Effects of ELDOA on Hamstring Tightness
Primary Purpose
Non-specific Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire
Group B: Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Non-specific Low Back Pain focused on measuring ELDOA, LBP, ROM, Flexibility, ODI
Eligibility Criteria
Inclusion Criteria:
- Low back pain for at least 2 months.
- A passive SLR angle of 70° or less.
- Both genders.
- 25-40 years age.
- Pain > 3 on NPRS
Exclusion Criteria:
- Any fracture of spine or lower limb.
- No neurological signs.
- Malignancy, infection, trauma or any bony deformity.
- Surgery of spine or lower limb.
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire (ELDOA)
Group B: Conventional treatment
Arm Description
Participants will receive conventional treatment along with ELDOA stretching exercises protocol at L5, S1.
Participants will receive only conventional treatment (Control)
Outcomes
Primary Outcome Measures
Sit and Reach Test
Used for measurement of flexibility of the lower back and hamstring muscles.The reliability with ICC= 0.99 Baseline,6th visit,12th visit
Straight Leg Raise Passive Knee Extension Test (PKE)
Examine the joint range and its quality of movement; in particular, the 'end feel' of the joint.It has excellent test-retest reliability with ICC=0.94 and moderate validity= 0.57 to 0.63 Baseline,6th visit,12th visit
The Oswestry Disability Index (ODI)
Tool used to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). The ODI score is recommended as a back pain-specific measure of disability. Reliability with ICC= 0.85 and validity=0.77 Baseline,6th visit,12th visit
Secondary Outcome Measures
Numeric pain rating scale
A scale for pain measurement, ranging from '0' representing no pain to '10' representing the worst or severe pain. The reliability with ICC= 0.64 to 0.86 Baseline,6th visit,12th visit
Inclinometer
It is an instrument used to measure range of motion (ROM) (36). The inter rater reliability with ICC= 0.80 Baseline,6th visit,12th visit
Full Information
NCT ID
NCT04757441
First Posted
February 2, 2021
Last Updated
May 1, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04757441
Brief Title
Effects of ELDOA on Hamstring Tightness
Official Title
Effects of ELDOA on Hamstring Tightness in Individuals With Non-Specific Low Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 19, 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
The purpose of this study is to find the effects of ELDOA in increasing hamstring length in patients with nonspecific low back pain.This research will bring awareness about the concept of ELDOA exercises among clinicians and people to understand its benefits for treating back pain issues. Further, it will provide an important addition to the evidence-based treatment intervention of ELDOA
Detailed Description
Low back pain is the most commonly reported musculoskeletal condition, associated with injury and disability in adults worldwide. It is the leading cause of activity limitation and work absence throughout much of the world . Over 70% to 80% people experience low back pain somewhat once in their lives . Low back pain affects people of all ages, from children to the elderly, but it is more prevalent in young adults. Low back pain can lead to decrease in lumbar range of motion, change in gait pattern, and change of rhythm in the pelvis, limitations that can restrict social activities. Approximately more than 85% low back pain cases are categorized as non specific low back pain. Non-specific low back pain is defined as low back pain not attributable to a recognizable, known specific pathology (e.g, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome) Hamstrings muscle is a postural muscle and as it is biarticular, it has tendency to shorten even under normal circumstances . Hamstrings are more prone to adaptive shortening than all other muscles of body .prevalence and incidences of Hamstrings tightness in non-specific low back pain individuals is high due to limited activity and lack of regular exercise . The hamstrings length is an essential component in the basic movements of the human body like walking and running . It is composed of three separate muscles; include semitendinosus, semimembranosus and biceps femoris which are present in the posterior part of thigh and help in the flexion of knee and extension of hip joint . Due to the attachment of hamstring muscles to the ischial tuberosity, the tightness of the hamstring produces posterior pelvic tilt which stops the flexion of hips during forward bending so reducing the lordosis of the lumbar spine. It may impair spinal loading and alter the Lumbar Pelvic Rhythm which will generate more strain on the lumbar segment giving rise to low back pain.
