Active behavioural physiotherapy intervention for acute non-specific neck pain: a cluster randomised double-blind pilot and feasibility clinical trial.

PURPOSE: To evaluate the feasibility of an active behavioural physiotherapy intervention (ABPI) and procedures to prevent the transition to chronicity in patients with acute non-specific neck pain (ANSNP). MATERIALS AND METHODS: A cluster-randomised double-blind (assessors and participants), parallel 2-arm (ABPI versus standard physiotherapy intervention [SPI]) pilot and feasibility clinical trial was conducted owing to a pre-specified published protocol. Six public hospitals were recruited and cluster-randomised (computer-generated randomisation with block sampling). Sixty participants (30 in each arm, 10 per hospital) were assessed at baseline and 3 months following baseline for neck disability index, numerical pain rating scale, cervical range-of-motion, fear-avoidance beliefs questionnaire and EuroQol 5-dimension 5-level. RESULTS: All procedures worked well. The participants' median age was 36.5 (range 21-59, interquartile range: 20.75) years. Participants in the ABPI demonstrated better improvement in all outcomes compared to SPI. Furthermore, the number of fully recovered participants following ABPI (27/30, 90.00%) was higher than SPI (16/30, 53.33%) with fewer treatment sessions and lower costs of management. CONCLUSIONS: The findings suggest that the ABPI is feasible and valuable (e.g. a high number of fully recovered participants, fewer treatment sessions and reduced management costs compared to the SPI) in conducting a future definitive trial to evaluate the effectiveness of the ANSNP management. TRIAL REGISTRATION: TCTR20180607001Implications for RehabilitationAn active behavioural physiotherapy intervention (ABPI) is feasible to manage acute non-specific neck pain.The ABPI demonstrated a high number of fully recovered participants, fewer treatment sessions and reduced management costs compared to the standard physiotherapy intervention.The ABPI is valuable to conduct a future definitive trial to evaluate the effectiveness of acute non-specific neck pain management.

Adaptation and psychometric evaluation of the Thai version of the modified STarT Back Screening Tool in individuals with neck pain.

BACKGROUND: The modified STarT Back Screening Tool (mSBST) can be used to classify individuals with neck pain (NP) into low, medium, and high risk for chronicity. However, the mSBST-Thai version (mSBST-TH) for NP does not exist. OBJECTIVES: The aims of this study were to adapt the SBST-TH into the mSBST-TH and evaluate its psychometric properties. METHODS: The adaptation process committee included one researcher, one musculoskeletal physical therapist, and one Thai linguistic expert. A total of 261 participants (aged 20-70 years) with NP in Phitsanulok Province were invited to complete the mSBST-TH, visual analogue scale, neck disability index, fear-avoidance beliefs questionnaire (FABQ), pain catastrophizing scale, EuroQol five-dimensions five-levels questionnaire (EQ5D-5L), and EQ5D-5L-visual analogue scale (EQ5D-5L-VAS). Fifty participants completed the mSBST-TH twice, with an interval of 48 hours to perform test-retest reliability. RESULTS: The Cronbach's alpha coefficient of the mSBST-TH total score was 0.73. Factor analysis revealed two components, psychosocial and physical. The intraclass correlation coefficient of test-retest reliability was found to be 0.81 for the total score. Moderate correlations were found between the mSBST-TH and all questionnaires, except for the FABQ-work. The discriminative validity was excellent between the mSBST-TH total score and the EQ5D-5L-VAS. The standard error of measurement and minimal detectable change of the mSBST-TH total score were 0.56 and 1.56, respectively. No significant floor and ceiling effects were found. CONCLUSION: The mSBST-TH was successfully adapted with no ambiguity reported. Furthermore, the mSBST-TH has presented acceptable psychometric evaluation.

Central Sensitisation Inventory-Thai version: translation, cross-cultural adaptation, and psychometric evaluation in chronic non-specific neck pain.

