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Most physical interventions for musculoskeletal pain in children and adolescents cannot be reproduced in clinical practice: a meta-research study of randomized clinical trials

BMC Musculoskeletal Disorders volume 25, Article number: 698 (2024) Cite this article

Abstract

Introduction

Conservative treatments such as physical therapies are usually the most indicated for the management of musculoskeletal pain; therefore, a detailed description of interventions enables the reproducibility of interventions in clinical practice and future research. The objective of this study is to evaluate the description of physical interventions for musculoskeletal pain in children and adolescents.

Methods

We considered randomized controlled trials that included children and adolescents between 4 and 19 years old with acute or chronic/persistent musculoskeletal pain. We included physical therapies related to all types of physical modalities aimed at reducing the intensity of pain or disability in children and adolescents with musculoskeletal pain. The description of interventions was assessed using the Template for Intervention Description and Replication (TIDieR) checklist. We performed electronic searches in the following databases: CENTRAL, MEDLINE, EMBASE, CINAHL, PsyINFO and PEDro up to April 2024. The description of physical interventions was presented using frequencies, percentages and 95% confidence intervals (CIs) of the TIDieR checklist items described in each study. We also calculated the total TIDieR score for each study and presented these data as mean and standard deviation.

Results

We included 17 randomized controlled trials. The description measured through the TIDieR checklist scored an average of 11 (5.2) points out of 24. The item of the TIDieR that was most described was item 1 (brief name) and most absent was item 10 (modifications).

Conclusion

The descriptions of physical interventions for the treatment of musculoskeletal pain in children and adolescents are partially described, indicating the need for strategies to improve the quality of description to enable true clinical reproducibility.

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Introduction

Children and adolescents present a prevalence of musculoskeletal pain of 27.1% [1] to as high as 40% [2, 3]. Musculoskeletal pain in children and adolescents leads to school absenteeism, use of medication, poor levels of physical activity, and poor quality of life [4], which is also responsible for the highest need for rehabilitation services among children and adolescents, and increases the risk of becoming adults with chronic pain [5,6,7]. Conservative treatments are the most commonly used for the management of chronic pain in children and adolescents, including active and passive interventions, as most commonly described in randomized controlled trials, [8] and therefore a detailed description must be adopted for replication in clinical practice.

Although there is a need for well described randomized controlled trials to be replicated in practice, those descriptions are not often well reported [9]. For example, previous studies have found that only 39% of non-pharmacological interventions were adequately described [9] and only 20% of evidence-based practice educational interventions were adequately reported after contact with the authors [10]. For instance, a recent study assessed the quality report using the Template for Intervention Description and Replication (TIDieR) checklist in remote cardiac rehabilitation, and the mean score was 8 out of 12 and interesting no study provided a full report of the intervention protocol. Specifically in this case, interventions like cardiac rehabilitation can reduce morbidity and save lives, however without an adequate description, they cannot be replicated [11]. Similar results were presented in different conditions, such as hip osteoarthritis [12], stroke [13], and cancer [14]. Thus, an inadequate description of interventions disables replication and implementation in clinical practice and could increase the waste in research [15, 16].

Based on this, checklists were created with the aim of improving the quality of reports, such as Consolidated Standards of Reporting Trials (CONSORT) for clinical trials, and the (TIDieR) [15, 17]. The aim of the TIDieR is to assist authors to fully describe interventions, and a TIDieR total score has been suggested to quantify how adequate the intervention descriptions are [18]. Therefore, the TIDieR checklist can contribute to the replication of interventions in clinical practice [19]. Clinicians and decision makers use the available evidence to guide treatment, however, for this to be possible, they need to know how, where, and what was done. Although studies show the benefits of exercise, [20, 21] we do not know if they’re adequately reported and therefore, whether they can be replicated. Without detailed and robust evidence, we cannot provide the best treatment for children and adolescents.

However, no study has evaluated the completeness of the description of physical interventions using the TIDieR checklist, specifically for children and adolescents with musculoskeletal pain. Therefore, we do not know whether randomized controlled trials in this population provide the necessary information to implement those interventions in clinical practice. Thus, this study aims to evaluate the description of physical interventions for musculoskeletal pain in children and adolescents.

Methods

Study design

A meta-research study was carried out to evaluate the description of physical interventions for the treatment of musculoskeletal pain in children and adolescents. The protocol of this systematic review was published in the Open Science Framework (OSF) (https://osf.io/6qa4j/).

Eligibility criteria

Study design

We included randomized controlled trials that aimed to deliver physical interventions for children and adolescents to reduce acute, persistent, or recurrent musculoskeletal pain.

Participants

As the interest of the study was methodological, we considered randomized controlled trials that included children and adolescents between 4 and 19 years old with pain regardless of duration (acute, subacute or chronic/persistent pain) [22]. This study considered acute pain as less than three months, subacute pain as 7–12 weeks, and chronic/persistent pain as persistent pain for more than three months [22, 23]. We included musculoskeletal pain, as well as generalized pain/fibromyalgia, neuropathic pain, and complex regional pain syndrome. Studies with types of mixed pain, such as abdominal pain, were only considered if musculoskeletal pain data were presented separately or if musculoskeletal pain corresponded to at least 75% of the sample. Studies with a mixed population of children and adults were considered if data from children and adolescents were presented separately, if the mean age was less than 19 years or if at least 75% of the sample was less than 19 years. We excluded studies with pain due to specific conditions (e.g., juvenile idiopathic arthritis, headache, and migraine), trauma, fracture, sports injuries, and post-surgery. We excluded asymptomatic conditions where pain or disability was not the primary outcome, such as scoliosis and benign joint hypermobility [24].

Interventions

Active interventions involving body movement and a variety of physical therapies, such as conservative exercise, aerobic training, yoga, and hydrotherapy, were considered. Studies evaluating integrative medicine, such as Tai Chi, acupuncture, and passive interventions, such as spinal manipulation therapy, massage, and electrotherapy, were also considered. We excluded studies of drugs, invasive interventions, surgery, and physical interventions associated with multicomponent interventions or psychological interventions in which the effect of physical intervention cannot be assessed in isolation, such as exercise and cognitive‒behavioral therapy versus usual care.

Comparator

We considered studies whose comparators were usual care, waiting list or minimal intervention (e.g., counseling), relaxation classes, or social group meetings. We only included active intervention as a comparator if the effect of the main intervention could be isolated (e.g., exercise and spinal manipulation versus exercise).

Outcome

We considered studies with patient-centered primary outcomes (e.g., pain intensity, function, health-related quality of life).

Search strategy

The search strategy was conducted in the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via OvidSP), EMBASE (via OvidSP), Cumulative Index for Nursing and Allied Health Literature (CINAHL) (via EBSCO), PsycINFO (via OvidSP) and Physiotherapy Evidence Database (PEDro). The search strategy was conducted in April 2024. MeSH terms or equivalent and text word terms were used, and we adjusted searches for each database. There were no restrictions regarding the year of publication or language. Only trials published in peer-reviewed journals were eligible for inclusion. Search results were imported and managed using EndNote software version X9 [25]. The details of the completed search strategy are presented in Appendix 1.

Searching in other resources

We manually searched the reference lists of the included studies and relevant systematic reviews to identify potentially eligible studies.

Study selection

The study selection process (title, abstracts, and full-text screening) was performed by three pairs of reviewers (CMES and CGF; MNL and EVM; VSS and JSA) to determine potentially eligible studies that met our inclusion criteria. Disagreements were resolved by discussion between reviewers. In cases where consensus could not be reached, a third reviewer (TPY) arbitrated.

Data extraction

Data extraction was performed by the same three pairs of reviewers (CMES and CGF; MNL and EVM; VSS and JSA). A meeting was held before starting the data extraction to align the concepts. Any disagreements were resolved by discussion, or a third reviewer (TY) arbitrated.

The following information was taken from the included studies: bibliometric data (authors, year of publication, language); study characteristics (study design, sample size, sample description, country, year(s) and recruitment procedure, conflict of interest, funding source); characteristics of participants (sex, age, condition, duration of pain); description of the intervention setting (experimental and control); evaluation of the description of interventions for the intervention and control groups according to the TIDieR checklist; and, outcomes reported (e.g., pain intensity, health-related quality of life, disability).

