Effects of Group-based versus Individual-based Spinal Stability Exercises (SSE) on Physical Health and Mental Wellbeing of Patients with Chronic Low Back Pain (LBP): A Randomized Controlled Trial (RCT)

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Abstract

Background: Several studies have demonstrated the efficacy of spinal stability exercises in physiotherapy management of back pain disorders. Physiotherapists traditionally can administer this exercise treatment either with the patient in group or one to one basis. There is dearth of information on the relative efficacy of group-based and individual-based spinal stabilisation exercise treatment approach. This raises the question of which method is more effective in symptom remediation and improvement in the health status of patients with chronic LBP?

Purpose: The purpose of this study was to compare the effect of group-based and individual-based SSE on bodily pain, functional limitation, physical health and mental wellbeing of patients with chronic LBP. Method: Thirty-five participants with chronic LBP were randomly assigned to undergo a SSE twice weekly week for 8 consecutive weeks in a group setting, and 35 participants received the same SSE on an individual basis during the same period. Functional limitation was assessed with Rolland Morris Disability Questionnaires. Bodily pain, physical health and mental well-being were evaluated with Rand 36 questionnaire. Assessments were carried out preintervention, post-intervention and at 3-month follow up.

Results: Significant improvement in bodily pain, functional limitation, physical health and mental well-being were found in both the group-based SSE and individual-based SSE post intervention (P=0.00). Functional limitation did not show significant difference between the two groups post intervention (P=0.497). Friedman ANOVA showed significant within-group differences over time in bodily pain, functional limitation. Physical health and mental well-being over time (P=0.00) that favoured the group-based SSE.

Conclusion: Findings from this study showed that group-based spinal stabilisation exercise interventions, is more effective in reducing pain, improving physical health and mental well-being of patients with chronic LBP than individually-based programs.

Keywords

Stabilisation exercise; Back pain; Physical health; Mental wellbeing; Functional limitation

Introduction

Lower back pain (LBP) is ranked first as a cause of disability and inability to work, and expected to affect up to 90% of the world’s population at some point in their lives [1]. Lower back pain is common in both older and younger adults but despite the high incidence and prevalence of LBP, studies have consistently shown high use of interventions poorly supported by evidence and lower use of interventions well supported by evidence [2,3]. Rehabilitation, recovery and care-seeking habits of LBP patients are often affected by many treatment and non-treatment factors [2,3].

A recent focus in the physiotherapy management of chronic LBP has been to identify specific muscles that are best able to stabilize the back and to carry out spinal stabilization exercises to enhance those muscles whose primary function is considered dynamic stabilization and segmental control of the spine [4,5]. Currently there is evidence demonstrating the efficacy of spinal stabilization exercises on pain, functional disability and quality of life in sufferers with acute and chronic low back disorders [6-8]. It is thought that stabilization exercises may reduce the effect of debilitating force generated within the spine during functional movement [7]. This can serve to decrease the risk of back pain by causing a reduction in tissue strain, deformation, compression, and overstretching [7]. The effects of stabilization exercise approach may be multifactorial involving physiological, psychological and other mechanisms yet to be well investigated [8,9].

Benefits of the exercises might as well be influenced by the mode of administering of the exercises. The possible modalities of administering spinal stabilisation (SSE) exercises are many and depends on the technique, duration, and whether the SSE are administered in group or individually. Physiotherapists traditionally can administer exercise treatment either with the patient in group or one to one basis. However, there appeared to be no evidence of superiority of group over individual exercise based interventions or vice versa.

Previous studies that utilised both group dynamics and individual treatment approaches did not focus on the use of exercise interventions in individuals suffering with LBP [10]. Conducted a randomized controlled trial to investigate the effectiveness of cognitive behavioral therapy, and compared the relative effectiveness of individual and group treatment approaches for anxiety disorders in children and adolescents. Their findings showed lack of significant differences between individual and group treatment approaches after the intervention and at one year follow-up [11]. Carried out a randomised controlled pilot study to compare the effects of group-based and individual-based motor skill training on motor performance in children with developmental coordination disorder. The outcome of their study showed that groupbased training produced similar gains in motor performance to individual-based training. There is dearth of information on the relative efficacy of group and individual based SSE and recommendations for either group or individual SSE based on its effectiveness for the treatment of LBP are lacking. Thus, the present study was designed to investigate the effects of group and individual based SSE in patients with chronic LBP.

Methods

The methodological flowchart is presented in Figure 1.

Objective

The purpose of the study was to compare the effect of group and individual based SSE exercises on bodily pain, functional limitation, physical health and mental well-being of patients with chronic LBP.

