Effect of Shockwave Therapy on Post-laminectomy Fibrosis... | NCT05887024

Studies
Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.

NCT05887024

Sponsor

Marwa Mohamed Hany Sedeek Abousenna

Status

Unknown status

Last Update Posted

Jun 2, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Post-laminectomy Syndrome

Interventions

Radial Extracorporeal Shock wave Therapy
Transcutaneous Electrical Nerve Stimulation (TENS)
McKenzie Back exercises
electric heating pads

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Estimated

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Apr 28, 2023

First Submission Date that Met QC Criteria

May 31, 2023

First Posted Date

Jun 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2023

Last Update Posted Date

Jun 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marwa Mohamed Hany Sedeek Abousenna, physiotherapist Marwa Mohamed Hany Sedeek Abousenna, Cairo UniversitySponsor-Investigator

Lead Sponsor

Marwa Mohamed Hany Sedeek AbousennaOTHER

Collaborators

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
controlled	Other	thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).	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).	Device: Radial Extracorporeal Shock wave Therapy Device: Transcutaneous Electrical Nerve Stimulation (TENS) Procedure: McKenzie Back exercises Device: electric heating pads

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radial Extracorporeal Shock wave Therapy	Device	Shock wave therapy: (BECO) S/N 16B011375	shock wave therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pain algometry	PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA)	4 weeks
Lumbar Range Of Motion	The BROM II	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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,
Restricted lumbar range of motion.
Tenderness at the site of incision.
Duration of symptoms: three weeks to six months postoperatively

Exclusion Criteria:

Past history of vertebral fracture.
Spinal cord compression.
Vertebral tuberculosis.
Polyneuropathy.
Diabetic peripheral neuropathy.
Spinal tumor.
Recurrent disc herniation after surgery.
Spondylolisthesis.
Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases.
Potential pregnancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The IPD will be free to share within 6 months to 1 year after publication.

Types

Study Protocol

Time Frame

6 months to 1 year after publication.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C000711512	post laminectomy syndrome
D012585	Sciatica
D017116	Low Back Pain

Ancestor Terms

ID	Term
D020426	Sciatic Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004561	Transcutaneous Electric Nerve Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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).