Mechanical Low Back PainNCT05088031
Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain
An observational study of Mechanical Low Back Pain, run by Merit University at 1 site in Egypt.
Trial summary
investigate the effect of shock wave therapy versus mechanical traction on mechanical low back pain. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- shock waves therapy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Age between (20 and 35 years)
- all subjects suffered from mechanical low back pain
Who cannot join
- Rheumatoid arthritis or backbone pathologies, and past lumbar vertebrae surgery or cancer were reported
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ahmed Abd El Rahim
Sohag, 82511
mohamed Essa, PHD, 01285584224, mohamedmohamed1990mohamed@yahoo.com
About this study
investigate the effect of shock wave therapy versus mechanical traction on mechanical low back pain.
Read the 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.
- Conditions
- Mechanical Low Back Pain
- Being tested
- shock waves therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock waves therapyDevice
Also called intermittent mechanical traction
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)"
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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". Receives: Device: shock waves therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Assem, Merit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088031
- Sponsor's protocol ID
- Mechanical LBP
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21982256Chung 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.
PubMed 25611735Lee 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.
PubMed 24567665Han 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.
PubMed 25729177
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05088031
- Acronym / sponsor ID
- Mechanical LBP
- Conditions
- Mechanical Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Merit UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- Group ( A): 20 patients underwent shock wave therapy | – | Device: shock waves therapy1-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. |
| 2-Group (B): 20 patients would undergo intermittent mechanical traction | – | Device: shock waves therapy2-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. |
| Group (C): (Control group) 20 patients would underwent conventional physical therapy | – | Device: shock waves therapy3-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". |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- Age between (20 and 35 years)
- all subjects suffered from mechanical low back pain
Key exclusion criteria (1 listed)
- Rheumatoid arthritis or backbone pathologies, and past lumbar vertebrae surgery or cancer were reported
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shock waves therapyAlso: intermittent mechanical tractionGroup (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)" | Device | 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 |
Primary outcome
McGill Pain Questionnaire for pain assessment
Time frame: 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)
1 secondary outcome
Roland Morris Disability Questionnaire (RMDQ)
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 21982256Balague 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.
- Background: PubMed 25611735Chung 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.
- Background: PubMed 24567665Lee 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.
- Background: PubMed 25729177Han 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Low Back Pain, run by Merit University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abd El Rahim, PHD (01006281510, toota_1234@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Pain Questionnaire for pain assessment (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088031, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.