Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain

• Conditions: Mechanical Low Back Pain
• Interventions: Device: shock waves therapy

• Registration Number: NCT05088031
• Lead Sponsor: Merit University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Study Start: 2021-11-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2-Group (B): 20 patients would undergo intermittent mechanical traction	shock waves therapy	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)" 3 times weekly day after day for four weeks for a total of 12 sessions.
1- Group ( A): 20 patients underwent shock wave therapy	shock waves therapy	1-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 for 15 minutes on alternate days for four weeks for a total of 12 sessions14.
Group (C): (Control group) 20 patients would underwent conventional physical therapy	shock waves therapy	3-Group (C): (Control group) 20 patients would underwent conventional physical therapy consisted of "hyperthermia using hot packs (20 minutes), ultrasound (5 minutes), and electrotherapy using TENS (15 minutes) in addition to stretching exercises for the back, iliopsoas, and hamstring muscles and strengthening exercises for the abdominal muscles for 30 minutes".

Primary Outcome Measures

Name	Time	Method
McGill Pain Questionnaire for pain assessment	1 hour	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)

Secondary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire (RMDQ)	1 hour	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.

Trial Locations

Locations (1)

Ahmed Abd El Rahim; 🇪🇬 Sohag, Egypt