NCT05314049

Brief Summary

Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.

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
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable low-back-pain

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

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 29, 2022

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Back Pain

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

    2 weeks

  • Lumbar Range of Motion

    Disability 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

Study Arms (2)

Experimental Group

EXPERIMENTAL
Procedure: Mckenzie Extension ProtocolProcedure: Lumbar SNAGsDevice: inferential therapyDevice: Heat Therapy

Active Comparator Group

ACTIVE COMPARATOR
Procedure: Mckenzie Extension ProtocolDevice: inferential therapyDevice: Heat Therapy

Interventions

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

Active Comparator GroupExperimental Group
Lumbar SNAGsPROCEDURE

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

Experimental Group

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

Active Comparator GroupExperimental Group

superficial heating for 20 minutes

Active Comparator GroupExperimental Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

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

Central Study Contacts

Muhammad Osama, PhD*

CONTACT

Muhammad Osama, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

May 1, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share