Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial

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Abstract

Objectives

The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal.

Design

A two-arm, parallel, assessor-blinded, feasibility RCT.

Setting

A rehabilitation hospital in Kathmandu, Nepal.

Participants

Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women).

Interventions

Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session.

Primary outcome measures

The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment.

Secondary outcome measures

Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation.

Results

Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported.

Conclusion

We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted.

Trial registration number

NCT03387228; Results.

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Most cited references 58

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International physical activity questionnaire: 12-country reliability and validity.

CORA L. CRAIG, ALISON L. MARSHALL, MICHAEL SJ??STR??M … (2003)

Physical inactivity is a global concern, but diverse physical activity measures in use prevent international comparisons. The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. Between 1997 and 1998, an International Consensus Group developed four long and four short forms of the IPAQ instruments (administered by telephone interview or self-administration, with two alternate reference periods, either the "last 7 d" or a "usual week" of recalled physical activity). During 2000, 14 centers from 12 countries collected reliability and/or validity data on at least two of the eight IPAQ instruments. Test-retest repeatability was assessed within the same week. Concurrent (inter-method) validity was assessed at the same administration, and criterion IPAQ validity was assessed against the CSA (now MTI) accelerometer. Spearman's correlation coefficients are reported, based on the total reported physical activity. Overall, the IPAQ questionnaires produced repeatable data (Spearman's rho clustered around 0.8), with comparable data from short and long forms. Criterion validity had a median rho of about 0.30, which was comparable to most other self-report validation studies. The "usual week" and "last 7 d" reference periods performed similarly, and the reliability of telephone administration was similar to the self-administered mode. The IPAQ instruments have acceptable measurement properties, at least as good as other established self-reports. Considering the diverse samples in this study, IPAQ has reasonable measurement properties for monitoring population levels of physical activity among 18- to 65-yr-old adults in diverse settings. The short IPAQ form "last 7 d recall" is recommended for national monitoring and the long form for research requiring more detailed assessment.

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Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

T C Hoffmann, P P Glasziou, I Boutron … (2015)

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

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Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016

Yuan-Pang Wang, Maheswar Satpathy, Mathilde Touvier … (2018)

Summary Background As mortality rates decline, life expectancy increases, and populations age, non-fatal outcomes of diseases and injuries are becoming a larger component of the global burden of disease. The Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) provides a comprehensive assessment of prevalence, incidence, and years lived with disability (YLDs) for 328 causes in 195 countries and territories from 1990 to 2016. Methods We estimated prevalence and incidence for 328 diseases and injuries and 2982 sequelae, their non-fatal consequences. We used DisMod-MR 2.1, a Bayesian meta-regression tool, as the main method of estimation, ensuring consistency between incidence, prevalence, remission, and cause of death rates for each condition. For some causes, we used alternative modelling strategies if incidence or prevalence needed to be derived from other data. YLDs were estimated as the product of prevalence and a disability weight for all mutually exclusive sequelae, corrected for comorbidity and aggregated to cause level. We updated the Socio-demographic Index (SDI), a summary indicator of income per capita, years of schooling, and total fertility rate. GBD 2016 complies with the Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER). Findings Globally, low back pain, migraine, age-related and other hearing loss, iron-deficiency anaemia, and major depressive disorder were the five leading causes of YLDs in 2016, contributing 57·6 million (95% uncertainty interval [UI] 40·8–75·9 million [7·2%, 6·0–8·3]), 45·1 million (29·0–62·8 million [5·6%, 4·0–7·2]), 36·3 million (25·3–50·9 million [4·5%, 3·8–5·3]), 34·7 million (23·0–49·6 million [4·3%, 3·5–5·2]), and 34·1 million (23·5–46·0 million [4·2%, 3·2–5·3]) of total YLDs, respectively. Age-standardised rates of YLDs for all causes combined decreased between 1990 and 2016 by 2·7% (95% UI 2·3–3·1). Despite mostly stagnant age-standardised rates, the absolute number of YLDs from non-communicable diseases has been growing rapidly across all SDI quintiles, partly because of population growth, but also the ageing of populations. The largest absolute increases in total numbers of YLDs globally were between the ages of 40 and 69 years. Age-standardised YLD rates for all conditions combined were 10·4% (95% UI 9·0–11·8) higher in women than in men. Iron-deficiency anaemia, migraine, Alzheimer’s disease and other dementias, major depressive disorder, anxiety, and all musculoskeletal disorders apart from gout were the main conditions contributing to higher YLD rates in women. Men had higher age-standardised rates of substance use disorders, diabetes, cardiovascular diseases, cancers, and all injuries apart from sexual violence. Globally, we noted much less geographical variation in disability than has been documented for premature mortality. In 2016, there was a less than two times difference in age-standardised YLD rates for all causes between the location with the lowest rate (China, 9201 YLDs per 100 000, 95% UI 6862–11943) and highest rate (Yemen, 14 774 YLDs per 100 000, 11 018–19 228). Interpretation The decrease in death rates since 1990 for most causes has not been matched by a similar decline in age-standardised YLD rates. For many large causes, YLD rates have either been stagnant or have increased for some causes, such as diabetes. As populations are ageing, and the prevalence of disabling disease generally increases steeply with age, health systems will face increasing demand for services that are generally costlier than the interventions that have led to declines in mortality in childhood or for the major causes of mortality in adults. Up-to-date information about the trends of disease and how this varies between countries is essential to plan for an adequate health-system response.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2019

Publication date (Electronic): 27 March 2019

Volume: 9

Issue: 3

Electronic Location Identifier: e026874

Affiliations

[1 ] departmentDepartment of Physiotherapy , Kathmandu University School of Medical Sciences , Dhulikhel, Bagmati, Nepal

[2 ] departmentCentre for Musculoskeletal Outcomes Research, Department of Surgical Sciences , Dunedin School of Medicine, University of Otago , Dunedin, Otago, New Zealand

[3 ] departmentDepartment of Rehabilitation Medicine , University of Washington , Seattle, Washington, USA

[4 ] University of South Australia , Adelaide, South Australia, Australia

Author notes

[Correspondence to ] Saurab Sharma; saurabsharma1@ 123456gmail.com

Author information

Saurab Sharma http://orcid.org/0000-0002-9817-5372

J Haxby Abbott http://orcid.org/0000-0001-6468-7284

Article

Publisher ID: bmjopen-2018-026874

DOI: 10.1136/bmjopen-2018-026874

PMC ID: 6475174

PubMed ID: 30918037

SO-VID: e33c4f42-a046-4a72-b7a5-56a9a129611b

License:

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/.

History

Date received : 24 September 2018

Date revision received : 15 January 2019

Date accepted : 06 February 2019

Custom metadata

special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: low back pain,pain management,musculoskeletal pain,patient education,culture,low-income country

Data availability:

ScienceOpen disciplines: Medicine

Keywords: low back pain, pain management, musculoskeletal pain, patient education, culture, low-income country

Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial

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Abstract

Objectives

Design

Setting

Participants

Interventions

Primary outcome measures

Secondary outcome measures

Results

Conclusion

Trial registration number

Related collections

Network Medicine

Most cited references 58

International physical activity questionnaire: 12-country reliability and validity.

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016

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