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CompletedNCT05075473Updated Oct 12, 2021

SEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN

An interventional study of Segmental stabilization and Generalized Lumber stabilization exercsies in Segmental Stabilization and Generalized Segmental Stabilization Exercises, sponsored by Isra University. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by Isra University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

It will be randomized control trial with 60 patients with chronic low back pain divided into 2 groups. One group will be given segmental stabilization whose purpose is to achieve segmental control over primary stabilizers. Second group will be given just generalized lumber stabilization exercises as it includes close chain exercises with low velocity as well as low load. This study will be conducted in Rehabilitation setup of Benazir Bhutto hospital Rawalpindi and IIRS that is Rehabilitation dept. at Al Nafees medical college and hospital, Islamabad. Non probability Convenience Sampling technique will be utilized

02

Conditions studied

  • Segmental Stabilization
  • Generalized Segmental Stabilization Exercises
03

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Both males and females will be included in the study

Exclusion criteria

Exclusion Criteria:

  • Age limits of subjects will be between 15 to 60
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Segmental Stabilization

    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

  • Active comparator
    General lumber stabilization exercises

    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

  • OtherSegmental stabilization

    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

  • OtherGeneralized Lumber stabilization exercsies

    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

05

What researchers measure

Primary outcomes

  1. VAS

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

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. International physical activity questionnaire

    It is used to measure to physical activity of a person

    Time frame: Only one reading is required that is the baseline reading.

Other outcomes

  1. ROM

    It is an acronym of Range of motion

    Time frame: 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.

06

Study locations

1 site
  • Isra institute of rehabilitation sciences
    Islamabad, 44950, Pakistan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05075473
Lead sponsor
Isra University
Responsible party
Sponsor
First posted
Oct 12, 2021
Start date
Mar 26, 2019
Primary completion
Nov 11, 2020
Completion
Dec 11, 2020
Last update
Oct 12, 2021

Study contacts

Dr. Summaiya Zaman, Mphil
principal investigator · Isra Institute of rehabilitation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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