Ethics

Approval to carry out this study was obtained from the Research and Ethics Committee of the University of Maiduguri Teaching Hospital, Maiduguri. Detailed information on what the study was and what was expected of the participants was provided in participant’s information sheet. Participants were required to sign the written informed consent, and they were given enough time to decide whether they will take part in this study. They were also informed that their participation is voluntary and they are free to withdraw from the study at any point without any negative consequence on their subsequent treatment in the hospital.

Study design and source population

Single blinded RCT was designed with patients randomly assigned to 1 of 2 treatment groups: (1) a group-based spinal stabilisation exercises (GBSSE) and (2) Individual based spinal stabilisation exercises (IBSSE). Participants were enrolled from October 30, 2014, through December 20, 2014; follow-up data were collected through July 2015. Baseline for each patient was the date of randomization, which was also the date of their first visit and the date that the baseline questionnaires were completed. The source population consisted of the patients with LBP attending Physiotherapy Clinic at University of Maiduguri Teaching Hospital, Maiduguri, Borno-State, Nigeria.

Recruitment strategies

Participants were recruited from among patients with chronic low back pain from Physiotherapy outpatient’s clinics of the University of Maiduguri Teaching Hospital. Prior to this, printed recruitment posters and handbills were distributed to prospective participants in the outpatient clinic. Recruitment posters were also displayed on notice boards at strategic areas within these hospitals.

Eligibility criteria

Patients were eligible for the study if they were at least 18 years old, had a history of chronic and/or recurrent LBP (repeated episodes of pain in past year collectively lasting for more than 3 months), with or without leg pain, of a nonspecific nature (back pain complaints occurring without identifiable specific anatomical or neurophysiological causative factors) and had not received SSE treatment for their low back pain in the past. Patients had to be medically fit (no history of heart problems, pregnancy, inflammatory arthritis, etc.) LBP patients on pain medication were included if there had been no change in medicine and its dosage for one month or longer and have also agreed not to change their pain medication and/ or prescription till the end of the study. Patient with low back pain caused by red flag factors (such as cancer, tuberculosis, tumour and other serious spinal pathological conditions) as outlined in the Clinical Standards Advisory Group (CSAG) report for back pain (CSAG 1994) were excluded from this study. All subjects were interviewed and examined by a researcher who was unaware of their group allocation, to ensure that the inclusion and exclusion criteria were fulfilled.

Randomisation and blinding

Subjects were randomly assigned to 1 of the 2 intervention groups IBSSE and GBSSE via a computer-generated random number sequence. Randomisation was carried out by a researcher who was not involved in any other aspects of the study. Participants were not aware of the bases of allocation to each of the exercise groups because the study's objective was described to them in the following way: “to identify any differential effect between 2 different ways of administering exercises, which have a role in relieving their pain and protecting the spine from further injury”. The physiotherapist who performed the outcome assessments and data analyses was unaware of group allocation throughout the study. However, another physiotherapist who administered the exercise programs could not be masked to group allocation.

Sample size estimation

The trial was designed to have at least 80% power to detect a 2.5-point between-group difference in the scores of the RMDQ, the primary outcome measure in the study. This difference is considered as the minimally detectable important change [12]. Sample size estimation was performed with nQuery Advisor version 3.0 software for a common standard deviation of 3.7 points [13] and using a 2-group 1-tailed t test (P=.05), 38 subjects per group were required to detect a between-group difference for the RMDQ at the 90% level and 28 subjects per group at the 80% level.

Outcome measures and data collection

The primary outcome measure was Roland Morris Disability Questionnaire (RMDQ) while Rand 36 questionnaire was used as the secondary outcome measures. All assessments were carried out prior to participants’ first treatment (pre-treatment), at the end of 8-weeks of treatment (post-intervention) and at 3-months follow up.

Roland morris disability questionnaire (RMDQ): RMDQ was used to assess functional limitation. It is made up of 23 items that assess functional limitation due to LBP. In patient with chronic low back pain, participants were asked to mark the items that describe their low back pain on the day of the assessment an interclass correlation coefficient which range from 0.42-0.53 has been reported for the use of RMDQ [Smith and Grimmer-Somers 2010].

Rand 36 questionnaire: The Rand-36 questionnaire was used to assess bodily pain, and general health of participants with low back pain. It contains 36 items, which are identical to the MOS SF-36, with the scoring of items on Rand 36 questionnaire, a high score indicates an excellent (positive) outcome while a low score indicates a poor (negative) outcome. Rand 36 has been reported to be a reliable outcome measure to assess bodily pain, physical mental health variables and quality of life (r=0.96) [Ware and Sherborne 1992).

