NCT06049251

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable low-back-pain

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

First Submitted

Initial submission to the registry

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

September 15, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

Core stabilityDisabilityLow Back PainStretching Exercise

Outcome Measures

Primary Outcomes (3)

  • 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

    3rd Week

  • 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.

    3rd Week

  • 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.

    3rd Week

Study Arms (2)

ELDOA exercises

EXPERIMENTAL

ELDOA exercises

Other: ELDOA exercises

Lumbar SNAGS and motor control exercises

ACTIVE COMPARATOR

Lumbar SNAGS and motor control exercises

Other: Lumbar SNAGS and motor control exercises

Interventions

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.

ELDOA 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

Lumbar SNAGS and motor control exercises

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ

Okāra, Punjab Province, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 34934626BACKGROUND
  • 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.

    PMID: 31511784BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 32894238BACKGROUND
  • 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.

    PMID: 30471967BACKGROUND
  • 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-.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 33777508BACKGROUND
  • 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.

    PMID: 36823567BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil ur Rehman

    Riphah International University, Lahore, pakistan

    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

September 15, 2023

First Posted

September 22, 2023

Study Start

September 25, 2023

Primary Completion

January 10, 2024

Study Completion

January 15, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations