Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial

IntroductionDoin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare.Methods and analysisThis multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-effectiveness of acupuncture with Doin therapy. A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals. Patients will be randomly allocated to acupuncture with Doin therapy (n=62) and acupuncture alone (n=62) for 5 weeks of treatment. This study will be carried out with outcome assessor and statistician blinding. The primary outcome measure will consist of improvement in neck pain using the Visual Analogue Scale at 6 weeks. The secondary outcomes including measures of pain, functional disability, health-related quality of life and economic evaluation will be conducted at 6 weeks, and 3, 6, 9 and 12 months after treatmentEthics and disseminationThe project is approved by the Institutional Review Board (IRB) of the Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong. Dissemination will occur after the findings from this study are published in other peer reviewed journals.Trial registration numbersNCT03558178; KCT0003068; Pre-results.

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“Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.”

Clinical Rehabilitation ◽

10.1177/0269215520965054 ◽

2020 ◽

pp. 026921552096505

Author(s):

Vanessa González-Rueda ◽

Carlos López-de-Celis ◽

Elena Bueno-Gracia ◽

Jacobo Rodríguez-Sanz ◽

Albert Pérez-Bellmunt ◽

...

Keyword(s):

Neck Pain ◽

Rating Scale ◽

Controlled Trial ◽

Neck Disability Index ◽

Chronic Neck Pain ◽

Control Group ◽

Controlled Clinical Trial ◽

Primary Care Center ◽

Randomized Controlled ◽

Upper Cervical

Objective: To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients. Design: Randomized controlled trial. Setting: Primary Care Center in Cornellà, Spain. Subjects: 78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups. Interventions: All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions. Main measures: Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up. Results: NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group. Conclusions: Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups. Trial registration: This study was registered in Clinicaltrials.gov (NCT02832232).

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Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial

European Spine Journal ◽

10.1007/s00586-016-4526-0 ◽

2016 ◽

Vol 25 (7) ◽

pp. 2087-2096 ◽

Cited By ~ 5

Author(s):

J. M. van Dongen ◽

R. Groeneweg ◽

S. M. Rubinstein ◽

J. E. Bosmans ◽

R. A. B. Oostendorp ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Neck Pain ◽

Manual Therapy ◽

Controlled Trial ◽

Chronic Neck Pain ◽

Randomised Controlled

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Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/1471-2474-7-99 ◽

2006 ◽

Vol 7 (1) ◽

Cited By ~ 26

Author(s):

Gemma C Salter ◽

Mark Roman ◽

Martin J Bland ◽

Hugh MacPherson

Keyword(s):

Randomised Controlled Trial ◽

Neck Pain ◽

Controlled Trial ◽

Chronic Neck Pain ◽

Randomised Controlled

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Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial

Trials ◽

10.1186/1745-6215-14-209 ◽

2013 ◽

Vol 14 (1) ◽

pp. 209 ◽

Cited By ~ 11

Author(s):

Hugh MacPherson ◽

Helen E Tilbrook ◽

Stewart J Richmond ◽

Karl Atkin ◽

Kathleen Ballard ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Neck Pain ◽

Usual Care ◽

Study Protocol ◽

Controlled Trial ◽

Chronic Neck Pain ◽

Alexander Technique ◽

Randomised Controlled

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Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽

10.1186/s13063-019-3838-x ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Aisha Shafayat ◽

Emese Csipke ◽

Lucy Bradshaw ◽

Georgina Charlesworth ◽

Florence Day ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Rating Scale ◽

Controlled Trial ◽

Randomised Trial ◽

Mild Dementia ◽

Link Type ◽

Feasibility Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

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Erratum to: Chronic neck pain and treatment of cognitive and behavioural factors: results of a randomised controlled clinical trial

European Spine Journal ◽

10.1007/s00586-012-2358-0 ◽

2012 ◽

Vol 21 (8) ◽

pp. 1567-1567

Author(s):

Marco Monticone ◽

Paola Baiardi ◽

Carla Vanti ◽

Silvano Ferrari ◽

Tiziana Nava ◽

...

Keyword(s):

Clinical Trial ◽

Neck Pain ◽

Chronic Neck Pain ◽

Controlled Clinical Trial ◽

Randomised Controlled Clinical Trial ◽

Behavioural Factors ◽

Randomised Controlled

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Cost-Effectiveness of Manual Therapy Versus Physical Therapy In Patients With Sub-Acute and Chronic Neck Pain: A Randomized Controlled Trial

Value in Health ◽

10.1016/j.jval.2015.09.2447 ◽

2015 ◽

Vol 18 (7) ◽

pp. A669-A670

Author(s):

JM van Dongen ◽

R Groeneweg ◽

SM Rubinstein ◽

JE Bosmans ◽

RA Oostendorp ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cost Effectiveness ◽

Physical Therapy ◽

Neck Pain ◽

Manual Therapy ◽

Controlled Trial ◽

Chronic Neck Pain ◽

Randomized Controlled

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Effectiveness and cost-effectiveness of a guided internet- and mobile-based depression intervention for individuals with chronic back pain: protocol of a multi-centre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-015226 ◽

2017 ◽

Vol 7 (12) ◽

pp. e015226 ◽

Cited By ~ 9

Author(s):

Jiaxi Lin ◽

Lasse Sander ◽

Sarah Paganini ◽

Sandra Schlicker ◽

David Ebert ◽

...

Keyword(s):

Back Pain ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Rating Scale ◽

Chronic Back Pain ◽

Controlled Trial ◽

Work Capacity ◽

Cost Utility ◽

Rehabilitation Care ◽

Randomised Controlled

IntroductionDepression often co-occurs with chronic back pain (CBP). Internet and mobile-based interventions (IMIs) might be a promising approach for effectively treating depression in this patient group. In the present study, we will evaluate the effectiveness and cost-effectiveness of a guided depression IMI for individuals with CBP (eSano BackCare-D) integrated into orthopaedic healthcare.Methods and analysisIn this multicentre randomised controlled trial of parallel design, the groups eSano BackCare-D versus treatment as usual will be compared. 210 participants with CBP and diagnosed depression will be recruited subsequent to orthopaedic rehabilitation care. Assessments will be conducted prior to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The primary outcome is depression severity (Hamilton Rating Scale for Depression-17). Secondary outcomes are depression remission and response, health-related quality of life, pain intensity, pain-related disability, self-efficacy and work capacity. Demographic and medical variables as well as internet affinity, intervention adherence, intervention satisfaction and negative effects will also be assessed. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. Moreover, a cost-effectiveness and cost-utility analysis will be conducted from a societal perspective after 6 months.Ethics and disseminationAll procedures are approved by the ethics committee of the Albert-Ludwigs-University of Freiburg and the data security committee of the German Pension Insurance (Deutsche Rentenversicherung). The results will be published in peer-reviewed journals and presented on international conferences.Trial registration numberDRKS00009272; Pre-results.

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