Interventions

Individual-based spinal stabilisation exercise (IBSSE)

A model of spinal stabilization exercise programme presented in this study began with audio visual information related to the spine and how the spine and local stability muscles work together to protect the spine was provided to aid mental imagery of correct performance prior to carrying out proper exercise protocol. Stabilization exercise protocols used in this study were similar to the one used in the previously reported studies [8,14]. It involves an initial 10mins warm up stretching exercises, 30 minutes of core spinal stability exercise and 10 minutes of cool down with stretching exercises. The participants in the individual exercise group underwent stabilization exercise treatment twice weekly for a period of eight weeks.

Group-based spinal stabilisation exercise (GBSSE)

Participants in this group underwent group-exercises protocol similar to the IBSSE above twice weekly for 8 weeks under the supervision of a physiotherapist. They were divided into four small groups, (each group comprising of not more than10 participants) according to their schedule preferences.

Data analysis

Statistical analyses were performed using Statistical Package for the Social Sciences, version 14.0. The Student t was used to assess differences in age and duration of LBP while chi-square tests was used to assess the differences in the number of male and female participants between the 2 groups. Friedman analyses of variance (ANOVAs) was used to assess changes over time in the dependent variables, taking into account pretreatment, post-intervention and 3 month follow up assessment period. Friedman ANOVA was used because the data did not show normal distribution pattern. In addition, Mann-Whitney U tests were used to assess between-group differences in the dependent variables measured at pre-treatment and post-intervention (i.e. pre-treatment and post intervention). The significance level for all statistical tests was set at P<.05. To determine the clinical relevance of the magnitude of changes, we estimated the effect size (ES) and interpreted it using the thresholds set by Cohen. Effect size is defined as the difference between 2 means divided by the pooled standard deviation; ES=(xÌ�−xÌ�/SDpooled); (SDpooled=

The cut-off points are: ES<0.20 (“trivial”), ES ≥ 0.20<0.50 (“small”), ES≥0.50<0.80 (“moderate”), and ES ≥ 0.80 (“large”).

Results

The flow of participants in the study is shown in Figure 1. Participants’ sociodemographic variables were presented in Table 1. Age, gender and duration of low back pain did not show statistical significant difference between the two groups (P>0.05).

Table 2 shows the result of the comparison of the pre-intervention and post-intervention scores of bodily pain, functional limitation, physical health and mental well-being between the two groups. Participants in the GBSSE had statistically significant higher scores (better outcome) with bodily pain (256.0 ± 84.7) than the participants in the individual based exercises (163.0 ± 49.5). Physical health and mental wellbeing also showed statistical significant difference between IBSSE and GBSSE (P<0.001). Functional limitation due to low back pain did not show statistical significant difference between the two group after intervention (P>0.05). The results of the effect size (ES) calculation on bodily pain, functional limitation, physical health and mental well-being carried out on all the dependent variables at all levels of data collection were less than 0.5 (Tables 2 and 3) Shows the Friedman ANOVA of within group changes over time in the bodily pain, functional limitation, physical health and mental wellbeing of participants in both groups. It shows that the participants in the group based SSE were able to maintain statistical significant improvements in bodily pain, functional limitation, physical health at 3-month follow up (P=0.00).

Discussion

The effectiveness of spinal stabilisation exercises has been well studied [4,6,9] but till now, no clear information on the relative benefits of doing the exercise either individually or in group has been reported. Thus, this study was to compare the effects of group-based and individual based Spinal stability exercises on bodily pain, functional limitation, physical health and mental wellbeing of individual with chronic low back pain. Seventy participants were recruited and completed 8 weeks of treatment. However, seven of the participants were lost to follow up (IBSSE=4 and GBSSE=3). Thus the drop-out rate in the both groups, IBSSE GBSSE were 11.1% and 8.5% respectively. The reason for the drop out given by 4 of the participants was relocation to a new area of abode which hindered their ability to attend the treatment and assessment sessions as scheduled while the 3 other participants did not give any reason. All the participants were present in the preintervention assessment and were also considered in the subsequent analysis based on the intention-to-treat analysis.

The findings of this study, in terms of what is already known include its reported benefits on pain and functional limitation in patients with low back pain [4,6,9]. The stabilisation exercise programme has become the most popular treatment method in spinal rehabilitation since it has shown its effectiveness in some aspects related to pain and disability. The outcome of this study showed a better outcome in the participants who underwent both individual-based and group-based spinal stabilisation exercises reported improvement in bodily pain and functional limitation. The spinal stabilisation exercise model is an active approach to management of LBP based on a programme of motor control exercises. The main mechanisms behind the pain relieving and functional restoration effects of this exercise programme on patients with LBP has been largely attributed to its ability to ameliorate the impairment or deficit in motor control around the neutral zone of the spinal motion segment, by restoring the normal function of the local stabiliser muscles [14,15] reported the that there is a likelihood of muscular contraction during spinal stabilization exercises providing sensory input to activate different pain inhibitory mechanisms in the central nervous system leading to an increase in the plasma serotonin level, as a possible mechanism of spinal stabilisation exercises induced analgesia. However, post intervention scores of functional limitation did not show significant difference among the two groups. This perhaps could be partly due to using a self-report questionnaire for the assessment of functional limitation in the present study. It could be that if the participants were engaged in interview to enquire about how the different methods of administration has impacted on their functions, their response might provide further information in this regard.

