NCT05257421

Brief Summary

the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. After signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group. Hypothesis: The hypothesis of this study states that: o Research hypothesis: there will be a significant difference between the radial ESWT and back exercises in reducing LBP

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

February 16, 2022

Last Update Submit

February 25, 2022

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (3)

  • pressure-pain threshold

    Algometry device will be used to measure three thresholds' values: * Tenderness threshold. * Referred pain threshold. * Pain tolerance threshold.

    45 hour session

  • The Oswestry Disability Index

    is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability, scoring from 0 to 50, the lower score the better

    45 minutes session

  • Numerical pain scale

    0-10 the lower the better

    45 minutes session

Secondary Outcomes (1)

  • ROM of the back

    45 minutes session

Study Arms (3)

shockwave group

EXPERIMENTAL
Device: shockwave machine

exercise group

ACTIVE COMPARATOR
Other: leg and back exercises

combined group

ACTIVE COMPARATOR
Combination Product: shockwave and exercises

Interventions

shockwave machineDEVICE

shockwave therapy. 2000 impulses will be applied, 1000 on the TrPs and 1000 surrounding it, with Energy level up to 2,5 bars and frequency of 10Hz

shockwave group
leg and back exercisesOTHER

the exercise program will include 5 exercises that focuses on the back and lower limbs. These exercises are: * Bridge * Plank * Squat * Push-ups * Back extension Each exercise will be done for 3-5 sets.

exercise group
shockwave and exercisesCOMBINATION_PRODUCT

both types of interventions will be applied for the patient

combined group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Only male patients will be included.
  • Age 20-40 years old.
  • Non-specific LBP for at least 3 months.
  • At least one local tenderness or active trigger point in the anatomical region of the QL muscle.
  • Pain intensity on numerical pain scale should be more than 4

You may not qualify if:

  • LBP due to a pathology or trauma.
  • Below 20 years of age.
  • Previous lumbar surgeries.
  • Malignancy.
  • Patients under medications or painkillers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Epidemiological features of chronic low-back pain

    BACKGROUND

  • Joshi S, Sheth M. Effect of extracorporeal shockwave therapy on myofascial pain syndrome of upper trapezius: A systematic review. Int J Med Sci Public Health. 2020;9(10):1.

    BACKGROUND

  • Effect of Static Versus Dynamic Ultrasound on Pain in Subjects with Trigger Point in Quadratus Lumborum Having Non-Specific Chronic Low Back. 2020;10(December):263-9.

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

maram makki

CONTACT

+971567288781mmarram95@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist / master student

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

May 1, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

March 14, 2022

Record last verified: 2022-02