PURPOSE: To translate and cross-culturally adapt the English version of the Central Sensitisation Inventory (CSI) into Thai (CSI-Thai) and to evaluate its psychometric properties in individuals with chronic non-specific neck pain. MATERIALS AND METHODS: Cross-cultural translation and adaptation of the CSI were performed according to standard guidelines. A total of 340 participants were invited to complete the CSI-Thai, Visual Analogue Scale (pain intensity), Neck Disability Index, Fear-Avoidance Beliefs Questionnaire, Pain Catastrophising Scale (PCS), and Short Form-36. Psychometric evaluation included confirmatory factor analysis, internal consistency, test-retest reliability, agreement, and construct validity. RESULTS: Dimensionality analyses indicated that a bifactor model, comprising one general factor plus four orthogonal factors, fit the CSI structure better than unidimensional and the four-factor models. The general factor showed substantial reliability (Cronbach α = 0.91, Omega ω = 0.94, and omega hierarchical ω-h = 0.91). The intraclass correlation coefficient was 0.90, representing excellent stability over a 48 h interval. Moderate-to-strong correlations and acceptable-to-excellent discriminations were found between the CSI-Thai and all questionnaires. The exception was the PCS (no correlation and discrimination). The standard error of measurement and minimal detectable change of the CSI-Thai were 2.33 and 6.47, respectively. CONCLUSIONS: The translation and cross-cultural adaptation of the CSI-Thai were successful, with satisfactory reliability and construct validity.Implications for rehabilitationCentral Sensitisation Inventory-Thai version (CSI-Thai) is successfully adapted and demonstrated satisfactory reliability and construct validity.The CSI-Thai can be applicable to assess central sensitisation-related signs and symptoms in Thai-speaking patients with chronic non-specific neck pain (CNSNP) both clinical and research purposes.The CSI-Thai correlated to pain, disability and quality of life among patients with CNSNP.

Effectiveness of interventions for middle-aged and ageing population with neck pain: a systematic review and network meta-analysis protocol.

INTRODUCTION: Neck pain (NP) is a common musculoskeletal complaint and is increasing in prevalence. Current clinical practice guidelines and systematic reviews recommended conservative, pharmacological and invasive interventions for individuals with NP. However, optimal management specifically for those who are middle-aged or older adults (≥45 years) is not available; and important considering our ageing population. METHODS AND ANALYSIS: A systematic review with network meta-analysis (NMA) will be conducted following the Cochrane guidelines. Eligibility criteria include randomised controlled/clinical trials evaluating any of acute (<3 months) or chronic (≥3 months) non-specific NP, whiplash associated disorders, cervical radiculopathy and cervicogenic headache. Any interventions and outcome measures detailed within The International Classification of Functioning, Disability and Health domains will be included. Two independent reviewers will search key databases (AMED, CENTRAL, CINAHL, Embase, MEDLINE, PEDro and PsycINFO), grey literature, key journals and reference lists in May 2022. Two reviewers will decide eligibility and assess risk of bias (ROB) of included studies. The kappa statistic will be used to evaluate agreement between the reviewers at each stage. Data will be extracted by one reviewer and checked for accuracy by a second reviewer. Descriptive data and ROB will be summarised and tabulated. Traditional pairwise meta-analysis using random-effect model will be performed for all direct comparisons, and NMA using a frequentist random-effect model then performed based on NP classification where possible. A network of traditional pairwise meta-analysis allows comparisons of multiple interventions from both direct and indirect evidence to provide a hierarchal establishment for enhancing decision making of clinical practitioners. ETHICS AND DISSEMINATION: Ethic approval is not required as the study is a literature review. The findings will be shared with the national and international researchers, healthcare professionals and the general public through publishing in a peer-reviewed journal and presentations at conferences. PROSPERO REGISTRATION NUMBER: CRD42021284618.

Translation, cross-cultural adaptation and psychometric evaluation of the Thai version of the fear-avoidance beliefs questionnaire in patients with non-specific neck pain.

