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Rehabilitation medicine
Protocol
Effectiveness of a physiotherapy self-management programme for adult patients with chronic non-specific low back pain in low- and middle-income countries: protocol for a systematic review and meta-analysis
  1. Sergant Given Motha1,
  2. Niri Naidoo2,
  3. Maureen Moyo-Chilufya3,
  4. Alfred Musekiwa3,
  5. Kabelo Kgarosi3,
  6. Karien Mostert1
  1. 1Department of Physiotherapy, Faculty of Health Sciences, University of Pretoria, Pretoria, Gauteng, South Africa
  2. 2Division of Physiotherapy, Department of Health and Rehabilitation Sciences, University of Cape Town, Rondebosch, Western Cape, South Africa
  3. 3School of Heath Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, Gauteng, South Africa
  1. Correspondence to Mr Sergant Given Motha; u98201612{at}tuks.co.za

Abstract

Introduction Chronic non-specific low back pain (CNLBP) is among the most common musculoskeletal system conditions reported worldwide; however, few studies are available from low- and middle-income countries (LMICs). Self-management is a set of tasks performed by the patient aiming at managing their symptoms and interference in activities, mood and relationships due to pain. A physiotherapy-guided self-management programme (SMP) following a biopsychosocial approach has been reported as effective and affordable in the management of CNLBP in high-income countries. The objective of this systematic review is to determine the overall effectiveness of SMPs for adults with CNLBP in LMICs.

Methods and analysis In this systematic review, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocol (PRISMA-P) guidelines will be followed. A three-step search strategy will be used to search the electronic databases (PubMed, MEDLINE, SPORTDiscus, Scopus and CINAHL, Academic Search Complete and PEDro) for randomised controlled trials assessing the effectiveness of physiotherapy-guided self-management for CNLBP among adult participants in LMICs. The processes of screening search results for eligible studies, extracting data from included studies and appraising will be done independently by at least two review authors. Random effects meta-analysis will be used to synthesise results and heterogeneity will be assessed using the I2 test statistic and χ2 test.

Ethics and dissemination Ethics clearance was obtained for the broader PhD study on the development of a physiotherapy-guided SMP for adult people with CNLBP in Limpopo Province, South Africa. The results of the manuscript for this protocol will be published in peer-reviewed journals and also presented at conferences, symposia, and congresses.

PROSPERO registration number CRD42023399572.

  • sports medicine
  • public health
  • primary health care
  • pain management
  • musculoskeletal disorders
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-073916

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    STRENGTH AND LIMITATIONS OF THIS STUDY

    • This is a protocol to conduct a systematic review of the effectiveness of physiotherapy-guided self-management interventions in low- and middle-income countries (LMICs). This summary of evidence can be used to develop a physiotherapy-guided self-management programme within the LMICs.

    • The language restriction will not be applied to the selection of studies. This will reduce the risk of bias and enhance the study findings.

    • Compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocol checklist and the Cochrane handbook guide will be used for methodological rigour.

    • The operationalisation of the search strategy will be developed by an experienced librarian and tailored to six large databases.

    • The possibility of limited studies and the low quality of some studies may affect the outcome or evidence of this systematic review.

    Introduction

    Chronic non-specific low back pain (CNLBP) is one category of low back pain (LBP). According to the WHO, CNLBP or LBP is the most common musculoskeletal condition globally with a high prevalence and leading cause of disability, especially in low- and middle-income countries (LMICs).1 It was also projected that the number of people with LBP will increase in the future and even quicker in LMICs.1 2 CNLBP is a musculoskeletal condition that is not attributable to a recognisable or known specific pathology (eg, infection, tumour, fracture, structural deformity, inflammation disorder, radicular syndrome or equine syndrome) and persists for more than 12 weeks.3 According to the classification of low back pain (LBP) attached in figure 1, recurrent low back pain (RLBP) and persistent low back pain (PLBP) form part of CNLBP. In the current systematic review, the CNLBP is defined as LBP that persisted for at least more than 3 months excluding known specific pathologies and including RLBP and PLBP. According to World Bank Atlas methods, low-income countries are defined as those countries with a gross national income (GNI) per capita, calculated using the World Bank Atlas method, of $1,135. On the contrary, middle-income countries are those with a GNI per capita, of more than $4,446 but less than $13,845.4

    Figure 1
    Figure 1

    Classification of low back pain (LBP).

