NCT04757441

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

February 2, 2021

Last Update Submit

May 1, 2021

Conditions

Keywords

ELDOALBPROMFlexibilityODI

Outcome Measures

Primary Outcomes (3)

  • 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

    12th day

  • 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

    12 Day

  • 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

    12 Day

Secondary Outcomes (2)

  • Numeric pain rating scale

    12th day

  • Inclinometer

    12th day

Study Arms (2)

Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire (ELDOA)

EXPERIMENTAL

Participants will receive conventional treatment along with ELDOA stretching exercises protocol at L5, S1.

Other: Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire

Group B: Conventional treatment

OTHER

Participants will receive only conventional treatment (Control)

Other: Group B: Conventional treatment

Interventions

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

Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire (ELDOA)

Participants will receive only conventional treatment which will include: * Hot pack for 15 minutes . * TENS for 10 minutes . * self stretching of hamstrings

Group B: Conventional treatment

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Low back pain for at least 2 months.
  • A passive SLR angle of 70° or less.
  • Both genders.
  • years age.
  • Pain \> 3 on NPRS

You may not qualify if:

  • Any fracture of spine or lower limb.
  • No neurological signs.
  • Malignancy, infection, trauma or any bony deformity.
  • Surgery of spine or lower limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral,Pakistan, 44000, Pakistan

Location

Related Publications (14)

  • Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.

    PMID: 14710506BACKGROUND
  • 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.

    PMID: 21665125BACKGROUND
  • 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)

    BACKGROUND
  • Tafazzoli F, Lamontagne M. Mechanical behaviour of hamstring muscles in low-back pain patients and control subjects. Clin Biomech (Bristol). 1996 Jan;11(1):16-24. doi: 10.1016/0268-0033(95)00038-0.

    PMID: 11415594BACKGROUND
  • 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.

    PMID: 26240711BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16550446BACKGROUND
  • 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.

    PMID: 28265144BACKGROUND
  • 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.

    PMID: 21982256BACKGROUND
  • 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.

    PMID: 8198197BACKGROUND
  • Hertling D, Kessler RM. Management of common musculoskeletal disorders: physical therapy principles and methods: Lippincott Williams & Wilkins; 2006

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 18796850BACKGROUND
  • 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.

    PMID: 26929476BACKGROUND

Study Officials

  • Shafaq Shahid, MSPT(OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 17, 2021

Study Start

August 13, 2020

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations