ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises

• ClinicalTrials.gov Identifier: NCT06049251
• Recruitment Status: Completed
• First Posted: September 22, 2023
• Last Update Posted: January 30, 2024
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: ELDOA exercises; Other: Lumbar SNAGS and motor control exercises	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: September 25, 2023
• Actual Primary Completion Date: January 10, 2024
• Actual Study Completion Date: January 15, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: ELDOA exercises; ELDOA exercises	Other: ELDOA exercises; 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.
Active Comparator: Lumbar SNAGS and motor control exercises; Lumbar SNAGS and motor control exercises	Other: Lumbar SNAGS and motor control exercises; 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

Outcome Measures

Primary Outcome Measures :

1. Numeric Pain Rating Scale [ Time Frame: 3rd Week ]
   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
2. Oswestry Disability Index [ Time Frame: 3rd Week ]
   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.
3. Inclinometer [ Time Frame: 3rd Week ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Pakistan

DHQ

Okāra, Punjab, Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

• Principal Investigator: Syed Shakil ur Rehman; Riphah International University, Lahore, pakistan

More Information

Publications:

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.

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.

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

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.

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.

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-.

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.

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.

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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT06049251
• Other Study ID Numbers: REC/RCR&AHS/23/0131 Anam Hamid
• First Posted: September 22, 2023
• Last Update Posted: January 30, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riphah International University:

Core stability; Disability; Low Back Pain; Stretching Exercise

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations