Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain

NCT05088031 | Unknown

• 1 other identifier: Mechanical LBP
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mechanical Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Roland Morris Disability Questionnaire (RMDQ)

  1 hour

Other Outcomes (1)

• Back Range (BROM)

  1 hour

Study Arms (3)

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.

Device: shock waves therapy

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.

Device: shock waves therapy

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".

Device: shock waves therapy

Interventions

shock waves therapy 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)"

Also known as: intermittent mechanical traction

1- Group ( A): 20 patients underwent shock wave therapy; 2-Group (B): 20 patients would undergo intermittent mechanical traction; Group (C): (Control group) 20 patients would underwent conventional physical therapy

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sixty Patients between 20 and 35 years of both genders (male and female); all subjects suffered from mechanical low back pain and were picked from the orthopedic hospital in Sohag University. The study took place from April and August 2021 there. Treatment sessions three times a week for four weeks

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merit University: lead

Study Sites (1)

Ahmed Abd El Rahim

Sohag, 82511, Egypt

Location

Related Publications (4)

• 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.

  PMID: 21982256 BACKGROUND

• 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.

  PMID: 25611735 BACKGROUND

• 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.

  PMID: 24567665 BACKGROUND

• 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.

  PMID: 25729177 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Abd El Rahim, PHD

CONTACT

01006281510; toota_1234@yahoo.com

Nadia abd el hakim, PHD

CONTACT

01099336956; dr_nadia_abdelhakiem@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 21, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

EG (1)