    Rehabilitation, in its essence, is a set of interventions needed when a person is experiencing limitations in everyday physical, mental and social functioning due to ageing or a health condition, including chronic diseases or disorders, injuries or trauma.1 2 The WHO has proposed non-drug, non-surgical approaches as the first line of treatment for LBP, including education on pain management, manual therapies and exercise rehabilitation. This type of rehabilitation is an important element in addressing the global burden of musculoskeletal conditions, including LBP.2 A recent clinical guideline recommended the biopsychosocial approach or self-management as the best management for CNLBP.5 The biopsychosocial approach consists of three components, namely, biological (associated with the relationship of disease and body health), psychological (aspects of mental and emotional wellness that also relate to behaviour) and social (interpersonal factors such as social interactions and community activities).6 7 This approach was also used by the WHO to publish its International Classification of Functioning, Disability and Health (WHO ICF).8 In addition, a biopsychosocial approach has been broadly used in research on rehabilitation and disability, which includes chronic pain and functional disorder.9 10

    However, the implementation of physiotherapy-guided self-management is challenging, particularly in LMICs.5 The physiotherapy-guided self-management programme (SMP) should include both biomedical and psychosocial elements, where the biomedical elements tend to be the current standard of care approach, that is, electrotherapy, myofascial release and mobilisation.11 12 Literature on the biopsychosocial approach as management of chronic musculoskeletal conditions exists; however, research on this approach in CNLBP in LMICs is lacking.5 13–16 The current literature, including reviews done in LMICs for the management of CLBP or LBP and the implementation of the available treatment guidelines, is limited.5 14 A preliminary literature search was done in the Cochrane Database of Systematic Reviews and the JBI Database of Systematic Reviews and Implementation Reports, and no systematic reviews were found on this topic.

    A physiotherapy-guided self-management approach has been reported as the best intervention for chronic disease including chronic low back pain, and it also improves clinical disease parameters (eg, improvement after stroke) and lowers the cost when the patients are actively participating in an SMP.17 18 Despite the importance of physiotherapy-guided self-management interventions, there is a dearth of studies done on this topic, particularly on the effectiveness of physiotherapy-guided self-management interventions for CLBP in LMICs.19 The systematic review on the effectiveness of physiotherapy-guided self-management may therefore benefit the patients with CNLBP in LMICs by improving their condition and reducing the costs of hospital visits. The findings of the current systematic review will be used to guide the development of a physiotherapy-guided SMP for people with CNLBP in LMICs.

    Aim

    The aim of this systematic review is to investigate the effectiveness of existing physiotherapy-guided self-management interventions on pain and disability outcomes for adults (>18 years) with CNLBP living in LMICs.

    Objectives

    • To determine the effectiveness of physiotherapy-guided self-management interventions on outcomes (pain, disability, self-efficacy, and quality of life) for adults with CNLBP living in LMICs?

    • To determine if there are differences in effectiveness, depending on the components of physiotherapy-guided self-management interventions for adults with CNLBP living in LMICs?

    • To determine if there are differences in effectiveness depending on participant characteristics such as age and gender?

    Methods

    Protocol design, reporting and registration

    The systematic review will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines for systematic reviews, which comprises eligibility criteria (participants, interventions, comparators, outcomes and context), search strategy, study selection, assessment of methodological quality, data extraction, synthesis and assessing certainty in the findings.20 (Refer to the supplementary documents, online supplemental appendix 1) This systematic review is registered with the international database of a prospectively registered systematic review with a health-related outcome (PROSPERO) for the benefit of peer review, reducing duplication effort and increasing the transparency of research.21 The registration number for this review protocol on PROSPERO is CRD42023399572.

    Eligibility criteria

    Type of studies

    Any study published from the onset to the current date that has information on the effectiveness of physiotherapy-guided self-management interventions for CLBP among adults in LMICs will be included in this study such as experimental study designs, randomised controlled trials ((RCTs) with concealed allocation), pseudo randomised control trials (RCT without concealed allocation), non-RCTs and quasi-experimental studies (experimental study without randomisation).

    Studies will be included without language restrictions. Descriptive and correlational quantitative research, qualitative studies and clinical guidelines will be excluded from this study.

    Expert opinions and published systematic reviews will only be used for bibliographic checks to ensure that any eligible studies are not omitted.

    Study setting

    Only studies that are conducted in LMICs as defined by the World Bank will be included.

    Study participants

    All studies that include adults who are 18 years of age and older with CNLBP will be included in this study.

