RENaBack: low back pain patients in rehabilitation—study protocol for a multicenter, randomized controlled trial

Abstract Background Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country. Methods The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG). Discussion An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers. Trial registration DRKS, DRKS00020373. Registered on 15 April 2020

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Multicenter Randomized Controlled Trial to Evaluate the Effect of Home-Based Exercise on Patients With Chronic Low Back Pain

Spine ◽

10.1097/brs.0b013e3181d7a4d2 ◽

2010 ◽

Vol 35 (17) ◽

pp. E811-E819 ◽

Cited By ~ 42

Author(s):

Osamu Shirado ◽

Tokuhide Doi ◽

Masami Akai ◽

Yuichi Hoshino ◽

Keiji Fujino ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Controlled Trial ◽

Low Back ◽

Randomized Controlled ◽

Home Based ◽

Multicenter Randomized Controlled Trial

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Subcutaneous Stimulation as ADD-ON Therapy to Spinal Cord Stimulation Is Effective in Treating Low Back Pain in Patients With Failed Back Surgery Syndrome: A Multicenter Randomized Controlled Trial

Neuromodulation Technology at the Neural Interface ◽

10.1111/ner.12385 ◽

2016 ◽

Vol 19 (2) ◽

pp. 171-178 ◽

Cited By ~ 14

Author(s):

Eric-Jan J.A.A. van Gorp ◽

Onno P.M. Teernstra ◽

Ismail Gültuna ◽

Tanja Hamm-Faber ◽

Katja Bürger ◽

...

Keyword(s):

Spinal Cord ◽

Randomized Controlled Trial ◽

Low Back Pain ◽

Controlled Trial ◽

Failed Back Surgery Syndrome ◽

Low Back ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Failed Back Surgery ◽

Back Surgery

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Randomized controlled trial of behavioral skills-based virtual reality (VR) for chronic low back pain: Study protocol for self-administered at-home VR therapy (Preprint)

10.2196/preprints.25291 ◽

2020 ◽

Author(s):

Laura Garcia ◽

Beth Darnall ◽

Parthasarathy Krishnamurthy ◽

Ian Mackey ◽

Josh Sackman ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Virtual Reality ◽

Low Back Pain ◽

Back Pain ◽

Pain Management ◽

Controlled Trial ◽

Low Back ◽

Behavioral Skills ◽

Randomized Controlled

BACKGROUND Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a non-pharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS We will randomize 180 individuals with cLBP to one of two VR programs: (1) EaseVRx (eight-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a virtual reality headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2-D neutral content in a 3-D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months post-treatment using an approach suitable for the longitudinal nature of the data. RESULTS The study was approved by IRB on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020 and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches. CLINICALTRIAL ClinicalTrials.gov, NCT04415177. https://clinicaltrials.gov/ct2/show/NCT04415177

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Immediate effects of motion style acupuncture treatment (MSAT) in acute low back pain with severe disability: a multicenter, randomized, controlled trial

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2012.02.455 ◽

2012 ◽

Vol 20 ◽

pp. S269

Author(s):

T.-G. Lee ◽

J.-S. Shin ◽

I.-H. Ha ◽

Y. Choi ◽

B.-Y. Park ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Low Back ◽

Acute Low Back Pain ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Motion Style

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Rumination-Focused Cognitive-Behavioral Therapy for Chronic Low Back Pain: A Randomized Controlled Trial

Galen Medical Journal ◽

10.31661/gmj.v9i0.1722 ◽

2020 ◽

Vol 9 ◽

Author(s):

Ali Soleymani ◽

Abbas Masjedi Arani ◽

Seyed Ahmad Raeissadat ◽

Mohammad Hassan Davazdahemami

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Pain Catastrophizing ◽

Behavioral Therapy ◽

Controlled Trial ◽

Low Back ◽

Randomized Controlled

Background: Chronic pain remains or reappears for more than 3 to 6 months, and it is influencing 20% of the global population. The pain catastrophizing affects pain intensity and psychological conditions of patients with chronic pain. Rumination-focused cognitive-behavioral therapy (RFCBT) targets rumination as the key component of pain catastrophizing. The aim of this study was to determine the effectiveness of RFCBT on depression, anxiety, and pain severity of individuals with chronic low back pain (LBP). Materials and Methods: In a randomized controlled trial, 30 patients aged between 20-55 years with diagnosed chronic LBP were chosen by convenience sampling and randomly allocated into intervention and control groups. All patients used their prescribed medications for pain management, but the intervention group received 12 weekly sessions of RFCBT, which was manualized psychotherapy to change unconstructive rumination to constructive rumination. Depression Anxiety and Stress scale-21 and chronic pain grade questionnaire were administered as pre-tests and re-administered after 3 and 6 months as post-test and follow-up assessments, respectively. Results: RFCBT significantly reduced depression (F1=23.01, P=0.001), anxiety (F1=25.7, P=0.001) and pain severity (F1=7.17, P=0.012) in patients with chronic LBP. Conclusion: RFCBT may offer benefits for treating patients with chronic low back pain when added to their usual pharmacological treatment. This benefit may be the result of targeting rumination as the key element of pain catastrophizing. [GMJ.2020;9:e1722]

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Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with nonspecific low back pain [ISRCTN19334317]

BMC Musculoskeletal Disorders ◽

10.1186/1471-2474-5-40 ◽

2004 ◽

Vol 5 (1) ◽

Cited By ~ 9

Author(s):

Pieter H Helmhout ◽

Chris C Harts ◽

J Bart Staal ◽

Rob A de Bie

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Back Pain ◽

Controlled Trial ◽

Low Back ◽

Minimal Intervention ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Army Personnel

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Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-020-03829-7 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Claudia Côté-Picard ◽

Jean Tittley ◽

Catherine Mailloux ◽

Kadija Perreault ◽

Catherine Mercier ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Low Back Pain ◽

Controlled Trial ◽

Thermal Therapy ◽

Low Back ◽

Long Term Effects ◽

Randomized Controlled ◽

Secondary Outcomes

Abstract Background Low back pain (LBP) is the first cause of years lived with disability worldwide. This is due to the development of chronic pain. Thus, it is necessary to identify the best therapeutic approaches in the acute phase of LBP to limit the transition to chronic pain. Superficial heat presents the highest level of evidence for short-term reduction in pain and disability in acute LBP. Physical activity is also recommended to avoid transition to chronic LBP, but there is a lack of evidence to determine its effect to reduce acute LBP. Also, the long-term effects of these interventions are unknown. This is a protocol for a randomized controlled trial (RCT) to determine the short and long-term effects of wearable continuous low-level thermal therapy, in combination with exercises or not, on disability and pain. Methods/design Sixty-nine participants with acute LBP will be randomly assigned to one of three intervention programs: 1) thermal therapy, 2) thermal therapy + exercises, and 3) control. The interventions will be applied for 7 continuous days. The primary outcome will be disability and secondary outcomes will be pain intensity, pain-related fear, self-efficacy, number of steps walked and perception of change. The evaluators will be blinded to the interventions, and participants will be blinded to other groups’ interventions. Primary and secondary outcomes will be compared between intervention groups. Discussion This study will provide new evidence about acute LBP treatments, to limit transition to chronicity. This will be the first study to measure the long-term effects of wearable continuous low-level thermal therapy, combined or not to exercises. Trial registration This RCT has been retrospectively registered on ClinicalTrials.gov (NCT03986047) on June 14th, 2019.

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