Age (years) | 53.2 (10.0)b | 47.1 (16.8) | 0.19d | 50.1(13.9) | |
| Body mass index (kg/m2) | 26.4 (4.0) | 25.6 (5.4) | 0.21e | 26.0 (4.7) | |
| Risk factors | Occupation | ||||
| Non-physical, stationary | 11 | 14 | 25 | ||
| Non-physical, non-stationary | 4 | 3 | 0.59f | 7 | |
| Physical | 3 | 1 | 4 | ||
| Smoking status | |||||
| Current smoker | 2 | 1 | 3 | ||
| Ex-smoker | 7 | 4 | 0.52f | 11 | |
| Non-smoker | 11 | 14 | 25 | ||
IT, immediate treatment; WLC, waiting list control.
aP-value for comparison between IT and WLC groups.
bMean (standard deviation).
cChi-squared test.
dTwo-tailed t-test.
eMann–Whitney U-test (non-normal distribution).
fFisher's exact test.
Stage 1: comparison of WLC group and IT group
The IT group reported a significant reduction in pain at the end of the first 3 weeks of the study protocol (38% improvement compared with baseline), but this was not the case for the WLC group [mean (SD) ΔNRS score from pre- to post-treatment: IT group, 1.4 (1.5), 95% CI 0.5 to 2.3; WLC group, −0.1 (2.2), 95% CI −1.1 to 1.2; effect mean difference 1.5]. Thus, the WLC group showed no benefit from the anticipation of treatment. After the WLC period, participants in the WLC group completed the 3-week treatment protocol, and were also found to experience significant pain reduction (see Table 2). This reduction was not significantly different between the groups (WLC vs. IT). As such, data for all treatment completers were pooled for further analysis.
| Group | NRS score WLC | NRS score, pre-treatment, mean (SD) | NRS score, post-treatment, mean (SD) | NRS score, end of follow-up, mean (SD) | ΔNRS score WLC/pre-treatment, mean (SD) [95% CI] | ΔNRS score from pre- to post-treatment, mean (SD) [95% CI] | P-valuea |
|---|---|---|---|---|---|---|---|
| IT | 3.9 (1.5) (n = 18) | 2.4 (1.5) (n = 14) | 2.6 (1.9) (n = 13) | 1.4 (1.5) [0.5 to 2.3] | 0.005 | ||
| WLC | 3.8 (1.7) (n = 18) | 4.0 (1.6) (n = 17) | 3.1 (1.5) (n = 13) | 3.4 (1.7) (n = 13) | to 0.1 (2.2)b [−1.1 to 1.2] | 1.2 (1.3) [0.4 to 1.9] | 0.006 |
| Pooled treatment completers | 4 (1.5) | 2.7 (1.5) | 3.0 (1.8) | 1.3 (1.4) [0.7 to 1.8] | <0.001 |
NRS, numeric rating scale; IT, immediate treatment; WLC, waiting list control; SD, standard deviation; CI, confidence interval.
aComparison of pre- and post-treatment using paired two-tailed t-test.
bWLC (randomisation/pre-treatment) vs. IT (pre-/post-treatment); P = 0.037.
Stage 2: effectiveness of the intervention for pooled treatment completers
A significant reduction in the level of LBP was achieved after 3 weeks of daily treatment [mean (SD) pre- vs. post-treatment NRS score (n = 27): 4 (1.5) vs. 2.7 (1.5); P < 0.001 by paired two-tailed test; mean (SD) ΔNRS score: 1.3 (1.4), 95% CI 0.7 to 1.8]. The reduction in pain levels was maintained 3 weeks later without further treatment [mean (SD) ΔNRS score from baseline to end of follow-up: 1.1 (1.8), 95% CI 0.3 to 1.8; P = 0.014, Wilcoxon signed ranks test with Bonferroni's correction for multiple comparisons].
