NCT06524531

Brief Summary

This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. The trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 10, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 23, 2024

Last Update Submit

September 2, 2024

Conditions

Multi-Organ Disorder

Outcome Measures

Primary Outcomes (16)

  • Pain Visual Analog Scale (0-10)

    Change in pain intensity from baseline

    2 Weeks

  • Pain Visual Analog Scale (0-10)

    Change in pain intensity from baseline

    3 Months

  • Pain Visual Analog Scale (0-10)

    Change in pain intensity from baseline

    6 Months

  • Pain Visual Analog Scale (0-10)

    Change in pain intensity from baseline

    1 Year

  • Oswestry Disability Index (0-50)

    Change in disability index from baseline

    2 Weeks

  • Oswestry Disability Index (0-50)

    Change in disability index from baseline

    3 Months

  • Oswestry Disability Index (0-50)

    Change in disability index from baseline

    6 Months

  • Oswestry Disability Index (0-50)

    Change in disability index from baseline

    1 Year

  • Hospital Anxiety and Depression Scale (0-14)

    Change in anxiety and depression levels from baseline

    2 Weeks

  • Hospital Anxiety and Depression Scale (0-14)

    Change in anxiety and depression levels from baseline

    3 Months

  • Hospital Anxiety and Depression Scale (0-14)

    Change in anxiety and depression levels from baseline

    6 Months

  • Hospital Anxiety and Depression Scale (0-14)

    Change in anxiety and depression levels from baseline

    1 Year

  • Quality of Life (0-100)

    Change in Quality of life from baseline

    2 Weeks

  • Quality of Life (0-100)

    Change in Quality of life from baseline

    3 Months

  • Quality of Life (0-100)

    Change in Quality of life from baseline

    6 Months

  • Quality of Life (0-100)

    Change in Quality of life from baseline

    1 Year

Study Arms (2)

Experimental Group

EXPERIMENTAL

Pulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each. Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen.

Procedure: Pulsed RF NeuromodulationBiological: Leukocyte-Rich PRP Injection

Control Group

EXPERIMENTAL

Physiotherapy: Standard physiotherapy regimen only

Procedure: Physiotherapy Alone

Interventions

Pulsed RF NeuromodulationPROCEDURE

RF neuromodulation will be applied to the L2 and L3 segments bilaterally. Each segment will receive treatment for 6 minutes, either sequentially or simultaneously on both sides.

Experimental Group
Leukocyte-Rich PRP InjectionBIOLOGICAL

Leukocyte-rich PRP will be prepared from the patient's blood and injected into the multifidus muscle at the L2 and L3 levels.

Experimental Group
Physiotherapy AlonePROCEDURE

Standard physiotherapy regimen tailored to each participant's needs. This may include exercises to improve flexibility, strength, and endurance of the back muscles, as well as education on posture and body mechanics.

Control Group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory low back pain due to multifidus dysfunction.
  • Pain persisting for more than 6 months despite conventional treatments.
  • Ability to provide informed consent.

You may not qualify if:

  • Previous spinal surgery within the last year.
  • Current use of systemic steroids or immunosuppressive medications.
  • Known bleeding disorders or anticoagulant therapy.
  • Pregnancy or lactation.
  • Severe psychiatric or cognitive disorders.
  • Any Congenital or Non-congenital disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iffat Anwar Medical Complex

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 29, 2024

Study Start

July 10, 2024

Primary Completion

July 10, 2025

Study Completion

December 30, 2025

Last Updated

September 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)