Shock wave therapy for chronic low back pain

ISRCTN	ISRCTN13785224
DOI	https://doi.org/10.1186/ISRCTN13785224
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	WPBWF1/18
Sponsor	Opole Medical School
Funder	Opole Medical School

Submission date: 20/11/2019
Registration date: 04/12/2019
Last edited: 13/06/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Chronic back pain is defined as pain that persists for 12 weeks or longer, even after an initial injury or underlying cause of acute low back pain has been treated. About 20 per cent of people affected by acute low back pain develop chronic low back pain with persistent symptoms at one year. In some cases, treatment successfully relieves chronic low back pain, but in other cases pain persists despite medical and surgical treatment. Shock wave therapy is a procedure where shock waves are passed through the skin to the affected area using a special device, and ultrasound guidance may be used.
The aim of this study is to assess the effectiveness of Radial Shock Wave Therapy (RSWT) and Focused Shock Wave Therapy (FSWT) and to compare real procedures to sham procedures in the treatment of low back pain. These two types of Extracorporeal Shock Wave Therapy were chosen because of the differences in tissues penetration. Both are increasingly used to treat patients with low back pain, but there was no reliable research that assessed which one is more effective.

Who can participate?
Patients aged 18 and over, both males and females, with chronic low back pain.

What does the study involve?
Participants are randomly allocated to receive RSWT, FSWT, sham RSWT or sham FSWT, 10 times in total. Pain relief and functional improvement are measured before and after treatment and during follow-up visits 1 and 3 months after the end of the study.

What are the possible benefits and risks of participating?
Participants will receive a complete treatment program, which may lead to reduced pain and functional improvement. Risks include temporary pain up to 24 hours after the shock wave procedure.

Where is the study run from?
Opole Medical School (Poland)

When is the study starting and how long is it expected to run for?
June 2018 to August 2020

Who is the main contact?
1. Dr Katarzyna Rajfur
k.rajfur@gmail.com
2. Prof. Jakub Taradaj
j.taradaj@awf.katowice.pl

Contact information

Dr Katarzyna Rajfur
Public

68 Katowicka Street
Opole
45-065
Poland

ORCID ID	0000-0002-0310-6869
Phone	+48 (0)506202372
Email	k.rajfur@gmail.com

Prof Jakub Taradaj
Scientific

Mikołowska 72B Street
Katowice
40-065
Poland

ORCID ID	0000-0002-1796-5832
Phone	+48 (0)668613945
Email	j.taradaj@awf.katowice.pl