Multi-linear regression analysis showed that the main contributor to the outcome was baseline pain level (P = 0.003; i.e. greater reduction for higher initial pain levels). In addition, males were found to respond better than females regardless of baseline pain level [mean (SD) pre- vs. post-treatment NRS score: males 1.71 (0.3) vs. females 0.73 (0.34); P = 0.04, analysis of variance adjusted for baseline pain]. Age did not contribute to the outcome (P > 0.5).
Logistic regression showed that a threshold level of baseline pain of 4.35 had predictive power for MIC ≥ 2 [24] (P = 0.01). The area under the receiver operating characteristic curve was 0.82. Indeed, 10 of 12 (83%) participants with baseline pain >4.35 achieved the MIC, whereas only two of 15 (13%) participants with baseline pain below the threshold achieved the MIC (P < 0.001, Chi-squared test).
Daily pain levels during the treatment phase, as recorded by the subjects in the home diaries, were characterised by a gradual decreasing trend over time [mean (SD) NRS score/day: −0.052 (0.01), 95% CI −0.07 to −0.03] that did not show a tendency to plateau (Fig. 2). The multi-linear regression model indicated that pain reduction was significantly dependent on baseline NRS score. According to the results of the model, the estimated ΔNRS score for 21 days was −0.67, −1.34 and −2.02 for baseline pain of 3, 4 and 5, respectively [model for daily pain: ΔNRS score = 0.064 − 0.032 × baseline NRS score]. Age and gender were not found to contribute significantly.
Fig. 2
Daily pain levels by experimental period. Data points are worst daily pain level by mean (standard deviation) numeric rating scale (NRS) scores for all participants by day. The left-hand figure shows the period of daily treatment, and the right-hand figure shows the follow-up period after the Kyrobak was returned. Note the gradual reduction in NRS scores over time during the treatment phase that appears partially sustained during the post-treatment phase.
Only five of 27 (19%) participants achieved a clinically significant reduction in ODI score (≥10 points) after 3 weeks of daily treatment; four of these patients had moderate disability (ODI score 20 to 40) at baseline.
Regarding safety of the Kyrobak, the movement produced is relatively small and slow. This type of motion is not known to cause major back pathologies, although temporary discomfort/pain during the initial treatment was anticipated. Five participants reported device-related, acute, self-limited pain that resolved within several days without further intervention. The participants were re-examined by the clinicians to rule out any long-term effects. No serious device-related adverse events occurred during the study.
All of the participants (30/30, 100%) who completed the questionnaire reported that the Kyrobak was easy to use, and most participants (25/30, 83%) reported that use of the device was easy to incorporate into their daily routine.
Discussion
This study found a significant baseline-dependent reduction in non-specific, chronic LBP after 3 weeks of self-treatment with an angular oscillating CPM device. The reduction was gradual over the treatment period and was maintained during the 3-week follow-up period. This sustained gradual improvement suggests that longer periods of treatment may result in further improvement. The pre- to post-treatment decrease in pain was found to be affected by gender, with males experiencing better improvement than females (P = 0.04). No such gender effect could be demonstrated for daily pain reduction. Therefore, this effect cannot be considered to be generalisable. Improvement in functional health status, as evaluated by ODI score, was not observed in this study. However, ODI score is not expected to change in time periods less than 3 months. The treatment was safe and did not result in any serious device-related adverse events. Cases of pain aggravation were acute and self-limited (pain resolved without further intervention).
