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ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ELDOA exercises
Lumbar SNAGS and motor control exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Core stability, Disability, Low Back Pain, Stretching Exercise

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-30 Patients of both genders. Patients having chronic Low Back Pain ( >3 months duration) Patients with restricted range of motion (patients will be examined for active lumbar range of motion) Patients with lumbar straightening based on referral from orthopedic Exclusion Criteria: History of neurological condition of hip and lumbar region. Medical red flag history (tumor, metabolic diseases, rheumatoid arthritis, osteoporosis or Infection) Medical record of severe disabling chronic cardiovascular and pulmonary disease. Prescribed history of epidural steroidal injection for pain.

Sites / Locations

  • DHQRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

ELDOA exercises

Lumbar SNAGS and motor control exercises

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
The 11-point NPRS (intervals from 0-10) is used to quantify pain intensity; 0 represents no pain, and 10 represent the worst possible agony
Oswestry Disability Index
Questionnaire examines perceived level of disability in 10 everyday activities of daily living. Test-retest reliability has been shown to be high, a study by Fairbank et al recorded values ranging from = 0.83 to 0.99 that can vary over a given period of time. Each item consists of 6 statements. With Each item is scored on a 0---5 scale, and the maximum score is 50.
Inclinometer
Lumbar spine mobility will be assessed by inclinometer. It consists of a circular, fluid- filled disk with a bubble that indicates the number of degrees on the scale of protractor.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06049251
Brief Title
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises
Official Title
Effects of ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises on Pain, Function and Mobility in Patients With Chronic Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

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
Study will be a Randomized clinical trial to check the effects of ELDOA technique versus lumbar SNAGS with motor control exercises on pain, function and mobility in patients with chronic low back pain. Duration of study will be 8 months, non probability convenience sampling technique will be used, subject following eligibility criteria from District Headquarters Hospital Okara will be randomly allocated in two groups using computer random number generator. baseline assessment will be done. Group A participants will be given baseline treatment along with ELDOA exercises, Group B participants will be given baseline treatment along with Lumbar SNAGS and motor control exercises for 3 weeks. Assessment will be done by using Numeric Pain Rating Scale, Oswestry Disability Index and Inclinometer at baseline, at 3 weeks and a follow up will be taken at 6 weeks. 3 sessions per week will be given, data will be analyzed by using SPSS version 21.
Detailed Description
LBP is a significant global health problem, and its impact is still great. In 2019, there were 6972.5 (95% UI 6190.5 to 7860.5) age-standardized point prevalence estimates for LBP worldwide, with 568.4 million (95% UI 505.0 to 640.6 million) prevalent cases. The GBD research also revealed that LBP has a worldwide point prevalence of 9.4%, with men having a greater prevalence than women (8.7% vs. 10.1%). Back discomfort might arise as a result of mobility disorders, musculoskeletal sprains, incorrect spine positioning, or nucleus pulposus degeneration. There is huge literature regarding the management of low back pain and yet after the decades of research there are gaps in treatment options. The current study will compare the ELDOA technique to Lumbar SNAGS with motor control exercises. The current study is novel in a way that there is very limited evidence avialbale on ELDOA Technique and Motor Control Exercises. This study will provide vital insights into their efficacy and can help to guide clinical decision making for individuals with low back pain. Furthermore, this study can add to the expanding body of information regarding low back pain treatment and will help to improve patient outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Core stability, Disability, Low Back Pain, Stretching Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
ELDOA exercises
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Lumbar SNAGS and motor control exercises
Intervention Type
Other
Intervention Name(s)
ELDOA exercises
Intervention Description
The patients will be asked to sit down on a floor in upright position and keep their legs apart and knees semi-flexed, feet in outward and upward position, knees constantly pushing downwards, straight lower back, raise arms with palms facing upward, and chin should be pulled back. ELDOA stretch for L5-S1 level Patients will be asked to lay on floor and flatten and bring their legs up and straight with the support of wall, straight knees and keep distance between them, connect their toes, raise arm and externally rotate with wrist extension than press their heels and palms out. ELDOA exercises will be performed with 2 sets of 5 repetitions with 45 second hold and15 sec rest between each set once a day.
Intervention Type
Other
Intervention Name(s)
Lumbar SNAGS and motor control exercises
Intervention Description
The patient will be seated and his pelvis will be stabilized with belt at the level of the anterior superior iliac spine while the SNAGs are administered. The ulnar aspect of the therapist's hand will be placed over the spinous processes of the affected segment's superior vertebrae, for flexion glide and inferior vertebrae for extension glide respectively. A passive glide will be applied and kept up until the patient finished a full movement arc. The glides will be given for six repetitions for three sets every session. Glide can be given unilateral for other movements. Motor Control Exercises: Exercise training with 7sec Hold and 10 reps
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The 11-point NPRS (intervals from 0-10) is used to quantify pain intensity; 0 represents no pain, and 10 represent the worst possible agony
Time Frame
3rd Week
Title
Oswestry Disability Index
Description
Questionnaire examines perceived level of disability in 10 everyday activities of daily living. Test-retest reliability has been shown to be high, a study by Fairbank et al recorded values ranging from = 0.83 to 0.99 that can vary over a given period of time. Each item consists of 6 statements. With Each item is scored on a 0---5 scale, and the maximum score is 50.
Time Frame
3rd Week
Title
Inclinometer
Description
Lumbar spine mobility will be assessed by inclinometer. It consists of a circular, fluid- filled disk with a bubble that indicates the number of degrees on the scale of protractor.
Time Frame
3rd Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-30 Patients of both genders. Patients having chronic Low Back Pain ( >3 months duration) Patients with restricted range of motion (patients will be examined for active lumbar range of motion) Patients with lumbar straightening based on referral from orthopedic Exclusion Criteria: History of neurological condition of hip and lumbar region. Medical red flag history (tumor, metabolic diseases, rheumatoid arthritis, osteoporosis or Infection) Medical record of severe disabling chronic cardiovascular and pulmonary disease. Prescribed history of epidural steroidal injection for pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman
Organizational Affiliation
Riphah International University, Lahore, pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ
City
Okāra
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman
Phone
0320-7866611
Email
shakil.urrehman@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Anam Hamid