What is new, in terms of the findings of this study, perhaps might be the effects of administering spinal stabilisation exercise on physical health and mental well-being of chronic LBP patients using individual based and group-based exercise approaches. The outcome of this study has demonstrated better outcome in favour of group based spinal stabilisation exercises on physical health and mental well-being of the participants. There is increasing inquiry into the efficiency and effectiveness of stability exercises to ameliorate the menace of LBP, in addition to the effects of instability on the changes in kinematics of the spine [16]. It may be possible that spinal stabilisation exercise interventions delivered in a group format might represent an optimal intervention to improve physical health and mental well-being of LBP patients because the group format provides access to other LBP patients and thus could address psychosocial needs related LBP disorders. Considering the facts that QoL is comprised of both physical and psychosocial domains, it seems reasonable that group exercise interventions, by enhancing both physical health and mental wellbeing might be more effective in reducing pain, functional limitation and improving Quality of life of patients with chronic LBP than individually-based programs

Studies have shown that patients seek group interventions, specifically social support group interventions, for a number of reasons: they desire to dissipate their fear and reduce depression [17] they want to learn how to cope from other patients [17]. Group exercises were reported to give patients emotional support and promote social interaction [17].The mere presence of others sharing the same physical and psychosocial challenges can be quite profound. The group setting provides a normalization of experience [17] and can reduce feelings (i.e., anxiety, depression) patients often feel when surrounded by persons without same pathological disorders. Other valued aspects include the provision of hope and universality, or being in the same situation as other members [17]. It could also be possible that “mirror neurons” have been activated during group-based SSE. Mirror neurons have been associated with various forms of human behaviours: imitation, mind theory, new skill learning and intention reading [18]. Experiments have verified the existence of mirror neurons in the parietal-frontal circuit, when an animal was exposed to a task of observing a particular action or intention mad by another animal [19,20]. It was suggested that mirror neurons are part of a neural system where the observation of an action activates the cortical area of the observer’s brain [18-20]. Thus it could be that activation of motor neurons possibly associated with group exercise dynamics empowered participants in this group to better functional recovery than participants in the individual based SSE. If facilitated in a group exercise intervention, improvement in physical health and mental well-being obtainable through group processes possibly could occur alongside reported benefits obtainable from spinal stability exercise such as relieve of pain and functional limitation, improved motor control and reduce recurrence of LBP. Adherence with group exercise could be better than individual exercises because with the former, meetings are regular which could promote motivation among participants.

Implications for Practice

Findings from this study will have implications for physiotherapy management of LBP. Low back pain at the chronic stage could have negative effects on physical health, mental health, functional limitation and bodily pain, a better understanding of methods of administration of spinal stability exercises will provide a means of developing strategies to manage this condition more effectively. In terms of cost, it is possible that group-based spinal stabilisation exercise may be the preferred treatment option due to the associated cost savings because spinal stabilisation exercise treatment unlike electrotherapeutic modalities could be easily learnt by the patients and carried out as home treatment program by the patient without the physiotherapist. Also, in a groupbased exercise, it is possible for one therapist to attend to several patients at the same time quite unlike in the individual-based approach. The group-based approach might also constitute another means of reducing the delay in the time require to see physiotherapist in facilities where such delay exist.

Limitation of this Study

The data obtained from this study did not show normal pattern of distribution, thus parametric statistics could not be used for data analysis and post-hoc analysis of the effects of intervention on the dependent variables was not carried out. Lack of normal pattern of distribution could perhaps be due to using self-report outcome measures in this study. There are many barriers present in accurately diagnosing and assessing severity of function, physical health mental well-being with self-report questionnaires [21,22]. It could be that if standard measures for diagnostic assessment (e.g. the Structured Clinical Interview) were used these results might be different. The internal and external validity of this study could have been further enhanced by using participants who will receive no intervention as the control group. However none of the prospective participants agreed to stay off treatment by being allocated to no intervention control group. This could have been possible if patients in the no intervention control group will agree to treatment intervention after the completion of the study provided it will not have deleterious effects on their low back disorder.

Conclusion

Findings from this study showed that group-based spinal stabilisation exercise interventions, is more effective in reducing pain, improving physical health and mental well-being of patients with chronic LBP than individually-based programs.

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Tables and Figures at a glance

Table 1	Table 2	Table 3

Figures at a glance

Figure 1