For the information that was unavailable in the manuscript, we did not contact the study’s authors due to the aim of this review.

Template for Intervention Description and Replication (TIDieR) checklist

The TIDieR checklist is a valid and well-recognized guide to write the description of interventions [19]. The TIDieR checklist is composed of 12 items: 1) brief name; 2) why; 3–4) what; 5) who provided; 6) how; 7) where; 8) when and how much; 9) tailoring; 10) modifications; and 11–12) how well. Items 3 (what), 6 (how) and 8 (when and how much) have subitems, resulting in a total of 17 elements (counting the checklist items and subitems). (Appendix 2). Although the TIDieR checklist was developed as a checklist to help authors to fully describe the interventions, a TIDieR total score has been suggested to quantify how adequate the intervention descriptions are [18]. The use of the TIDieR total score could complement the checklist as suggested previously [18]. For the TIDieR total score, each item is scored as ''yes'', ''no'' or ''not applicable''. The 'not applicable' option is only used for control groups where no treatment was delivered. For the items that were applicable, 1 point was assigned if the intervention group scored ‘yes’ and 0 if it scored ‘no’ [18]. The evaluation of each item is suggested to be performed on a 3-point Likert scale with the following categories: not reported (0), partially reported (1), and adequately reported (2) [18]. If the item was described only for one of the two groups (intervention or control) or if any of the subitems (referring to items 3, 6, and 8) were not described, only 1 point is attributed [18]. The total score is calculated by adding the score (0, 1 or 2) of each 12 items for both groups (intervention and control), so the total score can range from 0 (poor description) to 24 (complete description) points. However, the TIDieR checklist does not have a cut-off point, therefore, the final score was used for the overall description. [18]

Data analysis

The characteristics of the included studies and the sample are summarized in Table 1. The description of the interventions through the evaluation of the TIDieR checklist was presented descriptively with the total results presented as the mean and standard deviation and 95% confidence intervals. For each individual TIDieR item, the frequency, percentage and 95% confidence intervals (CIs) of each item were reported. All data were analyzed using Microsoft® Excel® 2013 software for Windows.

Table 1 Characteristics of the included studies
Full size table

Results

From 25,791 studies identified through the search, 17 randomized controlled trials were eligible for this review. The details of the study selection and reason for exclusion are presented in the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) flow diagram in Fig. 1. There was one included study (5.9%) in each country: Australia, South Africa, Portugal, Korea, Canada, Egypt, United Kingdom, India, Brazil, Saudi Arabia, Sweden, and Netherlands, two studies in Denmark (11.8%); and three studies in the United States of America (17.6%). The sample of the included studies totaled 1,571 participants, with a mean age of 14.9 (2.2). Most of the participants were female and most of the recruitment procedures were carried out in schools. The most evaluated pain conditions were low back pain and neck pain (Table 1).

Fig. 1
figure 1

PRISMA flow diagram for the inclusion process

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Assessment of the description of interventions using the TIDieR checklist for the intervention and control groups

From all included studies, the final TIDieR score ranged from 3 to 22 points and presented a mean of 11 (5.2) points (Table 2). The individual TIDieR items that were more adequately reported were item 1 – brief name (n = 33; 97% (85.1 to 99.5); item 4 – what (procedures) (n = 25; 73.5% (56.9 to 85.4) and item 6 – how (n = 24; 70.6% (53.8 to 83.2) (Fig. 2). The TIDieR items that missed a description were item 10 – modifications (n = 0; 0% (0 to 10.1); item 12 – how well – actual (n = 3; 8.8% (3.0 to 23.0); and item 11 – how well – planned (n = 7; 20.6% (10.3 to 36.8) (Fig. 2). Table 2 shows the TIDieR total score for each included study for both the intervention and control groups and for the total score considering the intervention and control groups together.

