Post-laminectomy SyndromeSWTNCT05887024
Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.
A study testing Radial Extracorporeal Shock wave Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and McKenzie Back exercises in people with Post-laminectomy Syndrome, run by Marwa Mohamed Hany Sedeek Abousenna.
Trial summary
The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question: 1. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Post-laminectomy Syndrome
- What is being tested?
- Radial Extracorporeal Shock wave Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and McKenzie Back exercises
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 May 2024
- Phase
- Interventional
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring.
- Both genders will be recruited.
- Their age will range from: 30-50 years (Sharaf, et al., 2022).
- Recruited patients will be randomly assigned in to two equal groups.
- Unilateral radicular sciatica.
- Constant back pain OR aggravated by movement,
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- Restricted lumbar range of motion.
- Tenderness at the site of incision.
- Duration of symptoms: three weeks to six months postoperatively
Who cannot join
- Past history of vertebral fracture.
- Spinal cord compression.
- Vertebral tuberculosis.
- Polyneuropathy.
- Diabetic peripheral neuropathy.
- Spinal tumor.
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- Recurrent disc herniation after surgery.
- Spondylolisthesis.
- Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases.
- Potential pregnancy.
About this study
Official title: Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis
The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question:
- what is the effect of Shock Wave Therapy on low back pain and sciatica caused by post-laminectomy fibrosis? patients in the study group will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
- Conditions
- Post-laminectomy Syndrome
- Being tested
- Radial Extracorporeal Shock wave Therapy, Transcutaneous Electrical Nerve Stimulation (TENS), McKenzie Back exercises, electric heating pads
- Keywords
- Sciatica, low back pain, post-laminectomy syndrome, Radial Shock Wave Therapy
- Medical subject headings
- post laminectomy syndrome, Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock wave TherapyDevice
Shock wave therapy: (BECO) S/N 16B011375
Transcutaneous Electrical Nerve Stimulation (TENS)Device
EME (Therapic 9400) TENS
McKenzie Back exercisesProcedure or surgery
Graduated Progressive back exercise program.
electric heating padsDevice
electrical conducting heat pack.
| Study group | Role | What they receive |
|---|---|---|
| controlled | Other | thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads |
| shock wave therapy | Active comparator | thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). Receives: Device: Radial Extracorporeal Shock wave Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The VAS consisted of a 10 cm horizontal line with the description "no pain" on the far left and "worst possible pain" on the far right
Measured: 4 weeks
Secondary outcomes (4)
Pain algometry
PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA)
Measured: 4 weeks
Lumbar Range Of Motion
The BROM II
Measured: 4 weeks
The Oswestry Disability Index: (ODI)
The Oswestry disability index is a self-completed, valid tool with adequate reliability to identify changes in functional disability
Measured: 4 weeks
Sensory Nerve Conduction Study (NCS)
Sensory nerve action potentials (sensory nerve amplitude)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-laminectomy SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A. Control group (Group A) thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). B. Study group (Group B) thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Hany Sedeek Abousenna
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Marwa Mohamed Hany Sedeek Abousenna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887024
- Sponsor's protocol ID
- P.T.REC/012/004382
- Acronym
- SWT
- Status last verified
- May 2023
- First submitted
- 28 Apr 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be free to share within 6 months to 1 year after publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis
- ClinicalTrials.gov ID
- NCT05887024
- Acronym / sponsor ID
- SWT / P.T.REC/012/004382
- Conditions
- Post-laminectomy Syndrome
- Keywords
- Sciatica, low back pain, post-laminectomy syndrome, Radial Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marwa Mohamed Hany Sedeek AbousennaUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Jun 2023 (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.
The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question:
- what is the effect of Shock Wave Therapy on low back pain and sciatica caused by post-laminectomy fibrosis? patients in the study group will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A. Control group (Group A) thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). B. Study group (Group B) thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
| Arm | Type | Receives |
|---|---|---|
| controlled | Other | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Procedure: McKenzie Back exercises, Device: electric heating padsthirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). |
| shock wave therapy | Active comparator | Device: Radial Extracorporeal Shock wave Therapy, Device: Transcutaneous Electrical Nerve Stimulation (TENS), Procedure: McKenzie Back exercises, Device: electric heating padsthirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring.
- Both genders will be recruited.
- Their age will range from: 30-50 years (Sharaf, et al., 2022).
- Recruited patients will be randomly assigned in to two equal groups.
- Unilateral radicular sciatica.
Key exclusion criteria (10 listed)
- Past history of vertebral fracture.
- Spinal cord compression.
- Vertebral tuberculosis.
- Polyneuropathy.
- Diabetic peripheral neuropathy.
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 |
|---|---|---|
| Radial Extracorporeal Shock wave TherapyShock wave therapy: (BECO) S/N 16B011375 | Device | shock wave therapy |
| Transcutaneous Electrical Nerve Stimulation (TENS)EME (Therapic 9400) TENS | Device | controlled, shock wave therapy |
| McKenzie Back exercisesGraduated Progressive back exercise program. | Procedure or surgery | controlled, shock wave therapy |
| electric heating padselectrical conducting heat pack. | Device | controlled, shock wave therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 4 weeks
The VAS consisted of a 10 cm horizontal line with the description "no pain" on the far left and "worst possible pain" on the far right
4 secondary outcomes
Pain algometry
Time frame: 4 weeks
Lumbar Range Of Motion
Time frame: 4 weeks
The Oswestry Disability Index: (ODI)
Time frame: 4 weeks
Sensory Nerve Conduction Study (NCS)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Yes. The IPD will be free to share within 6 months to 1 year after publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shock wave Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and McKenzie Back exercises in people with Post-laminectomy Syndrome, run by Marwa Mohamed Hany Sedeek Abousenna.
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 9 inclusion and 10 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2023.