Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Core strengthening exercise
intensive dynamic back exercise
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria: age 20-50 years chronic low back pain (>3 months), Exclusion Criteria: Participants with low back pain related to cancer, infection, inflammatory arthropathy, high-velocity trauma, fracture low back pain associated with severe or progressive neurological deficits trauma pregnancy.
Sites / Locations
- Integral University HospitalRecruiting
- Hashim AhmedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
CSE Group
IDBE Group
Control Group
Arm Description
in addition to Conventional treatment, core strengthening exercise were given
in addition to Conventional treatment, intensive dynamic back exercise were given
Conventional Treatment
Outcomes
Primary Outcome Measures
Pain Intensity
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
functional Limitation
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Muscle Endurance
Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test. The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05708781
Brief Title
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
Official Title
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises on Pain, Muscle Strength, Endurance, and Functional Disability in Patients With Chronic Non-specific Low Back Pain. a Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Najran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.
Detailed Description
The study will be based on a three-arm parallel group randomized control design. Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CSE Group
Arm Type
Experimental
Arm Description
in addition to Conventional treatment, core strengthening exercise were given
Arm Title
IDBE Group
Arm Type
Experimental
Arm Description
in addition to Conventional treatment, intensive dynamic back exercise were given
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional Treatment
Intervention Type
Other
Intervention Name(s)
Core strengthening exercise
Intervention Description
Isolated lumbar stabilization muscle training:
Bridge track:
Dead bug track:
Quadruped Track:
Supine Track:
Side-support Track:
Prone Track:
Standing Track:
Intervention Type
Other
Intervention Name(s)
intensive dynamic back exercise
Intervention Description
Trunk lifting Prone on a couch, hips at the edge, upper part of the body free but supported by the hands against the floor. Strap fixation over the calves. With hands on the forehead, the trunk is lifted to the greatest possible extension in hips and spine. If necessary, starting with support from physical therapist. During pauses a chair in front of the couch supports the patient.
Leg lifting Standing by the end of the couch, leaning over to a prone position with the hips against the edge in 90 degree flexion, knees 45 degree and feet on the floor. Strap fixation over the chest. Straps around knees to keep legs together. Both legs are straightened and lifted to the greatest possible extension in hips and spine. Again support from physical therapist is necessary.
Pull to neck Sitting on a tool with the arms straight and abducted over the head and hands grasping a weight lever. Against sub-maximal resistance the lever is pulled behind neck and shoulders.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
Time Frame
6 Weeks
Title
functional Limitation
Description
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Time Frame
6 Weeks
Title
Muscle Endurance
Description
Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test. The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position.
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 20-50 years
chronic low back pain (>3 months),
Exclusion Criteria:
Participants with low back pain related to cancer,
infection,
inflammatory arthropathy,
high-velocity trauma,
fracture
low back pain associated with severe or progressive neurological deficits trauma
pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hashim Ahmed, PhD
Phone
+966507589062
Email
hahasan@nu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim Ahmed, PhD
Organizational Affiliation
Najran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integral University Hospital
City
Lucknow
State/Province
Uttar Pardesh
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdurraheem Khan, PhD
Facility Name
Hashim Ahmed
City
Najrān
State/Province
Najran
ZIP/Postal Code
1988
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashim Ahmed, PhD
Phone
0507589062
Email
hahasan@nu.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Core Strengthening and Intensive Dynamic Back Exercises in Patient With Low Back Pain
We'll reach out to this number within 24 hrs