Table 2 TIDieR checklist and total score for the intervention and control groups
Full size table
Fig. 2
figure 2

The overall TIDieR percentage of the intervention and control group

Full size image

Discussion

Main findings

According to our findings, only 49% of the TIDieR items were full fielded by all clinical trials in children and adolescents with musculoskeletal pain. None of the trials met all the TIDieR checklist criteria.

The TIDieR items most described was item 1 (brief name), this item is fulfilled if presented a concise and clear label of the intervention, while being a relatively basic item, it still was not present in all the studies. Item 4 (what -procedures) received a high report (73.5%), this item provides crucial information for the implementation of the intervention. Although the items 12 (how well – actual) and 11 (how well – planned), where poorly described, we considered them less relevant since they do not describe how the intervention was performed, and that could be a justification for a lower report. Item 10 (Modifications) was that most inadequately described, and item 9 (Tailoring) was only reported by 35.3% of the studies. Individualized interventions consider a person's demands, preferences and conditions to design interventions, including behavior modification, and exercise parameters [26,27,28]. These interventions are becoming more common, and so tailoring and modifications are expected, thus they should be based on guiding principles, for example: A systematic review found that the interventions that were more effective, were behavioral interventions, face-to-face and individualized [29]. However, the methods of the interventions included were not reported, making it difficult to ascertain whether the tailored interventions were given as intended and what the key components were [29].

The reporting of the interventions for the included studies had an average of 11 out of 24 points. The difference between the intervention and control groups was one point. The control group had a score of 5 out of 12. Despite similar results, it is important to give attention to the description of the control group, that had lower scores. The characteristics of usual care or an active control intervention when not appropriately matched to experimental interventions, may result in an over or underestimated benefit and harm in the trial [30]. Thus, there should be a clear description of the control intervention, even though all the TIDieR items apply for both the intervention and the control group, the control group are not usually adequately described.

Comparison with existing literature

Previous studies have assessed the completeness of the description in physical therapy interventions, [11,12,13,14] and reported that most interventions are inadequately reported. Descriptions of control interventions were even worse, which was also in accordance with our findings [31]. In our findings, item 10 (Modification) did not score in any of the included studies, this finding as intriguing at it may seem, correlates with the literature in which a study analyzed report quality in two time periods: 2002–2007 (before the CONSORT extension statement of reporting guidelines) and 2010–2015. In the first time period, 42 studies were included and only one met the criteria for modifications. In the second time period, from 134 studies, four met the criteria. Although these studies may not have been modified, it is important to clearly ensure that no changes were made [32].

Although the TIDieR checklist was developed in 2014, an action was initiated in 2016, where editorials published in the most important journals of physical therapy highlighted the importance of the use of the TIDieR checklist [33]. On the other hand, one year later a survey found that from 59 of the leading pathology journals, only one required the submission of a guideline reporting checklist [34]. A previous study comparing the differences between 2000 and 2018, found that some items have improved. Item 3 (materials), for example, had a 29% improvement in report completeness, whereas item 6 (How) improved by 22% between years. This is consistent with our study’s findings as the item 6 (How) was reported in 70.6% of the included studies, making it one of the items with the highest report completeness [35]. Although these items have shown improvement, the mean score for physical therapy interventions did not significantly change since the development of the TIDieR. [35] Despite the action taken in 2016 to improve the description of interventions, [33] eight years later, our findings show that it seems we still face the same problem.

A recent systematic review of physical activity in children and adolescents for example, included four studies, comparing physical activity with usual care [36]. However, due to the very low-certainty evidence the authors were unable to conclude that the interventions were effective in improving pain. Additionally, another study evaluating the methodological quality and reporting of non-pharmacological interventions in children and adolescents [37] found that 94% of the 17 systematic reviews included were rated as “critically low” and “low” methodological quality by A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2), raising concerns about the reliability of the evidence clinicians use for decision-making. This highlights the critical need for well-reported clinical trials. While we may know exercise offers some pain relief benefits, robust research is needed to determine the most effective type, dosage, and delivery method (eg, individual vs. group) for optimal outcomes. Only with robust and well-described evidence we can provide a better treatment guide for children and adolescents with pain.