Study information

Primary study design	Interventional
Study design	Prospective randomized single-blinded study with follow-up analysis
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Long and short term clinical, functional and postural outcomes of radial vs. focused extracorporeal shock wave therapy in patients with chronic low back pain
Study objectives	1. Both Radial Shock Wave Therapy (RSWT) and Focused Shock Wave Therapy (FSWT) are effective in pain relief in patients with chronic low back pain  2. The RSWT and FSWT are effective in functional improvement in individuals with chronic low back pain  3. Both RSWT and FSWT improve postural control in subjects with chronic low back pain  4. The RSWT and FSWT improve gait parameters in participants with chronic low back pain 5. According to biological and physical mechanisms, it seams the FSWT promote more effective clinical, functional and postural outcomes compared to the RSWT
Ethics approval(s)	Approved 13/08/2018, Research Ethics Committee from Opole Medical School (68 Katowicka Street; 45-065; Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/90/FI/2018
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	After baseline assessments, the participants will be randomly assigned to: 1. FESWT and core stability exercises, or 2. RESWT and core stability exercises, or 3. Sham FESWT and core stability exercises, or 4. Sham RESWT and core stability exercises The individuals receiving the treatment will be blinded. A computer-generated list of random numbers will be used and concealed from the researchers enrolling and assessing the participants. The outcome assessors and data analysts will be kept blinded to the allocation The treatment protocol will include core stability training (45 minutes, once a day, five days a week from Monday to Friday) with myofascial relaxation of the erector spinae, activation of the lumbo-pelvic-hip complex and deep muscles, stimulation of proper breathing, dynamic postural exercises, and treatment with RESWT (2 000 shots each session; energy flux density of 0.1 mJ/mm2; frequency of 5 Hz) using a pneumatic device in group A, or treatment with FESWT (1 000 shots each session; energy flux density of 0.15 mJ/mm2; frequency of 4 H) using an ultrasound device in group B. The procedures were performed twice a week (Monday and Thursday) for a period of five weeks (10 procedures in total). Participants in group C and D were treated with the same core stability training compared to previous groups and additionally with the sham physical procedures. The shock wave therapy was identical to that of group A and B (the sham stimulation was voided of biologically active components by applying a special polyethylene applicator cap, which absorbed energy and limited its propagation to the human tissues) with the same sound signals during the procedure of the pneumatic/ultrasound head and the same technical parameters as in the real procedures.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Pain assessed with the Visual-Analogue Scale and the Laitinen Pain Indicator Questionnaire at baseline, after treatment, and during follow-up visits at one and three months
Key secondary outcome measure(s)	Measured at baseline, after treatment, and during follow-up visits at one and three months: 1. Quality of life assessed with the Oswestry and Roland–Morris Disability Questionnaire 2. Posture stability with open and closed eyes measured using posturography 3. Gait analysed using medical treadmill 4. Mobility range in the hip joint on the side of the herniated disc in the course of spinal discopathy measured using the Lasèque test. The starting position is lying down on the back with both legs straight. The examiner then slowly lifts one of the patient’s legs while the knee is straight at the joint until pain occurs. The mobility range is measured in angle degrees using a goniometer 5. Mobility of the lumbosacral spine evaluated using the Schober test. While the patient is in a standing position, the examiner marks 2 points on the patient’s skin: at 10 cm above the line connecting the posterior superior iliac spines, and then at 5 cm below that line. The patient then slowly bends down as far as possible, while keeping the knees straight. The measurement is made using a tape measure. The obtained result is recorded with an accuracy of up to 0.5 cm
Completion date	31/08/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Total final enrolment	80
Key inclusion criteria	1. Patients with discopathy of the L5-S1 spine segment with chronic pain lasting more than three months (diagnosis based on magnetic resonance imaging examination to determine the advancement of degenerative and inflammatory changes of the lumbar region [> Modic III])
Key exclusion criteria	1. Acute low back pain 2. Sciatica episodes 3. Degenerative changes of cervical or thoracic region (individuals with lesions I° and II° according to Modic classification will not be excluded from the study, only degeneration III° will be a basis for exclusion) 4. Past fractures of the bone structures of the spine; spinal surgery 5. Cancer 6. Vertebra forward dislocation 7. Rheumatoid arthritis and ankylosing spondylitis 8. Cauda equina syndrome 9. Pregnancy 10. Acute and chronic cardiovascular diseases 11. Arrhythmia and pacemaker 12. Metal implants 13. Dermatological conditions in the area of ESWT application 14. Sensory deficits 15. Psychiatric disorders 16. Immunological diseases 17. Infections 18. Chronic drug use 19. Problems with the balance system 20. Central nervous system diseases
Date of first enrolment	16/12/2019
Date of final enrolment	10/02/2020

Locations

Countries of recruitment

Poland

Study participating centre

Opole Medical School

68 Katowicka Street
Opole
45-060
Poland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (j.taradaj@awf.katowice.pl)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/06/2022	13/06/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/06/2022: Publication reference added.
14/02/2022: The intention to publish date has been changed from 01/02/2022 to 01/08/2022.
13/06/2021: The intention to publish date has been changed from 01/02/2021 to 01/02/2022.
17/08/2020: Total final enrolment number added.
21/04/2020: The recruitment end date was changed from 30/05/2020 to 10/02/2020.
22/11/2019: Trial’s existence confirmed by Opole Medical School