ELDOA stands for elongation Longitudinaux avec Decoaption Osteo-Articulaire, or LOADS (Longitudinal Osteo-Articular Decoaption Stretching). A system of exercises and movements that uses the center of gravity and locates a target area of the spine that needs to be either mobilized or re-aligned by placing and maintaining tension on the fascia, was developed by Guy Voyer in Europe more than 30 years ago . The purpose of ELDOA is to help manage stress and create space in the vertebral joints, allowing muscles to move freely. The results of these stretches include joint mobility, increased absorption of fluid within the discs of the spine, flexibility, improved muscle tone, postural alignment, body-mind connection, and coordination. The tension and release created by these stretches help normalize the posture.
In March-June 2019, a quasi- experimental study of 34 participants was conducted on Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Lumbar Disc Protrusion. Two randomized group of patients with lumbar disc protrusion were treated and concluded that ELDOA improved pain and functional status of patients .
In Jan-June 2019, another quasi-experimental study conducted with 20 patients, Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) in Cervical Disc Protrusion. ELDOA technique was compared with conventional physical therapy treatment. The results showed, improved functional status and pain.
In May 2019, an article published in Dynamic Chiropractic, Cervical spine degeneration- Exam to ELDOA founded significant results on using ELDOA exercises as main treatment intervention for cervical spine degeneration.
In 2019, A study inquired the combination effect of core stability and contract relax exercise on hamstring flexibility and concluded that the combination of both core stability and contract relax exercise better than core stability exercises only and as good as contract relax exercises in increasing hamstring flexibility
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
Keywords
ELDOA, LBP, ROM, Flexibility, ODI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire (ELDOA)
Arm Type
Experimental
Arm Description
Participants will receive conventional treatment along with ELDOA stretching exercises protocol at L5, S1.
Arm Title
Group B: Conventional treatment
Arm Type
Other
Arm Description
Participants will receive only conventional treatment (Control)
Intervention Type
Other
Intervention Name(s)
Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire
Intervention Description
ELDOA position for L5, S1 level Patient will ask to lie on his back, wedge buttocks in the corner of wall and raise his legs. Then Stretch the legs and push the heels toward ceiling. Extend the spine and stretch the arms above head .
• Patient will hold this position for one minute and repeat it for 4 -5 times.
Conventional treatment will include:
Hot pack for 15 minutes .
TENS for 10 minutes .
self stretching of hamstrings
Intervention Type
Other
Intervention Name(s)
Group B: Conventional treatment
Intervention Description
Participants will receive only conventional treatment which will include:
Hot pack for 15 minutes .
TENS for 10 minutes .
self stretching of hamstrings
Primary Outcome Measure Information:
Title
Sit and Reach Test
Description
Used for measurement of flexibility of the lower back and hamstring muscles.The reliability with ICC= 0.99 Baseline,6th visit,12th visit
Time Frame
12th day
Title
Straight Leg Raise Passive Knee Extension Test (PKE)
Description
Examine the joint range and its quality of movement; in particular, the 'end feel' of the joint.It has excellent test-retest reliability with ICC=0.94 and moderate validity= 0.57 to 0.63 Baseline,6th visit,12th visit
Time Frame
12 Day
Title
The Oswestry Disability Index (ODI)
Description
Tool used to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). The ODI score is recommended as a back pain-specific measure of disability. Reliability with ICC= 0.85 and validity=0.77 Baseline,6th visit,12th visit
Time Frame
12 Day
Secondary Outcome Measure Information:
Title
Numeric pain rating scale
Description
A scale for pain measurement, ranging from '0' representing no pain to '10' representing the worst or severe pain. The reliability with ICC= 0.64 to 0.86 Baseline,6th visit,12th visit
Time Frame
12th day
Title
Inclinometer
Description
It is an instrument used to measure range of motion (ROM) (36). The inter rater reliability with ICC= 0.80 Baseline,6th visit,12th visit
Time Frame
12th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low back pain for at least 2 months.
A passive SLR angle of 70° or less.
Both genders.
25-40 years age.
Pain > 3 on NPRS
Exclusion Criteria:
Any fracture of spine or lower limb.
No neurological signs.
Malignancy, infection, trauma or any bony deformity.
Surgery of spine or lower limb.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafaq Shahid, MSPT(OMPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral,Pakistan
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of ELDOA on Hamstring Tightness
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