McKenzie Method of Mechanical Diagnosis and Therapy was slightly more effective than placebo for pain, but not for disability, in patients with chronic non-specific low back pain: a randomised placebo controlled trial with short and longer term follow-up

2017 ◽  
Vol 52 (9) ◽  
pp. 594-600 ◽  
Author(s):  
Alessandra Narciso Garcia ◽  
Lucíola da Cunha Menezes Costa ◽  
Mark J Hancock ◽  
Fabrício Soares de Souza ◽  
Geórgia Vieira Freschi de Oliveira Gomes ◽  
...  

BackgroundThe McKenzie Method of Mechanical Diagnosis and Therapy (MDT) is one of the exercise approaches recommended by low back pain (LBP) guidelines. We investigated the efficacy of MDT compared with placebo in patients with chronic LBP.MethodsThis was a prospectively registered, two-arm randomised placebo controlled trial, with a blinded assessor. A total of 148 patients seeking care for chronic LBP were randomly allocated to either MDT (n=74) or placebo (n=74). Patients from both groups received 10 treatment sessions over 5 weeks. Patients from both groups also received an educational booklet. Clinical outcomes were obtained at the end of treatment (5 weeks) and 3, 6 and 12 months after randomisation. Primary outcomes were pain intensity and disability at the end of treatment (5 weeks). We also conducted a subgroup analysis to identify potential treatment effect modifiers that could predict a better response to MDT treatment.ResultsThe MDT group had greater improvements in pain intensity at the end of treatment (mean difference (MD) −1.00, 95% CI −2.09 to −0.01) but not for disability (MD −0.84, 95% CI −2.62 to 0.93). We did not detect between-group differences for any secondary outcomes, nor were any treatment effect modifiers identified. Patients did not report any adverse events.ConclusionWe found a small and likely not clinically relevant difference in pain intensity favouring the MDT method immediately at the end of 5 weeks of treatment but not for disability. No other difference was found for any of the primary or secondary outcomes at any follow-up times.Trial registration numberClinicalTrials.gov (NCT02123394)

2015 ◽  
Vol 95 (2) ◽  
pp. 267-273 ◽  
Author(s):  
Alessandra Narciso Garcia ◽  
Lucíola da Cunha Menezes Costa ◽  
Mark J. Hancock ◽  
Matheus Oliveira de Almeida ◽  
Fabrício Soares de Souza ◽  
...  

Background The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain. Objective The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain. Design An assessor-blinded, 2-arm, randomized placebo-controlled trial will be conducted. Setting This study will be conducted in physical therapy clinics in São Paulo, Brazil. Participants The participants will be 148 patients seeking care for chronic nonspecific low back pain. Intervention Participants will be randomly allocated to 1 of 2 treatment groups: (1) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks). Measurements The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor. Limitations Therapists will not be blinded. Conclusions This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. The results of this study will contribute to better management of this population.


2020 ◽  
pp. 026921552096385
Author(s):  
Anne Mette Schmidt ◽  
Trine Bay Laurberg ◽  
Line Thorndal Moll ◽  
Berit Schiøttz-Christensen ◽  
Thomas Maribo

Objective: To compare the long-term effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme, in terms of back-specific disability, in patients with chronic low back pain. Design: A single-centre, pragmatic, two-arm parallel, randomised controlled trial. Setting: A rheumatology rehabilitation centre in Denmark. Subjects: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. Interventions: An integrated programme (a pre-admission day, two weeks at home, two weeks inpatient followed by home-based activities, plus two 2-day inpatient booster sessions, and six-month follow-up visit) was compared with an existing programme (four-week inpatient, and six-month follow-up visit). Main measure: The primary outcome was disability measured using the Oswestry Disability Index after one year. Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). Analysis was by intention-to-treat, using linear mixed models. Results: 303 patients were assessed for eligibility of whom 165 patients (mean age 50 years (SD 13) with a mean Oswestry Disability Index score of 42 (SD 11)) were randomly allocated (1:1 ratio) to the integrated programme ( n = 82) or the existing programme ( n = 83). The mean difference (integrated programme minus existing programme) in disability was –0.53 (95% CI –4.08 to 3.02); p = 0.770). No statistically significant differences were found in the secondary outcomes. Conclusion: The integrated programme was not more effective in reducing long-term disability in patients with chronic low back pain than the existing programme.