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34934626
Citation
Chen S, Chen M, Wu X, Lin S, Tao C, Cao H, Shao Z, Xiao G. Global, regional and national burden of low back pain 1990-2019: A systematic analysis of the Global Burden of Disease study 2019. J Orthop Translat. 2021 Sep 10;32:49-58. doi: 10.1016/j.jot.2021.07.005. eCollection 2022 Jan.
Results Reference
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PubMed Identifier
31511784
Citation
Ma K, Zhuang ZG, Wang L, Liu XG, Lu LJ, Yang XQ, Lu Y, Fu ZJ, Song T, Huang D, Liu H, Huang YQ, Peng BG, Liu YQ. The Chinese Association for the Study of Pain (CASP): Consensus on the Assessment and Management of Chronic Nonspecific Low Back Pain. Pain Res Manag. 2019 Aug 15;2019:8957847. doi: 10.1155/2019/8957847. eCollection 2019.
Results Reference
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Citation
3. Chitale N, Patil D, Phansopkar P. Efficacy of Integrated Neuromuscular Inhibition Technique Versus Mulligan Mobilization on Pain and Functional Disability in Subjects with Non-Specific Low Back Pain-A Research Protocol. Journal of Pharmaceutical Research International. 2021:99-104
Results Reference
background
PubMed Identifier
32894238
Citation
Shahzad M, Rafique N, Shakil-Ur-Rehman S, Ali Hussain S. Effects of ELDOA and post-facilitation stretching technique on pain and functional performance in patients with piriformis syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(6):983-988. doi: 10.3233/BMR-181290.
Results Reference
background
PubMed Identifier
30471967
Citation
Stuge B. Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review. Braz J Phys Ther. 2019 Mar-Apr;23(2):181-186. doi: 10.1016/j.bjpt.2018.11.006. Epub 2018 Nov 17.
Results Reference
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Citation
7. Salik S, Rani S, Hayat R, Manzoor S, Malik AU, Maqbool S. Comparison between Mulligan Sustained natural apophyseal glides (snags) VS McKenzie exercises in Chronic Mechanical Low back pain. Pakistan Journal of Medical & Health Sciences. 2022;16(10):141-.
Results Reference
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Citation
8. Shamshad M, Kanwal R, Butt R, Haider HMM. Effects of ELDOA technique versus McKenzie extension exercises on non-specific low back pain patients.: a randomized clinical trial. The Rehabilitation Journal. 2022;6(03):429-34.
Results Reference
background
PubMed Identifier
33777508
Citation
Bhat P V, Patel VD, Eapen C, Shenoy M, Milanese S. Myofascial release versus Mulligan sustained natural apophyseal glides' immediate and short-term effects on pain, function, and mobility in non-specific low back pain. PeerJ. 2021 Mar 15;9:e10706. doi: 10.7717/peerj.10706. eCollection 2021.
Results Reference
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PubMed Identifier
36823567
Citation
Ibrahim AA, Akindele MO, Ganiyu SO. Effectiveness of patient education plus motor control exercise versus patient education alone versus motor control exercise alone for rural community-dwelling adults with chronic low back pain: a randomised clinical trial. BMC Musculoskelet Disord. 2023 Feb 23;24(1):142. doi: 10.1186/s12891-022-06108-9.
Results Reference
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ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises

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