Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial)

IntroductionLow back pain (LBP) is the leading cause of years lived with disability in Nepal and elsewhere. Management of LBP that is evidence-based, easily accessible, cost-effective and culturally appropriate is desirable. The primary aim of this feasibility study is to determine if it is feasible to conduct a full randomised clinical trial evaluating the effectiveness of pain education as an intervention for individuals with LBP in Nepal, relative to guideline-based physiotherapy treatment. The findings of the study will inform the planning of a full clinical trial and if any modifications are required to the protocol before undertaking a full trial.Methods/analysisThis protocol describes an assessor-blinded feasibility clinical trial investigating feasibility of the pain education intervention in patients with non-specific LBP in a physiotherapy hospital in Kathmandu, Nepal. Forty patients with LBP will be randomly allocated to either pain education or guideline-based physiotherapy treatment (control). Outcomes will be assessed at baseline and at a 1 week post-treatment. The primary outcomes are related to feasibility, including: (1) participant willingness to participate in a randomised clinical trial, (2) feasibility of assessor blinding, (3) eligibility and recruitment rates, (4) acceptability of screening procedures and random allocation, (5) possible contamination between the groups, (6) intervention credibility, (7) intervention adherence, (8) treatment satisfaction and (9) difficulty in understanding the interventions being provided.Ethics/disseminationThe protocol was approved by Nepal Health Research Council (NHRC; registration number: 422/2017) and University of Otago Human Ethics Committee for Health (registration number: H17/157). The results of the study will be presented at national and international conferences and published in a peer-reviewed journal.Trial registration numberNCT03387228; Pre-results.

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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

BMJ Open ◽

10.1136/bmjopen-2018-026874 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026874 ◽

Cited By ~ 8

Author(s):

Saurab Sharma ◽

Mark P Jensen ◽

G Lorimer Moseley ◽

J Haxby Abbott

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Outcome Measures ◽

Randomised Clinical Trial ◽

Education Intervention ◽

Low Back ◽

Pain Education ◽

Pain Catastrophising

ObjectivesThe 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.DesignA two-arm, parallel, assessor-blinded, feasibility RCT.SettingA rehabilitation hospital in Kathmandu, Nepal.ParticipantsForty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women).InterventionsEligible 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 measuresThe 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 measuresPain 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.ResultsForty 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.ConclusionWe conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted.Trial registration numberNCT03387228; Results.

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Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone—protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain

BMJ Open ◽

10.1136/bmjopen-2021-050808 ◽

2022 ◽

Vol 12 (1) ◽

pp. e050808

Author(s):

Lisette Bijker ◽

Leonore de Wit ◽

Pim Cuijpers ◽

Eva Poolman ◽

Gwendolijne Scholten-Peeters ◽

...

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Neck Pain ◽

Randomised Clinical Trial ◽

Spinal Pain ◽

Low Back ◽

Behavioural Activation ◽

Pain Education ◽

Ehealth Intervention

IntroductionPsychosocial factors predict recovery in patients with spinal pain. Several of these factors are modifiable, such as depression and anxiety. However, primary care physiotherapists who typically manage these patients indicate that they do not feel sufficiently competent and equipped to address these factors optimally. We developed an eHealth intervention with a focus on pain education and behavioural activation to support physiotherapists in managing psychosocial factors in patients with spinal pain. This paper describes the protocol for a pragmatic randomised clinical trial, which evaluates the effectiveness of this eHealth intervention blended with physiotherapy compared with physiotherapy alone.Methods and analysisParticipants with non-specific low back pain and/or neck pain for at least 6 weeks who also have psychosocial risk factors associated with the development or maintenance of persistent pain will be recruited in a pragmatic multicentre cluster randomised clinical trial. The experimental intervention consists of physiotherapy blended with six online modules of pain education and behavioural activation. The control intervention consists of usual care physiotherapy. The primary outcomes are disability (Oswestry Disability Index for low back pain and Neck Disability Index for neck pain) and perceived effect (Global Perceived Effect). Outcomes will be assessed at baseline and at 2, 6 and 12 months after baseline. The results will be analysed using linear mixed models.Ethics and disseminationThe study is approved by the Medical Ethical Committee of VU Medical Center Amsterdam, The Netherlands (2017.286). Results will be reported in peer-reviewed journals, at national and international conferences, and in diverse media to share the findings with patients, clinicians and the public.Trial registration numberNL 5941; The Netherlands Trial Register.

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