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

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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Effects of functional taping compared with sham taping and minimal intervention on pain intensity and static postural control for patients with non-specific chronic low back pain: a randomised clinical trial protocol

Physiotherapy ◽

10.1016/j.physio.2016.05.008 ◽

2017 ◽

Vol 103 (2) ◽

pp. 154-159 ◽

Cited By ~ 3

Author(s):

F.J. Jassi ◽

T. Del Antônio ◽

R. Moraes ◽

S.Z. George ◽

T.C. Chaves

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Postural Control ◽

Pain Intensity ◽

Chronic Low Back Pain ◽

Randomised Clinical Trial ◽

Trial Protocol ◽

Low Back ◽

Minimal Intervention

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

BMJ Open ◽

10.1136/bmjopen-2018-022423 ◽

2018 ◽

Vol 8 (8) ◽

pp. e022423 ◽

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 ◽

Randomised Clinical Trial ◽

Random Allocation ◽

Low Back ◽

Willingness To Participate ◽

Physiotherapy Treatment ◽

Pain Education ◽

Registration Number

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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Factors associating with disability of non-specific low back pain in different subgroups: A hierarchical linear regression analysis

Scientific Reports ◽

10.1038/s41598-021-97569-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Takahiro Miki ◽

Daisuke Higuchi ◽

Tsuneo Takebayashi ◽

Mina Samukawa

Keyword(s):

Regression Analysis ◽

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Psychosocial Factors ◽

Self Efficacy ◽

Explanatory Power ◽

Low Back ◽

Acute Group ◽

Pain Catastrophising

AbstractThis study aimed to explore factors associating with disability, which means physical impairment affecting a person’s mobility, capacity, stamina, or agility, of non-specific low back pain (NSLBP) of the acute and non-acute groups. Two hundred thirty-five patients with NSLBP of less than 8 weeks’ duration as acute groups (n = 124) and more than 8 weeks’ duration as non-acute group (n = 111) were recruited. It was collected data on pain intensity, disability and psychosocial factors, including pain catastrophising, fear of movement and pain self-efficacy. Disability was measured Roland Morris Disability Questionnaire. A hierarchical multiple regression analysis was performed to analyse factors associating with disability of the acute and non-acute groups. The Result was that explanatory power increased with each additional variable of the order of demographic characteristics, pain intensity and psychosocial factors for both groups. Pain intensity, pain catastrophising and pain self-efficacy had significant explanatory power, with pain self-efficacy having the most significant association on the acute group. Only pain self-efficacy having the most significant association on disability of the non-acute group. In conclusion, the factors associating with disability differed depending on the duration of the disease, and pain self-efficacy might be one of the factors associating with disability of patients with NSLBP.

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A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol

BMC Musculoskeletal Disorders ◽

10.1186/1471-2474-9-58 ◽

2008 ◽

Vol 9 (1) ◽

Cited By ~ 86

Author(s):

Elaine M Hay ◽

Kate M Dunn ◽

Jonathan C Hill ◽

Martyn Lewis ◽

Elizabeth E Mason ◽

...

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Study Protocol ◽

Randomised Clinical Trial ◽

Targeted Treatment ◽

Low Back

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A Randomized Clinical Trial of Auricular Point Acupressure for Chronic Low Back Pain: A Feasibility Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/196978 ◽

2013 ◽

Vol 2013 ◽

pp. 1-9 ◽

Cited By ~ 12

Author(s):

Chao Hsing Yeh ◽

Lung Chang Chien ◽

Devora Balaban ◽

Rebecca Sponberg ◽

Jaclyn Primavera ◽

...

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Randomized Clinical Trial ◽

Feasibility Study ◽

Chronic Low Back Pain ◽

Low Back ◽

Duration Of Treatment ◽

Auricular Point

Objectives. This prospective, randomized clinical trial (RCT) was designed to investigate the feasibility and effects of a 4-week auricular point acupressure (APA) for chronic low back pain (CLBP).Methods. Participants were randomized to either true APA (true acupoints with taped seeds on the designated ear points for CLBP) or sham APA (sham acupoints with taped seeds but on different locations than those designated for CLBP). The duration of treatment was four weeks. Participants were assessed before treatment, weekly during treatment, and 1 month following treatment.Results. Participants in the true APA group who completed the 4-week APA treatment had a 70% reduction in worst pain intensity, a 75% reduction in overall pain intensity, and a 42% improvement in disability due to back pain from baseline assessment. The reductions of worst pain and overall pain intensity in the true APA group were statistically greater than participants in the sham group(P<0.01)at the completion of a 4-week APA and 1 month followup.Discussion. The preliminary findings of this feasibility study showed a reduction in pain intensity and improvement in physical function suggesting that APA may be a promising treatment for patients with CLBP.

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