2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Allan Riis ◽  
Michael Skovdal Rathleff ◽  
Jan Hartvigsen ◽  
Janus Laust Thomsen ◽  
Tamana Afzali ◽  
...  

Abstract Objective In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. Results We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.


2020 ◽  
Vol 34 (3) ◽  
pp. 382-393 ◽  
Author(s):  
Anne Mette Schmidt ◽  
Berit Schiøttz-Christensen ◽  
Nadine E Foster ◽  
Trine Bay Laurberg ◽  
Thomas Maribo

Objective: To compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain. Design: A single-centre, pragmatic, two-arm parallel, randomized controlled trial (1:1 ratio). Setting: A rheumatology inpatient rehabilitation centre in Denmark. Subjects: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. Interventions: An integrated rehabilitation programme comprising an alternation of three weeks of inpatient stay and 12 weeks of home-based activities was compared with an existing rehabilitation programme of four weeks of inpatient stay. Main measures: Patient-reported outcomes were collected at baseline and at the 26-week follow-up. The primary outcome was back-specific disability (Oswestry Disability Index). Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). A complete case analysis was performed. Results: A total of 303 patients were assessed for eligibility of whom 165 (mean age: 50 years (SD 13) and mean Oswestry Disability Index score 42 (SD 11)) were randomized (83 to existing rehabilitation programme and 82 to integrated rehabilitation programme). Overall, 139 patients provided the 26-week follow-up data. Baseline demographic and clinical characteristics were comparable between programmes. The between-group difference in the Oswestry Disability Index score when adjusting for the corresponding baseline score was −0.28 (95% confidence interval (CI): −4.02, 3.45) which was neither statistically nor clinically significant. No significant differences were found in the secondary outcomes. Conclusion: An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.


2013 ◽  
Vol 93 (6) ◽  
pp. 748-756 ◽  
Author(s):  
Ronaldo Fernando de Oliveira ◽  
Richard Eloin Liebano ◽  
Lucíola da Cunha Menezes Costa ◽  
Lívia Leticia Rissato ◽  
Leonardo Oliveira Pena Costa

Background Manual therapists typically advocate the need for a detailed clinical examination to decide which vertebral level should be manipulated in patients with low back pain. However, it is unclear whether spinal manipulation needs to be specific to a vertebral level. Objective The purpose of this study was to analyze the immediate effects of a single, region-specific spinal manipulation defined during the clinical examination versus a single non–region-specific spinal manipulation (applied on an upper thoracic vertebra) in patients with chronic nonspecific low back pain for the outcome measures of pain intensity and pressure pain threshold at the time of the assessment. Design This was a 2-arm, prospectively registered, randomized controlled trial with a blinded assessor. Setting The study was conducted in an outpatient physical therapy clinic in Brazil. Patients The study participants were 148 patients with chronic nonspecific low back pain (with pain duration of at least 12 weeks). Randomization The randomization schedule was generated by an independent statistician and was concealed by using consecutively numbered, sealed, opaque envelopes. Interventions A single high-velocity manipulation was administered to the upper thoracic region of the participants allocated to the non–region-specific manipulation group and to the painful lumbar levels of the participants allocated to the region-specific manipulation group. Measurements Pain intensity was measured by a 0 to 10 numeric pain rating scale. Pressure pain threshold was measured using a pressure algometer. Limitations It was not possible to blind the therapist and participants. Results A total of 148 patients participated in the study (74 in each group). There was no loss to follow-up. Both groups improved in terms of immediate decrease of pain intensity; however, no between-group differences were observed. The between-group difference for pain intensity and pressure pain threshold were 0.50 points (95% confidence interval=−0.10 to 1.10) and −1.78 points (95% confidence interval=−6.40 to 2.82), respectively. No adverse reactions were observed. Conclusion The immediate changes in pain intensity and pressure pain threshold after a single high-velocity manipulation do not differ by region-specific versus non–region-specific manipulation techniques in patients with chronic low back pain.


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