The original idea of CPM, suggested by Salter [25], was based on the observation that immobilisation is unhealthy for joints, whereas joint motion promotes the healing and regeneration of articular cartilage [1]. The application of CPM devices in LBP is based on observations from several animal models showing that the immobilisation of avascular intervertebral discs leads to structural weakness, degeneration [[15], [16]] and atrophy of muscles adjacent to the motion segment [17]. CPM-induced spinal motion has been shown to enhance solute transport and nutrient waste exchange in intervertebral discs in a canine model [18]. In humans, Maitland et al. showed that small passive repetitious joint movements can increase mobility of the facet joints and decrease LBP [26]. From a biomechanical standpoint, CPM devices may create oscillatory deformation of intervertebral discs (compression, torsion and rotation). Such oscillatory compression may induce augmentation of internal pressure gradients leading to fluid flow through disc pores to the surrounding tissue. Other deformations, including torsion and rotation, are associated with minimal fluid flow because the change in disc volume is small or negligible, respectively [27]. Angular deformation, such as that created by the Kyrobak, may induce enhanced oscillatory fluid flow through discs in a lateral direction due to the periodic compression that (porous) discs generate by the alternate side flexion of the back. Enhanced fluid flow may increase solute transport and nutrient waste exchange in intervertebral discs. Future preclinical studies are needed to verify if movement induced by the Kyrobak creates such fluid flow in the intervertebral discs, and to associate this mechanism with pain reduction.
To the authors’ knowledge, three devices used in the supine position are available commercially. Two are home-use devices that provide CPM for mobilisation of the lower spine in the sagittal plane – extension followed by anterior pelvic tilt which creates decompression: Back-to-Life (Backlife Ltd, Rishpon, Israel) and Swing Swimming (Daito Electric Industry, Higashiosaka, Japan). The third device, SpineSix BioMotion Spinal Systems (MediCepts, Stuart, FL, USA), is a clinic-based CPM device that moves the lumbar spine in various planes. Published results on the effects of these CPM devices on LBP are limited. In an RCT using the Back-to-Life device, significant pain reduction was found after six clinic-based treatment sessions compared with a sham-device placebo (23% vs. 8.7%) [20]. In a case report study (n = 3), the SpineSix BioMotion system was demonstrated to clinically improve the ODI score [19]. The current study found a clinically significant decrease in pain (MIC > 2) in 83% of the participants with moderate baseline LBP (>4.35). The greater benefit of the Kyrobak compared with the other CPM devices may be dependent on the specific plane of motion, but also on the number of sessions as suggested by daily NRS scores showing that additional sessions may lead to greater pain reduction.
Studies of other types of non-pharmacological therapies for management of non-specific, chronic LBP including exercise [28], acupuncture [29] and massage [30] have shown that each of these strategies is more effective for reducing pain compared with no treatment [[8], [28], [29]]. It is important to point out that apart from exercise at home, the non-pharmacological therapies noted above require assistance by a caregiver, whereas CPM self-treatments do not. This decreases the costs of such treatments. Future clinical multi-arm studies comparing CPM with other types of non-pharmacological therapies would be of interest.
The RCT WLC design is used extensively in pain studies [31], and specifically in non-pharmacological, chronic LBP studies [[32], [33], [34]]. Devising a placebo, home-based self-treatment sham device, where the participant is in contact with the device on a daily basis, is problematic as some of the participants would have recognised the lack of movement, leading to significant loss of compliance [[35], [36]]. Limited information on the effects of alternative CPM devices precluded their use as plausible alternative controls. Finally, the main limitations of this study included the small sample size, variability of use at home, and lack of longer treatment and follow-up periods. Nonetheless, the statistical and clinical significance of the NRS scores in spite of the sample size indicates a clear benefit.
Conclusions
Three weeks of daily self-treatment with the Kyrobak was found to have a short-term beneficial effect on LBP, particularly in participants with moderate levels of pain. The Kyrobak is safe and easy to use. Although the current study provides valuable information concerning the effects of this device, longer term treatment and follow-up are needed to assess the long-term effects of this intervention.
Ethical approval: This study was approved by Helsinki Committee of Herzog Hospital (#202-12) and the Israel Ministry of Health (#HT-6211). All participants provided informed consent.
Funding: Funding was provided by Radiancy, Israel to cover coordinator time, administrative costs and consultant compensation. The funding source had no involvement in the collection, reporting or analysis of the data.Conflicts of interest: The authors received compensation for their time as consultants.
Appendix A. Supplementary data
The following are the supplementary data to this article:
Supplementary Fig. A1
CONSORT flow diagram for participant recruitment and randomisation.
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