NCT03066674

Brief Summary

Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP. The objectives of this study are to determine the effect of the hands-on McKenzie program on pain, disability, spine mobility, and posture deviations in subjects with derangement low back pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

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

Timeline
Completed

Started Jan 2016

Status
completed

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

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

February 23, 2017

Last Update Submit

August 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Numerical Rating Scale (PNRS).

    For assessing the pain in the low back.

    Two weeks

Secondary Outcomes (4)

  • Spine mobility

    Two weeks

  • Centralization or non-centralizer (Peripheralization) of patient symptoms.

    Two weeks.

  • Postural alterations.

    Two weeks

  • Disability associated with LBP

    Two weeks

Study Arms (2)

McKenzie group

EXPERIMENTAL

This group will receive Hand-on technique on the lumbar spine.

Other: McKenzie group

Control group

EXPERIMENTAL

The Group will not receive Hand-on technique on the lumbar spine.

Other: Control group

Interventions

Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.

McKenzie group

TENS,Exercises,Postural education ,Home exercises program.

Also known as: without any Hand -on Technique.
Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible.

You may not qualify if:

  • Participants who are underweight (BMI \< 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • LINA A ALBANAWI, MASTER

    Imam Abdulrahman Bin Faisal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

February 23, 2017

First Posted

February 28, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08