If researchers are unable to comprehensively report all aspects of the interventions, the trial results may not be incorporated into clinical practice, or the intervention may be implemented incorrectly or with low fidelity, making them unusable [38]. Additionally, the replication of the intervention in randomized controlled trials is not possible in other settings or populations. This implies an unplanned waste of tens of billions of dollars of investment in research every year for problems that could be corrected [16]. This study then allows us to understand of what specifically needs to be improved in the description of randomized controlled trials to possibly guide practice and future studies.

Strengths and limitations

This study is the first to assess the reporting quality of interventions in children and adolescents with musculoskeletal pain. We selected the main electronic databases in the field of physical therapy to reach a greater number of relevant studies. We used the TIDieR checklist, which is a checklist developed to guide authors on better report descriptions of interventions [18, 19].

A limitation of this study was the exclusion of multicomponent interventions; however, it brings us to a reflection: if interventions with only one component already showed bad results, would including interventions with multiple components decrease even more the quality of reporting?

Recommendations

The results of this study make a call for action to future randomized controlled trials which included children and adolescents enhance their report quality. The responsibility for improving the intervention reports extends to clinical trial authors who should use the TIDieR checklist to guide their descriptions. The responsibility also extends to the editors and reviewers that could request the checklists, such as CONSORT and TIDieR at the time of submission to guarantee the publishing of reproductive studies. We believe we still need strategies to enhance the reporting of research. We recognize that many journals have word limits, a possible solution could be the publication of the study protocol, with a complete description of the intervention or attaching an appendix of the details of the intervention. For more complex interventions, the use of videos or websites could also be attached as a supplementary material. These are only some strategies that can improve reproducibility and reduce waste in research.

Conclusion

The overall description of physical interventions for musculoskeletal pain in children and adolescents presented a mean of 11 out of 24 points, which means only 49% of all items were full field and none of the articles met all the TIDieR checklist criteria. Despite previous studies with different conditions and actions to enhance a better reporting of clinical trials in general, a complete description of interventions for children and adolescents with musculoskeletal pain remains scarce, indicating the need for specific strategies to improve the quality of the description of these items in physical interventions to enable clinicians and researchers to replicate the interventions.

Deviation from protocol

The original version of the protocol only considered as a comparator usual care, waiting lists or minimal intervention (e.g., counseling), relaxation classes, or social group meetings. However, as we found only a few studies, we decided to also include active intervention as a comparator if the effect of intervention could be isolated. The original version of the protocol proposed to search in ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registration Platform (ICTRP: apps.who.int/trialsearch). However, as we are interested in published studies only, we did not perform these searches.

Availability of data and materials

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

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Acknowledgements

We would like to thank Lucas H.C.C. Santos for providing valuable comments and suggestions, which greatly enriched the interpretation of our results.

Funding

This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior—Brasil (CAPES)—Finance Code 001.

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Authors and Affiliations

  1. Master’s and Doctoral Program in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, Brazil

    Carolina G Figueiredo, Verônica S Santos, Eduarda Vianna Madureira, Jéssica Silva Antunes, Caique do Espirito Santo, Mariana N Leite & Tiê P Yamato

  2. Faculty of Medicine and Health, The University of Sydney, Sydney, Australia

    Tiê P Yamato

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  1. Carolina G Figueiredo
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  6. Mariana N Leite
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  7. Tiê P Yamato
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Contributions

TPY: Conceptualization, methodology, reviewing and editing. CGF, EVM, JSA and VSS: data collection, analysis, methodology and reviewing, conceptualization, methodology, reviewing and editing. CMES and MNL: data collection, analysis, methodology and reviewing. All authors read and approved the final manuscript.

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Correspondence to Tiê P Yamato.

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The protocol of this systematic review was published in the Open Science Framework (OSF) (https://osf.io/6qa4j/).

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Figueiredo, C.G., Santos, V.S., Madureira, E.V. et al. Most physical interventions for musculoskeletal pain in children and adolescents cannot be reproduced in clinical practice: a meta-research study of randomized clinical trials. BMC Musculoskelet Disord 25, 698 (2024). https://doi.org/10.1186/s12891-024-07668-8

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Keywords

BMC Musculoskeletal Disorders

ISSN: 1471-2474

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