OBJECTIVES: Fear-avoidance beliefs questionnaire (FABQ) is a self-report, valid and reliable questionnaire to quantify fear and avoidance beliefs related to physical activity and work. Furthermore, it can be used to predict prolong disability in patients with non-specific neck pain. Although it was originally developed to manage patients with low back pain, it has also been studied in individuals with neck pain. This questionnaire was translated into several languages following reports of potential benefits in patients with neck pain. Recently, Thai neck clinical trials, international multi-centre trials and data sharing are growing throughout the world but no validated Thai version of the FABQ is available for clinical and research uses. Our objectives were to translate and cross-culturally adapt the FABQ into Thai version and evaluate its psychometric properties in Thai patients with non-specific neck pain. METHODS: Cross-cultural translation and adaptation of the FABQ were conducted according to standard guidelines. A total of 129 participants with non-specific neck pain were invited to complete the Thai versions of the FABQ (FABQ-TH), neck disability index and visual analogue scale for pain intensity. Psychometric evaluation included exploratory factor analysis, internal consistency, test-retest reliability, agreement, and convergent validity. Thirty participants completed the FABQ-TH twice with a 48-h interval between tests to assess the test-retest reliability. RESULTS: Factor analysis identified four components for the FABQ-TH (66.69% of the total variance). The intraclass correlation coefficient of test-retest reliability was excellent for the total score (0.986), work attitudes (0.995), physical activity attitudes (0.958), physical activity experiences (0.927), and expected recovery (0.984). Cronbach's alpha for internal consistency was excellent (range 0.87-0.88) for all items. The minimal detectable change of the FABQ-TH was 5.85. The FABQ-TH correlated to its subscales (range 0.470-0.936), indicating the strongest association with work attitude. The weakest correlation was observed between the FABQ-TH and disability (rs =0.206, p=0.01). Missing data and significant floor or ceiling effects were not found. CONCLUSIONS: The Thai version of the FABQ for non-specific neck pain was successfully adapted. It is a valid and reliable instrument to quantify fear and avoidance beliefs among patients with non-specific neck pain who speak and read Thai.

Translation, cross-cultural adaptation and psychometric validation of the Thai version of the STarT Back Screening Tool in patients with non-specific low back pain.

BACKGROUND: Low back pain (LBP) is a top musculoskeletal problem and a substantial cause of socioeconomic burden internationally. The STarT Back Screening Tool (SBST) is a useful screening tool to manage patients with LBP but it is unavailable in Thai. Therefore, the aims of this study were to translate and cross-culturally adapt the SBST into a Thai version (SBST-TH) and validate its psychometric properties (e.g., factor analysis, internal consistency, test-retest reliability, agreement, convergent validity and discriminative validity). METHODS: Translation and cross-cultural adaptation of the SBST into Thai version were conducted according to standard guidelines. A total of 200 participants with non-specific LBP were invited to complete the SBST, visual analogue scale for pain intensity, Roland-Morris disability questionnaire (RMDQ), fear-avoidance beliefs questionnaire, pain catastrophising scale, hospital anxiety and depression scale and the EuroQol five-dimensional questionnaire. Thirty participants completed the SBST-TH twice with an interval of 48 h to evaluate test-retest reliability. RESULTS: Factor analysis demonstrated two (physical and psychological) components for the SBST-TH (39.38% of the total variance). The Cronbach's alpha (0.86 for total score and 0.76 for psychosocial subscore) represent satisfactory internal consistency. The acceptability of intraclass correlation coefficient was found in the total (0.73) and subscore (0.79). The areas under the curve (AUC) for the total score ranged 0.67-0.85 and 0.66-0.75 for subscore. The excellent discriminative validity was observed (AUC = 0.85, 95% confidence interval = 0.72, 0.97) between the total score of the SBST-TH and disability (RMDQ). Spearman's correlation coefficients represented moderate to strong correlation (0.32-0.56) between the SBST-TH and all questionnaires. The findings suggest a good relationship between the SBST-TH and disability and quality of life. Owing to the results from the convergent and discriminative validity, construct validity of the SBST-TH can be supported. The minimal detectable changes of the total score and subscore were 2.04 and 1.60, respectively. Significant floor and ceiling effects were not found in the SBST-TH. CONCLUSION: The SBST-TH was successfully translated and adapted. It is a valid and reliable tool to classify Thai patients with non-specific LBP into low, moderate and high risks for chronicity. TRIAL REGISTRATION: TCTR20191009005 #.

Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol.