    Types of interventions

    Physiotherapy-guided self-management strategies for the management of CNLBP that follow a biopsychosocial approach will be considered, for example, pain neuroscience education (PNE), digital health intervention (DHI), behaviour change theory (brief motivational interviewing), physiotherapy training (including physiotherapists who will administer the SMP to patients) and various forms of exercise training.22–25 The intervention can be a prescribed education programme, physiotherapy-led intervention or a multidisciplinary intervention that targets an individual or a group of individuals. The biopsychosocial approach in physiotherapy-guided self-management entails a therapist using a combination of biological, psychological and social factors in treatment. The biological aspect may involve exercises, activities or self-treatment methods such as heat therapy. On the contrary, the psychosocial component focuses on educating and empowering patients to enhance self-efficacy, self-control and self-responsibility. This may also involve exposure to feared activities, encouraging social participation and other related interventions. The non-physiotherapy treatment regime (outside the scope of physiotherapy profession interventions) either used as the intervention or control will be excluded.

    Types of control

    The intervention should be compared with the standard of care (no treatment or intervention or no change in usual activities of care).

    Types of outcomes

    Primary outcome

    Self-efficacy (self-efficacy scale), Patient-Specific Functional Scale and Health-Related Quality of Life (HRQL).

    Secondary outcome

    Pain (Visual Analogue Scale or Numerical Pain Rating Scale) and disability (Oswestry or modified Oswestry, Roland Morris, and Quebec disability).

    Definitions of concepts

    Physiotherapy-prescribed SMPs as an intervention in CNLBP can be described in different terms which include a biopsychosocial approach, rehabilitation and standard treatment guidelines ((STGs) examples of interventions include home exercise programmes).

    • Chronic non-specific low back pain is defined as LBP that persists for at least more than 3 months excluding known specific pathology and includes both RLBP and PLBP.

    • Self-management is a set of tasks performed by the patient aimed at managing their symptoms, and interference in activities, mood and relationships due to pain.25 A physiotherapy-guided SMP comprises both biomedical and psychosocial elements, where the biomedical elements tend to be the current standard of care approach.

    • Rehabilitation is the process across the continuum of care in the lifespan of a person with a disability that aims to maximise function and participation in key aspects of life within the individual environment.26 This process can include patient-orientated therapy, exercise training, family support, counselling, modification of the environment and self-management strategies.

    • STGs are systematically developed statements to help practitioners or prescribers decide about treatments to be used for specific clinical conditions.27 This includes information on clinical features, diagnostic criteria, non-drug and drug treatments (first, second and third line), as well as referral criteria.

    • The biopsychosocial approach is an approach to delivering treatment for conditions that incorporates biological, psychological and social factors. This approach views health and illness as the product of biological characteristics (genes), behavioural factors (lifestyle, stress, health beliefs) and social conditions (cultural influences, family relationships, social support).28

    Search strategy

    The information sources will be searched from different databases at two levels: (1) electronic database searching and (2) physical searching from the reference lists and citations of the included sources. The electronic databases will include PubMed, MEDLINE, SPORTDiscus, Scopus and CINAHL, Academic Search Complete and PEDro. A pilot search was conducted on 21 February 2023 from the period of inception to date and this will be refined to establish the final search strategies for the respective databases. Physical hand-searching for all included sources and reference lists for all included studies will also be conducted. The search will not be limited by language and where necessary services of a translator will be utilised. The absence of an inception date for searches is chosen to be appropriate in this systematic review based on the limited studies done on physiotherapy-guided self-management for adults with CNLBP in LMICs.15

    The search strategies will be drafted with the assistance of the co-author (KK), an experienced information specialist. During the process of drafting, other information specialists will conduct a peer review using the Peer Review of Electronic Search Strategies (PRESS) checklist.29 The recommendations from the other information specialists and systematic review experts will be taken into consideration during the refining or amending of the final search strategies.

    A three-step search strategy will be used to search the databases. The initial search of Academic Search Complete, MEDLINE PubMed, EBSCOhost, Scopus and CINAHL will be conducted, followed by an analysis of the text words in the title and abstract of the retrieved papers and of the index terms used to describe the articles. A second search using all identified keywords and index terms will then be undertaken across all included databases. Third, the reference lists of all identified reports and articles will be searched for additional relevant studies. If more information is required from the selected studies, the authors of primary studies or reviews will be contacted. A pilot search was conducted in Academic Search Complete to identify the possibility of conducting the proposed systematic review (refer to table 1).

