Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain

NCT ID: NCT05088031

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Mechanical Low Back Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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1- Group ( A): 20 patients underwent shock wave 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.

shock waves therapy

Intervention Type DEVICE

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)"

2-Group (B): 20 patients would undergo intermittent mechanical traction

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.

shock waves therapy

Intervention Type DEVICE

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)"

Group (C): (Control group) 20 patients would underwent conventional physical 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".

shock waves therapy

Intervention Type DEVICE

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)"

Interventions

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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)"

Intervention Type DEVICE

Other Intervention Names

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intermittent mechanical traction

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merit University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Assem

Lecturer of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abd El Rahim

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Abd El Rahim, PHD

Role: CONTACT

01006281510

Nadia abd el hakim, PHD

Role: CONTACT

01099336956

Facility Contacts

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mohamed Essa, PHD

Role: primary

01285584224

References

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Balague F, Mannion AF, Pellise 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.

Reference Type BACKGROUND
PMID: 21982256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25611735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24567665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25729177 (View on PubMed)

Other Identifiers

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Mechanical LBP

Identifier Type: -

Identifier Source: org_study_id