NCT05848076

Brief Summary

The study will be Randomized controlled trail, Subject diagnosed with low back pain meeting predetermined inclusion and exclusion criteria will be divided into two groups. Pre assessment will be done using pain and disability as subjective measurement through Numeric pain rating scale (NPRS) \& modified Oswestry disability index and the lumber range by goniometer as objective measurement. One group is subject will be treated with therapeutic neuroscience education and core stability exercise and second group is core stability exercise. Each subject received 18 sessions with 3 treatments per week. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

April 18, 2023

Last Update Submit

September 22, 2023

Conditions

Chronic Low-back Pain

Keywords

back paintherapuetic neuroscience educationrange of motion

Outcome Measures

Primary Outcomes (2)

  • Numeric pain rating scale for pain

    NPRS (numeric pain rating scale) NPRS is based on 11 points numerical rating scale for determining pain intensity, 0( no ;pain), 10 (worst pain imaginable) pain intensity

    3 weeks

  • Modified Oswestry Disability index (Disability and function)

    Modified Oswestry Disability index Urdu version of Modified Oswestry Disability Index has become one of the principal condition-specific outcome measures used in the management of spinal disorders. At the baseline assessment, following each exercise session during the 12-week intervention, and finally at the end of the intervention programme, the MODI scores will be recorded

    3 weeks

Secondary Outcomes (1)

  • Goniometer (Range of Motion)

    3 weeks

Study Arms (2)

TNE with core stability

EXPERIMENTAL

Group A (TNE WITH CORE STABILITY) on low back this McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explain the patient about their pain.The study participants will receive the total 18 session over 6 weeks period consider 3 treatment session per week

Other: TNEOther: core stability

Core stability

ACTIVE COMPARATOR

McGill exercises for the low back. involved 3 sets of 3 repetitions for each muscle with a 30-second hold and 30-second rest interval for each repetition. The researcher will reassess the patient. Post treatment patient will complete Numeric Pain Rating Scale (NPRs), range of motion (Goniometer and Oswestry disability index (ODI). All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week.

Other: core stability

Interventions

TNEOTHER

McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explains the patient about their pain

TNE with core stability
core stabilityOTHER

McGill exercises for the low back.

Core stabilityTNE with core stability

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diffused chronic low back pain
  • Stop movement due to fear of increasing pain
  • Anxiety and sleep problem with CLBP
  • Symptoms duration most of days in 6 months
  • No treatment other than analgesics

You may not qualify if:

  • Diabetes mellites
  • Radiating pain
  • Spine surgery, fracture, arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Headquarter Hospital Layyah

Layyah, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Back Pain

Interventions

Core Stability

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Muhammad Sanaullah, MS

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

  • Ume Habiba

    Study Principle Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: blinding
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 8, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)