    View this table:
    Table 1

    Results of pilot search strategy

    Study selection

    Following the database search, articles with relevant titles will be exported to an Endnote 20 library and duplicates will be removed. Screening will be conducted using Rayyan, a web-based systematic review software.30 The screening will be conducted by two independent reviewers. Initially, a calibration exercise will be employed to ensure that the inclusion and exclusion criteria are clear for all screeners. The first 10 articles will be screened and agreement assessed before proceeding with all of the articles. We will begin with the title and abstract screening. Disagreements at this stage will be resolved through discussions by the two reviewers until a consensus is reached. We will then proceed with full article screening for the included articles. Disagreements at this stage will be resolved by inviting a third reviewer to make a final decision on inclusion or exclusion of the conflicting articles among the two reviewers. The studies that do not meet the inclusion criteria will be excluded, and the reason for the exclusion will be stated. The process of study selection will be presented in the PRISMA flow diagram attached in figure 2.20

    Figure 2
    Figure 2

    Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocol flow diagram.

    To determine the inter-rater level of agreement between the two reviewers, Cohen’s kappa statistic will be calculated. The kappa statistic will be interpreted as follows: <0.1 will represent no agreement and 0.10–0.20 will represent none to the slight agreement, 0.21–0.40 will represent fair agreement, 0.41–0.60 will represent moderate agreement, 0.61–0.80 will represent substantial agreement and 0.81–1.00 will represent almost perfect agreement.

    Assessment of methodological quality

    A Cochrane Collaboration revised tool of Risk of Bias (RoB 2.0) will be used by two reviewers to assess the RoB independently for all the included studies. If there is disagreement, a third reviewer will be consulted. The RoB 2.0 tool covers five domains: (1) randomisation sequence, (2) allocation concealment, (3) blinding, (4) completeness of outcome and (5) selective outcome reporting, and it also classifies the studies into the low, high or unclear RoB.31 The non-randomised controlled trial (NRCT) will be assessed using the ROBINS-I tool, given that it is particularly useful for systematic reviews that include NRCT studies of intervention.32 This tool is guided through seven chronologically arranged bias domains at pre-intervention, intervention and post-intervention, and the interpretation of domain level. Overall bias risk judgement in ROBIN-I is classified as low, moderate, serious or critical RoB.32 The two independent reviewers will assess and score the selected studies, and disagreements will be resolved by the third reviewer. The narrative summary of the risk bias for each outcome across individual studies will be reported in tabular form.

    Data extraction

    A data extraction form will be developed and piloted before implementation. The data extracted will include specific details about the participants (ie, age, sex), intervention (ie, self-management, biopsychosocial), context, outcomes (pain, disability, self-efficiency, HRQL), study design methods, year of publication, country of publication and key findings relevant to the review question. Data extraction will be conducted independently by two reviewers, and for any disagreements, a third reviewer will act as the moderator in the discussion.

    Processes of data extraction

    We will focus on the common outcomes examined within the included studies to identify RCTs that we can synthesise to identify generic and specific effects of physiotherapy SMP across and within health problems (CNLBP). The primary and secondary outcomes will be priorities for the long-term effects of physiotherapy-guided SMP on pain, disability, self-efficacy and HRQL outcomes. Where no long-term follow-up outcomes data are available, we shall present the longest follow-up point available or the time point where the meta-analytic synthesis was performed. If there are separate analyses for several measurements of the same outcome, then we will choose the analysis with the largest number of RCTs included. If they are equal, then we will select the analysis of the measurement with the best outcome properties. If, in addition to or instead of pain, disability, HRQL and self-efficacy there are multiple physiotherapy-guided SMP outcomes, we will make a list of all available outcomes reported. If we find an additional common outcome, deemed meaningful to improve an individual’s function or physical activities, which we have not focused on, we will return to the review and extract this information.

    We will group all the reviews that include pain, disability, self-efficacy and HRQL outcomes together. From these, we shall identify those that have performed a meta-analysis of the data. These reviews shall be grouped by type or method of physiotherapy-guided SMP (ie, PNE, DHI and rehabilitation). At this stage, we shall check if any of the included systematic reviews, within a health problem category (CNLBP), share primary RCTs. If we identify two or more reviews that are eligible for inclusion but share the same primary RCTs, we will use the following criteria hierarchy to choose one review for inclusion. We shall return to the full text of the reviews that were selected and extract effect sizes, CIs and heterogeneity measures. For effect sizes based on continuous outcome measures, the combined intervention/control group means, SD and the total number of participants per group shall be extracted. For binary outcomes, we shall extract from the combined intervention/control group the number of participants who have achieved the desired outcome plus the total number of participants. The selected reviews will be examined to identify those with moderate clinical, design and statistical homogeneity.

