NCT06182826

Brief Summary

Low back pain is defined as the region of pain between the lower ribs and hips. Low back pain with respect to middle school children corresponds to the age where children and adolescents go to school for longer periods of time, having heavy bags, assuming poor postures while sitting for prolonged hours. Poor posture, prolonged sitting and lack of physical activity results in back pain that leads to poor performance in school as well as attendance.

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 low-back-pain

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable low-back-pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 13, 2023

Last Update Submit

December 13, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale.

    6 week

  • Trunk Extensor Endurance

    Trunk extensor endurance will be measured using McGill Endurance Test Battery

    6 week

  • Trunk Flexor Endurance

    Trunk flexor endurance will be measured using McGill Endurance Test Battery

    06 Week

  • Lateral Endurance

    Trunk lateral endurance will be measured using McGill Endurance Test Battery

    06 Week

Study Arms (2)

Group A

EXPERIMENTAL

Patients in this group will receive Core Stability Protocol with Routine Exercise Protocol. A total of 3 sessions per week for 6 weeks will be given.

Procedure: Core Stability protocolProcedure: Routine exercise therapy

Group B

ACTIVE COMPARATOR

Patients will receive Routine Exercise Protocol. A total of 3 sessions per week for 6 weeks will be given.

Procedure: Routine exercise therapy

Interventions

5 Minutes Warm up Hamstring stretch Back Extensor Stretch Hip Flexor Stretch Jumping Rope Stair Stepping Mountain Climbers Curl Up Side Planks Bird Dog Frequency: 3 sessions per week for six weeks. Time Duration: Approx. 30 to 45 minutes

Group A

5 Minutes Warm up Hamstring stretch Back Extensor Stretch Hip Flexor Stretch Jumping Rope Stair Stepping Mountain Climbers Frequency: 3 sessions per week for six weeks. Time Duration: Approx. 30 to 45 minutes

Group AGroup B

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Middle aged school children between age 9 and 14.
  • Both male and female.
  • Back pain of 2 or greater on NPRS

You may not qualify if:

  • Structural observational deformity (kyposis, lordosis, scoliosis)
  • History of post spinal surgery
  • Acute low back pain flare up
  • Pain or any other injury of lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

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

Arshia Salman, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single blinded randomized controlled trial having two groups. One group will be given Core Stabilization Protocol along with Routine exercise therapy whereas other group will only receive Routine Exercise therapy protocol. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 27, 2023

Study Start

August 30, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations