Effects of Eldoa Versus Meckenzie Exercise on Non-specific Low Back Pain Patients
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mckenzie extension exercise
Eldoa stretch technique
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Gender (Female)
- Age (40-69)
- NPRS (Grade <3)
- Chronic pain (more than or equal to 3 months)
- Restricted ROM
- Lumbar straightening
Exclusion Criteria:
- Any other orthopedic or neurological condition of hip or lumbar spine.
- sign and symptoms of lower motor neuron disease.
- Current use of medication prescribed for pain.
- Radiculopathy.
- malignancy.
- Fracture.
- Lumbar trauma.
- Disc pathology
Sites / Locations
- Rawal General And Dental Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mckenzie extension exercise
Eldoa stretch technique
Arm Description
Outcomes
Primary Outcome Measures
lumbar ROM by inclinometer.
Flexion 60 Extension 25 Left Lat Flex 25 Right Lat Flex 25
Lumbar Posture by flexicurve ruler.
Excessive lordosis (EL) is over 75°, normal lordosis (NL) is 40°, hypo-lordosis (HL) is in the 20°
Secondary Outcome Measures
pain on Numeric pain rating scale.
Changes from baseline, Pain was measured through Numeric pain rating scale.It comprises of a continuous scale of 10cm line.0 to 1 represent no pain, 1 to 3 represent mild pain ,4 to 6 represent moderate pain, 7 to 10 represent severe pain.
functional outcome by Oswestry low back pain disability questionnaire.
0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%:These patients are either bed-bound or exaggerating their symptoms
Full Information
NCT ID
NCT05239247
First Posted
February 1, 2022
Last Updated
April 15, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05239247
Brief Title
Effects of Eldoa Versus Meckenzie Exercise on Non-specific Low Back Pain Patients
Official Title
Effects of Eldoa Versus Meckenzie Exercise on Non-specific Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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
To determine the effects of Eldoa and Mckenzie exercises in posture. To determine the effects of Eldoa and Mckenzie exercises in ROM.
Detailed Description
To determine the effects of Eldoa and Mckenzie exercises in pain. To determine the effects of Eldoa and Mckenzie exercises in Quality of life.
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
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mckenzie extension exercise
Arm Type
Experimental
Arm Title
Eldoa stretch technique
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mckenzie extension exercise
Intervention Description
Hot pack applied on lumbar region for (ten minute). Mckenzie extension exercise performed 02 sets of 05 repetitions with 45 second hold and 15 sec rest between each set once a day.
TENS is applied on lumbar region for (ten minutes).
Intervention Type
Other
Intervention Name(s)
Eldoa stretch technique
Intervention Description
Hot pack applied on lumbar region for (ten minute). Eldoa stretch performed 02 sets of 05 repetitions with 45 second hold and 15 second rest between each set once a day.
TENS is applied on lumbar region for (ten minutes).
Primary Outcome Measure Information:
Title
lumbar ROM by inclinometer.
Description
Flexion 60 Extension 25 Left Lat Flex 25 Right Lat Flex 25
Time Frame
12 days
Title
Lumbar Posture by flexicurve ruler.
Description
Excessive lordosis (EL) is over 75°, normal lordosis (NL) is 40°, hypo-lordosis (HL) is in the 20°
Time Frame
12 days
Secondary Outcome Measure Information:
Title
pain on Numeric pain rating scale.
Description
Changes from baseline, Pain was measured through Numeric pain rating scale.It comprises of a continuous scale of 10cm line.0 to 1 represent no pain, 1 to 3 represent mild pain ,4 to 6 represent moderate pain, 7 to 10 represent severe pain.
Time Frame
12 days
Title
functional outcome by Oswestry low back pain disability questionnaire.
Description
0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%:These patients are either bed-bound or exaggerating their symptoms
Time Frame
12 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female age between 40 -69
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gender (Female)
Age (40-69)
NPRS (Grade <3)
Chronic pain (more than or equal to 3 months)
Restricted ROM
Lumbar straightening
Exclusion Criteria:
Any other orthopedic or neurological condition of hip or lumbar spine.
sign and symptoms of lower motor neuron disease.
Current use of medication prescribed for pain.
Radiculopathy.
malignancy.
Fracture.
Lumbar trauma.
Disc pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waqar Ahmed Awan, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawal General And Dental Hospital
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Eldoa Versus Meckenzie Exercise on Non-specific Low Back Pain Patients
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