INTRODUCTION: Non-specific neck pain causes pain and disability and contributes substantial socioeconomic burden internationally. Up to 50% of adults experience neck pain annually, leading to reduced the quality of life. An active behavioural physiotherapy intervention (ABPI) may be feasible to manage patients with acute non-specific neck pain to prevent transition to chronicity. A recent pilot and feasibility trial investigating an acute whiplash-associated disorder population found potential value of the ABPI with 95% of participants fully recovered (Neck Disability Index: NDI ≤4, compared with 17% in the standard physiotherapy arm); supporting a definitive trial. Qualitative findings from the physiotherapists supported the potential of the ABPI in a non-specific neck pain population. METHODS AND ANALYSIS: Two phases: (1) Pragmatic cluster randomised double-blind, parallel 2-arm (ABPI vs standard physiotherapy intervention) pilot and feasibility trial to evaluate the procedures and feasibility of the ABPI for the management of acute non-specific neck pain. Six physiotherapy departments from six public hospitals in Thailand will be recruited and cluster randomised by a computer-generated randomisation sequence with block sampling. Sixty participants (30 each arm, 10 per hospital) will be assessed at baseline and 3 months following baseline for NDI, Numerical Rating Scale for pain intensity, cervical range of motion, fear-avoidance beliefs questionnaire and EuroQol-5 dimensions 5 levels outcomes, and (2) Embedded qualitative study using semistructured interviews to explore acceptability of the ABPI to participants (n=12) and physiotherapists (n=3). Descriptive analysis of the quantitative data and interpretative phenomenological analysis to code and analyse qualitative data (deductive and inductive) will inform feasibility for a future definitive trial. ETHICS AND DISSEMINATION: This trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61). TRIAL REGISTRATION NUMBER AND STATUS: TCTR20180607001; Recruiting commenced 1 February 2019.

A cluster randomised, double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute whiplash-associated disorder (WAD)II.

Whiplash-associated disorder (WAD) causes substantial social and economic burden, with ≥70% patients classified as WADII (neck complaint and musculoskeletal sign(s)). Effective management in the acute stage is required to prevent development of chronicity; an issue for 60% of patients. An Active Behavioural Physiotherapy Intervention (ABPI) was developed to address both physical and psychological components of WAD. The ABPI is a novel complex intervention designed through a rigorous sequential multiphase project to prevent transition of acute WAD to chronicity. An external pilot and feasibility cluster randomised double-blind (assessor, participants) parallel two-arm clinical trial was conducted in the UK private sector. The trial compared ABPI versus standard physiotherapy to evaluate trial procedures and feasibility of the ABPI for managing acute WADII in preparation for a future definitive trial. Six private physiotherapy clinics were recruited and cluster randomised using a computer-generated randomisation sequence. Twenty-eight (20 ABPI, 8 standard physiotherapy) participants [median age 38.00 (IQR = 21.50) years] were recruited. Data were analysed descriptively with a priori establishment of success criteria. Ninety-five percent of participants in the ABPI arm fully recovered (Neck Disability Index ≤4, compared to 17% in the standard physiotherapy arm); required fewer treatment sessions; and demonstrated greater improvement in all outcome measures (pain intensity, Cervical Range of Motion, Pressure Pain Threshold, EuroQol-5 Dimensions) except for the Impact of Events Scale and Fear Avoidance Beliefs Questionnaire. The findings support the potential value of the ABPI, and that an adequately powered definitive trial to evaluate effectiveness (clinical, cost) is feasible with minor modifications to procedures.

Development of an active behavioural physiotherapy intervention (ABPI) for acute whiplash-associated disorder (WAD) II management: a modified Delphi study.