    Subgroup analysis

    For each of our key outcomes (pain, disability, self-efficacy, HRQL and the most common physical outcome), we will perform a subgroup analysis comparing: (1) articles that include RCTs with high-intensity physiotherapy-guided SMP, (2) those with low-intensity physiotherapy-guided SMP, (3) those with a mixture of high-intensity and low-intensity physiotherapy-guided SMP RCTs. In addition, if we find articles that directly compare high-intensity and low-intensity physiotherapy-guided SMP within the review, we shall group these and if possible, pool the results, comparing high-intensity to low-intensity physiotherapy-guided SMP groups rather than intervention to control groups. We do not plan to perform any further subgroup analyses; however, if the data are suitable, we are flexible with additional analyses for example, control group type or follow-up period.

    Data synthesis

    The RoB assessment may be incorporated into synthesis by performing sensitivity analysis. A descriptive analysis will be conducted for all the included studies and will be presented in tabular form based on the categories, such as year of publication, countries of origin, outcomes, and research methods if appropriate.

    Based on our knowledge of the self-management literature, we anticipate heterogeneity among the intervention types, components and outcomes, which will potentially limit pooled analysis. The standardised mean difference (SMD) of the numerical scores for self-effficacy, HRQL, pain and disability outcomes will be used to compare across studies. Meta-analysis will be applied using the intention-to-treat principle, where appropriate for instance if a group of studies has sufficient comparable interventions and outcomes and performed in similar settings. In the case of categorical data, the risk ratio (RR) will be considered for effect size.33 The SMD will be categorised as small, medium and large based on the thresholds 0. 2, 0. 5 and 0. 8, respectively, as per Cohen’s suggestion.34

    We will use a 95% CI to present the deviation from the point of estimate for both individual and grouped study estimates. The heterogeneity between the studies will be assessed by using the I2 statistic and the χ2 test (p<0.1 will be considered significant).35 The random effects model of meta-analysis will be used to take account of the potential heterogeneity. We will evaluate the possibility of publication bias by use of funnel plots and by conducting Egger’s test for analyses that contain more than 10 studies.36 All analyses will be done using Stata V.17 statistical software.

    Confidence in cumulative evidence

    The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to determine the quality of evidence for making recommendations on the effectiveness of physiotherapy-guided self-management interventions for adults with CNLBP.37 This process will be done by the two reviewers and in the case of disagreement, the third reviewer will be involved.

    Patient and public involvement

    There is no patient or public involvement. Only physiotherapists working in a middle-income country were consulted in the development of this proposal.

    Ethics and dissemination

    Ethical approval and consent for this systematic review protocol are not applicable. This systematic review protocol was, nevertheless, approved as part of a PhD umbrella study aimed at a physiotherapy-guided SMP for adult people with CNLBP in Limpopo Province, South Africa (Ethics reference no: 514/2021 refer to the supplementary documents, online supplemental appendix 2). The published article is to be uploaded to academic, and public science, repositories and presented at conferences, symposia and congresses.

    Discussion

    Despite the fact that self-management for chronic low back pain has been broadly reported as an effective approach, there are knowledge gaps and a lack of standardised approaches to the self-management of affected adult people in LMCs. Identifying the effectiveness of physiotherapy-guided self-management interventions for chronic low back pain important, considering the burden related to chronic low back pain, globally and including LMICs.

    This systematic review will assist in updating the knowledge on the effectiveness of physiotherapy-guided self-management interventions since we aim to explore the setting of LMICs where adults receive healthcare services. Our results will be underwritten through the rigorous methodology provided by the Cochrane handbook, and the results will be reported as stipulated by the PRISMA statement. This systematic review will therefore provide the relevant knowledge that will guide, influence or facilitate the implementation of better treatment regimens for the current and future of physiotherapy-guided self-management interventions for people with chronic low back pain in LMICs. Notwithstanding the benefits, the evidence of this systematic review may be limited by the quality of the individual studies and by the limited number of studies available or even may not provide a complete picture, given that the systematic review is but one methodology in a slate of research possibilities.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    The authors would like to thank the physiotherapists in Limpopo Province, South Africa, for their assistance with the strengthening of the search strategy.

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    Supplementary materials

    • Supplementary Data

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    Footnotes

    • X @GivenSergant, @MaureenMoyo2

    • Contributors SGM, MM-C, AM and NN conceptualised the protocol. SGM wrote the first version of the protocol and acting as guarantor. MM-C and AM assisted with the refinement of the protocol methods and KK with the search strategy. KM and NN critically revised the manuscript. All authors approved the final version.

    • Funding A grant was obtained from the Ernest and Ethel Eriksen Trust (ITRUST 11110/05). The funders will not play any role in the review process. The authors will be solely responsible for all statements and reviews to be made.

    • Disclaimer All the statements and reviews to be made will be solely the responsibility of the author.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.