Back to resultsSEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN
Primary Purpose
Segmental Stabilization, Generalized Segmental Stabilization Exercises
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Segmental stabilization
Generalized Lumber stabilization exercsies
Sponsored by
About this trial
This is an interventional treatment trial for Segmental Stabilization
Eligibility Criteria
Inclusion Criteria:
- Both males and females will be included in the study
Exclusion Criteria:
- Age limits of subjects will be between 15 to 60
Sites / Locations
- Isra institute of rehabilitation sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Segmental Stabilization
General lumber stabilization exercises
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
VAS
Visual analogue scale for Pain 0= no pain, 10= unbearable pain
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.
International physical activity questionnaire
It is used to measure to physical activity of a person
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05075473
Brief Title
SEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN
Official Title
SEGMENTAL STABILIZATION AND GENERAL LUMBER STABILIZATION EXERCISE IN CHRONIC LOW BACK PAIN
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isra University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Segmental Stabilization, Generalized Segmental Stabilization Exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
44 patients with chronic low back pain, distributed randomly in to two groups.
Masking
Investigator
Masking Description
single
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Segmental Stabilization
Arm Type
Experimental
Arm Description
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.
Arm Title
General lumber stabilization exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Segmental stabilization
Other Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Generalized Lumber stabilization exercsies
Other Intervention Name(s)
Active comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS
Description
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.
Title
Oswestry disability Index
Description
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.
Title
International physical activity questionnaire
Description
It is used to measure to physical activity of a person
Time Frame
Only one reading is required that is the baseline reading.
Other Pre-specified Outcome Measures:
Title
ROM
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both males and females will be included in the study
Exclusion Criteria:
Age limits of subjects will be between 15 to 60
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Summaiya Zaman, Mphil
Organizational Affiliation
Isra Institute of rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isra institute of rehabilitation sciences
City
Islamabad
ZIP/Postal Code
44950
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN
We'll reach out to this number within 24 hrs