OBJECTIVE: To develop an active behavioural physiotherapy intervention (ABPI) for managing acute whiplash-associated disorder (WAD) II using a modified Delphi method to develop consensus for the basic features of the ABPI. DESIGN: Modified Delphi study. Our systematic review and meta-analysis evaluating conservative management for acute WADII found that a combined ABPI may be a useful intervention to prevent patients progressing to chronicity. No previous research has considered a combined behavioural approach and active physiotherapy in the management of acute WADII patients. The ABPI was therefore developed using a rigorous consensus method using international research and local clinical whiplash experts. Descriptive statistics were used to assess consensus in each round. SETTING: Online international survey. PARTICIPANTS: A purposive sample of 97 potential participants (aiming to recruit n=30) consisting of international research whiplash experts, UK private physiotherapists and UK postgraduate musculoskeletal physiotherapy students were invited to participate via electronic mail with an attached participant information sheet and consent form. RESULTS: 36 individuals signed and returned the consent form. In round 1, 32/36 participants (response rate=89%, mean age±SD=36.03±13.22 years) across 8 countries (Australia, Finland, Greece, India, Netherlands, Norway, Sweden and UK) contributed to round 1 questionnaire. Response rates were 78% and 75% for rounds 2 and 3, respectively. Following round 3, 12 underlying principles (eg, return to normal function as soon as possible, pain management, encouragement of self-management, reduce fear avoidance and anxiety) achieved consensus. The treatment components reaching consensus included behavioural (eg, education, reassurance, self-management) and physiotherapy components (eg, exercises for stability and mobility). No passive intervention achieved consensus. CONCLUSIONS: Experts suggested and agreed the underlying principles and treatment components of the ABPI for the management of acute WADII. The ABPI was underpinned by social cognitive theory focusing on self-efficacy enhancement prior to conducting a phase II trial.

Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting.

INTRODUCTION: Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. METHODS AND ANALYSIS: Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3-4 physiotherapists) and a focus group (n=6-8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). ETHICS AND DISSEMINATION: This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). TRIAL REGISTRATION NUMBER: ISRCTN84528320.

The Effectiveness of Conservative Management for Acute Whiplash Associated Disorder (WAD) II: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: To evaluate the effectiveness of conservative management (except drug therapy) for acute Whiplash Associated Disorder (WAD) II. DESIGN: Systematic review and meta-analysis of Randomised Controlled Trials (RCTs) using a pre-defined protocol. Two independent reviewers searched information sources, decided eligibility of studies, and assessed risk of bias (RoB) of included trials. Data were extracted by one reviewer and checked by the other. A third reviewer mediated any disagreements throughout. Qualitative trial and RoB data were summarised descriptively. Quantitative syntheses were conducted across trials for comparable interventions, outcome measures and assessment points. Meta-analyses compared effect sizes with random effects, using STATA version 12. DATA SOURCES: PEDro, Medline, Embase, AMED, CINAHL, PsycINFO, and Cochrane Library with manual searching in key journals, reference lists, British National Bibliography for Report Literature, Center for International Rehabilitation Research Information & Exchange, and National Technical Information Service were searched from inception to 15th April 2015. Active researchers in the field were contacted to determine relevant studies. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: RCTs evaluating acute (<4 weeks) WADII, any conservative intervention, with outcome measures important to the International Classification of Function, Disability and Health. RESULTS: Fifteen RCTs all assessed as high RoB (n=1676 participants) across 9 countries were included. Meta-analyses enabled 4 intervention comparisons: conservative versus standard/control, active versus passive, behavioural versus standard/control, and early versus late. Conservative intervention was more effective for pain reduction at 6 months (95%CI: -20.14 to -3.38) and 1-3 years (-25.44 to -3.19), and improvement in cervical mobility in the horizontal plane at <3 months (0.43 to 5.60) compared with standard/control intervention. Active intervention was effective for pain alleviation at 6 months (-17.19 to -3.23) and 1-3 years (-26.39 to -10.08) compared with passive intervention. Behavioural intervention was more effective than standard/control intervention for pain reduction at 6 months (-15.37 to -1.55), and improvement in cervical movement in the coronal (0.93 to 4.38) and horizontal planes at 3-6 months (0.43 to 5.46). For early (<4 days) versus late (>10 days) interventions, there were no statistically significant differences in all outcome measures between interventions at any time. CONCLUSIONS: Conservative and active interventions may be useful for pain reduction in patients with acute WADII. Additionally, cervical horizontal mobility could be improved by conservative intervention. The employment of a behavioural intervention (e.g. act-as-usual, education and self-care including regularly exercise) could have benefits for pain reduction and improvement in cervical movement in the coronal and horizontal planes. The evidence was evaluated as low/very low level according to the Grading of Recommendations Assessment, Development and Evaluation system.