NCT05075473

Brief Summary

Chronic low back pain effects more than 50% of general population. It's prevalence is higher is young adults that are economically active adults. Its significance is often underestimated because usually young adults ignore these initial episodes of low back pain due to their busy life style or life full of commitments. Approximately 70% of adults have at least one episode of low back pain during their lifetimes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
Last Updated

October 12, 2021

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

April 9, 2020

Last Update Submit

October 9, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • VAS

    Visual analogue scale for Pain 0= no pain, 10= unbearable pain

    4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.

  • Oswestry disability Index

    It is used to measure permanent functional disability. For each section, total possible score is 5, after completing all 10 sections. sum of all scores will be obtained in the form of percentages.

    4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.

  • International physical activity questionnaire

    It is used to measure to physical activity of a person

    Only one reading is required that is the baseline reading.

Other Outcomes (1)

  • ROM

    4 weeks (1st reading is at the baseline, 2nd is at 3rd day, 3rd is at 5th day, 4th is at 8th day, 5th is at 10th day, 6th is at 12th day, 7th is at 19th day and 8th reading is at 26th day.

Study Arms (2)

Segmental Stabilization

EXPERIMENTAL

Segmental control over the primary stabilizers (TrA, deep multifidus, pelvic floor and diaphram) is maintained. Weight of body is minimized by using drawing in maneuver. Time duration will be of 30 to 40 mins, thrice a week for four weeks. Hot packs will be applied for 10 mins. In starting days, 8 to 10 reps with hold time 5 count. In later days, 12 to 15 reps with hold time increases up till 10 to 15 counts.

Other: Segmental stabilization

General lumber stabilization exercises

ACTIVE COMPARATOR

It includes exercises in closed chain with low velocity as well as low load. Time duration will be of 30 to 40 mins, thrice a week for four weeks. Hot packs will be applied for about 10 mins. In starting days, 8 to 10 reps with hold time 5 count. In later days, 12 to 15 reps with hold time increases up till 10 to 15 counts.

Other: Generalized Lumber stabilization exercsies

Interventions

Physiotherapist will perform activation of multifidus in prone position. It also includes activation of transverse abdominas in crook lying position, in sitting as well as in point kneeling position to re-establish simultaneous contraction of deep muscles synergy.

Also known as: Experimental
Segmental Stabilization

It can by performed by patient him or her self under physiotherapist's assistance. Lumber neutral position is maintained. Bridging in prone as well as supine position will be maintained.

Also known as: Active comparator
General lumber stabilization exercises

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both males and females will be included in the study

You may not qualify if:

  • Age limits of subjects will be between 15 to 60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isra institute of rehabilitation sciences

Islamabad, 44950, Pakistan

Location

Study Officials

  • Dr. Summaiya Zaman, Mphil

    Isra Institute of rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
single
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 44 patients with chronic low back pain, distributed randomly in to two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

October 12, 2021

Study Start

March 26, 2019

Primary Completion

November 11, 2020

Study Completion

December 11, 2020

Last Updated

October 12, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations