M54.5
Conditions
Interventions
Group 1: Intervention group (shock wave treatment): Participants in this study group receive treatment with targeted, short-pressure impulses (shock waves) that are applied externally and transmitted
the treatment is administered using an approved medical device by appropriately qualified healthcare professionals in accordance with the study protocol, with a total of four treatment sessions being
within the study, standardized assessments are conducted at predefined time points, including the evaluation of pain intensity using a validated pain scale as well as the assessment of functional limi
additionally, any adverse events are documented
the observation period extends from the start of treatment to the defined follow-up time point, which is 12 weeks after the last treatment session.
Group 2: Control group (physiotherapy): Participants
the treatment is administered by appropriately qualified healthcare professionals, and a total of six treatment sessions are performed
the observation period extends from the start of treatment until the defined follow-up time point, which is 12 weeks after the last treatment session.
Sponsors
MTS Medical AG
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diagnosis of chronic nonspecific low back pain (duration > 3 months). Patient has at least one myofascial trigger point in the lower back. Pain stage 1–3 according to Gerbershagen. Patient has not received any therapy in the past 3 months, except for analgesics (use of analgesics will be documented throughout the study). Patient is between 18 and 70 years of age at the time of informed consent. Patient has a body mass index (BMI) = 40. Patient has been adequately informed about the risks and requirements of the study and has provided written informed consent. Patient is not under arrest (as defined by MPDG §27). Patient has no documented history of alcohol or drug abuse. Female patients are not pregnant. Patient is not an employee of the investigator or Investigation Site, is not directly involved in this study or other studies conducted by the investigator or Investigation Site and is not a family member of the investigator. No neurological deficits, particularly no reflex or sensorimotor disturbances, paresis, or bladder/bowel dysfunction. No primary or secondary spinal lesions of neoplastic origin (tumour). No vascular etiology (e.g., abdominal aortic aneurysms). No unhealed fractures in the treatment area. No rheumatologic diseases in active flare. No osteoporosis without adequate therapy. No severe scoliosis (Cobb angle = 40°). No relevant skin disorders in the treatment area. No prior surgeries in the treatment area. No relevant psychological or psychiatric comorbidities. No active infections in the treatment area—including clinically or radiologically confirmed spondylodiscitis No surgical procedures performed within the last 3 months involving n the anatomical region targeted for treatment (i.e., the lower back) No surgical procedures performed within the last 3 months involving the lower trunk or proximal segments of the lower extremities Patient has no blood clotting disorders and is not taking anticoagulants. Patient does not have a pacemaker or an implanted defibrillator.
Exclusion criteria
Exclusion criteria: Patient is unwilling or unable to comply with the requirements of the study. Patient initially met all inclusion criteria but, prior to the start of therapy, developed changes affecting at least one inclusion criterion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the change in health-related quality of life, functional impairment in daily activities, and depressive symptoms or psychological distress between baseline and predefined follow-up time points. Assessments are performed at baseline, during treatment (mid-treatment), at the end of the treatment series, and at the 6- and 12-week follow-up visits. In addition, the temporal course of pain reduction is evaluated based on repeated pain intensity assessments at predefined time points during treatment and follow-up. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in pain intensity between baseline and the predefined follow-up time point, 12 weeks after the last treatment, measured using a validated pain scale. | — |
Countries
Germany
Contacts
Public ContactMartin Schulze
Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
Outcome results
None listed