Clinical trial NCT05308641: Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain
Official title: Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Keywords: radial shockwave therapy
chronic low back pain
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Analysis of the effectiveness of radial shock wave therapy as part of a multimodal pain therapy in the inpatient setting. Different therapy protocols are compared in previously non-operated and in previously operated patients.

Detailed description: Radial shock wave therapy is an approved pain therapy procedure that has been used in various degenerative orthopedic diseases for years. There are a few studies on the subject of chronic back pain. Some studies suggest that this method can be used sensibly. A direct comparison of different therapy protocols has not been carried out so far.

As part of inpatient multimodal pain therapy (including infiltration and physiotherapy) in patients with chronic lumbar back pain with or without degenerative surgery in the area of the lumbar spine radial shock wave therapy after a specific protocol is used. Only inpatients will be admitted to the study. All patients are informed verbally and give their written consent. Comprehensive patient information will be provided before the start of the study, handed out and explained as part of the information discussion. There will be 2 groups ((a) patients with previous degenerative surgery in the area of the lumbar spine, (b) patients without such a pre-operation) examined each with 4 sub-groups depending of the different therapy protocols.

Eligibility criteria: Inclusion Criteria:

* chronic lumbar back pain of min 3 months duration

Exclusion Criteria:

* radicular pain of higher intensity than chronic low back pain (cLBP)
* new neurologic deficits
* anticoagulant therapy
* new trauma to the lumbar spine
* spine bacterial infection
* spine tumor
* pregnancy
* coagulation disorder
* previous infiltration to the lumbar spine within 6 weeks prior to study inclusion
* fibromyalgia

Primary outcomes:
measure: change in Numeric Rating Scale (NRS)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Secondary outcomes:
measure: change in Oswestry Disability Index (ODI)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in European Quality of Life 5 Dimensions (EQ5D)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in Perseverative Thinking Questionnaire (PTQ)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in Patient Specific Functional Scale (PSFS)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in The World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in Big Five Inventory-SocioOeconomicPanel (BFI-S)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
measure: change in Questionnaire Subgroups for Targeted Treatment (STarT-G)
timeFrame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Hattingen
country: Germany
facility: Klinik Blankenstein
Study officials:
affiliation: Department of Orthopaedics and Trauma Surgery, St. Josef-Hospital, Ruhr-University Bochum
name: Tobias L Schulte, Prof
role: STUDY_DIRECTOR
References:
citation: Lange T, Deventer N, Gosheger G, Lampe LP, Bockholt S, Schulze Boevingloh A, Schulte TL. Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial. J Clin Med. 2021 Nov 26;10(23):5569. doi: 10.3390/jcm10235569.