Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain

Mechanical Low Back Pain Clinical Trial

Official title:

Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05088031
• Other study ID #: Mechanical LBP
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2021
• Source: Merit University
• Contact: Ahmed Abd El Rahim, PHD
• Phone: 01006281510
• Email: toota_1234[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

investigate the effect of shock wave therapy versus mechanical traction on mechanical low back pain.

Description:

Chronic low back pain (CLBP) is a common condition that causes tremendous health and socio-economic problems. CLBP is a widespread problem. About 70%-80% of adults in the general population are expected to suffer at least a low back pain episode at some time in their lives1. CLBP is the leading cause of absenteeism at work and creates restrictions on movements, lasting disabilities, and impaired quality of life. Non-specific low back pain is described as low back discomfort, which cannot be attributed to a distinct, known etiology "(e.g., infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome)" 2. Non-specific low back pain is a mechanical musculoskeletal pain that has a symptom that varies according to the physical activity nature 3. The practice of sitting with a healthy posture and preventing a protracted-standing position can often prevent simple low back pain. However, many kinds of low back pain are addressed with therapies as numerous as the causes of low back pain. The most important treatments are therapeutic measures, such as bed rest, assistive aids, traction therapy, heat, electrical stimulation, and manual therapy are the first choice treatments4. If these methods fails, invasive therapy procedures like nerve roots blocks and epidural injections are employed, and operations are carried out when no reaction to other treatments has been seen or if the disease status is critical. New conservative therapies, including extracorporeal shock wave therapy (ESWT), have recently been embraced 5.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age between (20 and 35 years)
• all subjects suffered from mechanical low back pain

Exclusion Criteria:

• Rheumatoid arthritis or backbone pathologies, and past lumbar vertebrae surgery or cancer were reported

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Device:
• shock waves therapy
Group (A): 20 patients would undergo shock waves plus traditional physical therapy. One thousand shock waves (7 times per sec) were applied at 2.5 Hz at low energy flux densities of 0.01-0.16 mJ/mm2 using a 17 mm head 2-Group (B): 20 patients would undergo intermittent mechanical traction plus conventional physical therapy. Participants would undergo 30 minutes of "mechanical traction (with 10-second pull and 5-second rest)"

Locations

Country	Name	City	State
Egypt	Ahmed Abd El Rahim	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Merit University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6. Review. — View Citation

Chung TS, Yang HE, Ahn SJ, Park JH. Herniated Lumbar Disks: Real-time MR Imaging Evaluation during Continuous Traction. Radiology. 2015 Jun;275(3):755-62. doi: 10.1148/radiol.14141400. Epub 2015 Jan 22. Erratum in: Radiology. 2015 Jun;275(3):934-5. — View Citation

Han H, Lee D, Lee S, Jeon C, Kim T. The effects of extracorporeal shock wave therapy on pain, disability, and depression of chronic low back pain patients. J Phys Ther Sci. 2015 Feb;27(2):397-9. doi: 10.1589/jpts.27.397. Epub 2015 Feb 17. — View Citation

Lee S, Lee D, Park J. Effects of extracorporeal shockwave therapy on patients with chronic low back pain and their dynamic balance ability. J Phys Ther Sci. 2014 Jan;26(1):7-10. doi: 10.1589/jpts.26.7. Epub 2014 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Back Range (BROM)	instrument is a reliable , objective approach for measuring LBR in all levels regardless of thoracic or hip movement	1 hour
Primary	McGill Pain Questionnaire for pain assessment	The quality and degree of subjective pain are evaluated. The scale comprises 4 subscales examining the sensory, affective, assessment, and other components of pain, pain-intensity responses, and a 5point scale (Present Pain Intensity)	1 hour
Secondary	Roland Morris Disability Questionnaire (RMDQ)	is a reliable, valid tool for LBP dysfunction assessment. It is one of the more often used measures to evaluate LBP patients' functional state. The RMDQ comprises 24 elements in the LBP-adapted Sickness Impact Profile. The questionnaire was scored by summing the number of 'yes' ranged from 0 (no disability) to 24, were added to the questionnaire (severe disabilities) 12.	1 hour