NCT05326594

Brief Summary

Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

March 29, 2022

Last Update Submit

February 26, 2024

Conditions

Low Back PainDisk Prolapse

Outcome Measures

Primary Outcomes (8)

  • Back Pain

    Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.

    2 weeks

  • Lumbar Range of Motion

    Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome.

    2 weeks

  • Postural Stability

    Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.

    2 weeks

  • Lumbar Disability

    Disability will be measured via Oswestry Disability Index.

    2 weeks

  • Step length

    Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome

    2 weeks

  • Stride length

    Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome

    2 weeks

  • Gait velocity

    Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome

    2 weeks

  • Disc Height

    Disc will be analyzed using Magnetic Resonance Imaging

    2 weeks

Study Arms (1)

Physical Therapy

EXPERIMENTAL
Procedure: Mckenzie Extension ProtocolProcedure: Lumbar SNAGsDevice: Inferential therapyProcedure: Heat Therapy

Interventions

Mckenzie Extension ProtocolPROCEDURE

Mckenzie Extension Exercise Protocol will be performed by participants in prone position

Physical Therapy
Lumbar SNAGsPROCEDURE

Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position

Physical Therapy
Inferential therapyDEVICE

4 pole inferential therapy in combination with superficial heating for 20 minutes

Physical Therapy
Heat TherapyPROCEDURE

superficial heating for 20 minutes

Physical Therapy

Eligibility Criteria

Age18 Months - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both male and female participants
  • Aged 18-50 years old
  • low back pain intensity less than 80/100mm on visual analogue scale
  • positive centralization phenomenon
  • low signal intensity of IV disc on T2 - weighted MRI
  • high intensity zone towards the posterior aspect of the disc on MRI

You may not qualify if:

  • Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, 66000, Pakistan

Location

Related Publications (1)

  • Osama M, Naeem A, Tariq S, Mushtaq S, Siddiqi FA, Afridi S. Effects of physical therapy on improving disc height index, postural stability, pain and function in persons with discogenic low back pain. J Pak Med Assoc. 2025 Mar;75(3):378-382. doi: 10.47391/JPMA.20384.

    PMID: 40143467DERIVED

MeSH Terms

Conditions

Low Back PainIntervertebral Disc Displacement

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Muhammad Osama, PhD*

    FUI

    PRINCIPAL INVESTIGATOR

  • Aamer Naeem, PhD*

    FUI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 13, 2022

Study Start

May 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)