NCT05673616

Brief Summary

In the rehabilitation department, we are working with patients of low back pain for routine management and as well as for research. Still now, the biomechanical ground proofing the beneficial effects of McKenzie Mechanical diagnosis and therapy on non-mechanical low back pain has not been studied in depth. This qausi-experimental study will provide expert-level evidence using gold standard MRI findings to add McKenzie MDT in routine treatment of the condition.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 4, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 4, 2023

Last Update Submit

January 5, 2023

Conditions

Keywords

Physical therapy; Intervertebral disc; Magnetic resonance imaging; Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • MRI changes

    fatty infiltration and modic changes

    At baseline and 4 weeks

Secondary Outcomes (2)

  • Pain intensity assessed by numeric pain rating scale

    At baseline and 4 weeks

  • Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)

    At baseline and 4 weeks

Study Arms (1)

Interventional group

EXPERIMENTAL

Mckenzie Extension Exercises

Other: Mckenzie Extension Exercises

Interventions

After two weeks of initial consultation, the patient will be taught to perform slouch-overcorrect on day 1 followed by flexion on day 2 in lying position and accompanied by flexion for 5 days in sitting position and finally flexion in standing will be performed. The exercises will be repeated for 10 times and followed by extension in standing exercises.

Interventional group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders having low back pain. Patients having modic changes in MRI. Otherwise healthy patients with age range from 18 - 55 years.

You may not qualify if:

  • Patients with non-mechanical LBP Patients not meeting age range Patients with any major co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Madiha Ashfaq, DPT, MS-CPPT

CONTACT

Sidra Qureshi, DPT,MS-WHPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Inclusion Criteria 1. Patients having Discogenic LBP referred from hospital. 2. Male and female both 3. Ptients hving Modic changes in MRI. 3.Otherwise, healthy patients with age range from 18 to 55 years. Exclusion criteria: 1. Patients with non-mechanical LBP 2. Patients not meeting age range 3. Patients with any major co-morbidity 4. Any type of systemic illness
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 6, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

January 6, 2023

Record last verified: 2023-01

Locations