- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757441
Effects of ELDOA on Hamstring Tightness
Effects of ELDOA on Hamstring Tightness in Individuals With Non-Specific Low Back Pain.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fedral,Pakistan
-
Islamabad, Fedral,Pakistan, Pakistan, 44000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire (ELDOA)
Participants will receive conventional treatment along with ELDOA stretching exercises protocol at L5, S1.
|
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:
|
|
Other: Group B: Conventional treatment
Participants will receive only conventional treatment (Control)
|
Participants will receive only conventional treatment which will include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sit and Reach Test
Time Frame: 12th day
|
Used for measurement of flexibility of the lower back and hamstring muscles.The reliability with ICC= 0.99 Baseline,6th visit,12th visit
|
12th day
|
|
Straight Leg Raise Passive Knee Extension Test (PKE)
Time Frame: 12 Day
|
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
|
12 Day
|
|
The Oswestry Disability Index (ODI)
Time Frame: 12 Day
|
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
|
12 Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 12th day
|
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
|
12th day
|
|
Inclinometer
Time Frame: 12th day
|
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
|
12th day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
- Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
- Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
- Jonhagen S, Nemeth G, Eriksson E. Hamstring injuries in sprinters. The role of concentric and eccentric hamstring muscle strength and flexibility. Am J Sports Med. 1994 Mar-Apr;22(2):262-6. doi: 10.1177/036354659402200218.
- Yildirim MS, Ozyurek S, Tosun O, Uzer S, Gelecek N. Comparison of effects of static, proprioceptive neuromuscular facilitation and Mulligan stretching on hip flexion range of motion: a randomized controlled trial. Biol Sport. 2016 Mar;33(1):89-94. doi: 10.5604/20831862.1194126. Epub 2016 Feb 8.
- Baharam NS, Hisham MY, Mohan V, Mohamad N. EFFECT OF STATIC STRETCHING ON MUSCLE ACTIVATION DURING SIT TO STAND AMONG LOW BACK PAIN POPULATION. Jurnal Teknologi. 2016;78(6-8)
- Tafazzoli F, Lamontagne M. Mechanical behaviour of hamstring muscles in low-back pain patients and control subjects. Clin Biomech (Bristol, Avon). 1996 Jan;11(1):16-24. doi: 10.1016/0268-0033(95)00038-0.
- Seif HE, Alenazi A, Hassan SM, Kachanathu SJ, Hafez AR. The Effect of Stretching Hamstring, Gastrocnemius, Iliopsoas and Back Muscles on Pain and Functional Activities in Patients with Chronic Low Back Pain: A Randomized Clinical Trial. Open Journal of Therapy and Rehabilitation. 2015;3(04):139.
- Burton AK, Balague F, Cardon G, Eriksen HR, Henrotin Y, Lahad A, Leclerc A, Muller G, van der Beek AJ; COST B13 Working Group on Guidelines for Prevention in Low Back Pain. Chapter 2. European guidelines for prevention in low back pain : November 2004. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S136-68. doi: 10.1007/s00586-006-1070-3. No abstract available.
- Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
- Hertling D, Kessler RM. Management of common musculoskeletal disorders: physical therapy principles and methods: Lippincott Williams & Wilkins; 2006
- Na'ima AL, Sari GM, Utomo DN, editors. Combination effect of core stability exercise and contract relax exercise on hamstring flexibility. Journal of Physics: Conference Series; 2019: IOP Publishing.
- Worrell TW, Perrin DH, Gansneder BM, Gieck JH. Comparison of isokinetic strength and flexibility measures between hamstring injured and noninjured athletes. J Orthop Sports Phys Ther. 1991;13(3):118-25. doi: 10.2519/jospt.1991.13.3.118.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00763 Sana Rasool
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-specific Low Back Pain
-
Lincoln University CollegeCairo University; Taif UniversityNot yet recruitingNon Specific Low Back Pain
-
Riphah International UniversityCompletedNon Specific Low Back PainPakistan
-
Laval UniversityMedTeq; Corset Saint-FrancisRecruitingNon-specific Low Back PainCanada
-
Bahçeşehir UniversityNot yet recruitingNon-specific Low Back PainTurkey (Türkiye)
-
Bahçeşehir UniversityNot yet recruitingChronic Non-specific Low Back PainTurkey (Türkiye)
-
Kirsehir Ahi Evran UniversitesiRecruitingEffects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back PainChronic Non-Specific Low Back PainTurkey (Türkiye)
-
University of HailNot yet recruitingNon Specific Chronic Low Back PainSaudi Arabia
-
Maheen RaufRecruitingNon-specific Chronic Low Back PainPakistan
-
University Hospital, MontpellierNot yet recruitingNon-specific Low Back Pain (NSLBP)
-
Ehab Mohamed Kamel AhmedThe Scientific Research Deanship, University of Ha'ilNot yet recruitingNon-specific Low Back Pain (NSLBP)Saudi Arabia
Clinical Trials on Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire
-
Aqua Medical Services (Pvt) LtdCompletedLumbar Disc HerniationPakistan
-
Riphah International UniversityCompletedKnee OsteoarthritisPakistan
-
Superior UniversityActive, not recruiting
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage 4S Neuroblastoma | Ganglioneuroblastoma | Stage 2A Neuroblastoma | Stage 2B Neuroblastoma | Stage 3 Neuroblastoma | Stage 4 Neuroblastoma | Stage 1 Neuroblastoma | Stage 2 NeuroblastomaUnited States, Canada, Australia, New Zealand