Low Back PainNCT06049251
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises
A study testing ELDOA exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- ELDOA exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- ELDOA exercises, Lumbar SNAGS and motor control exercises
- Keywords
- Core stability, Disability, Low Back Pain, Stretching Exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELDOA exercisesOther
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.
Lumbar SNAGS and motor control exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| ELDOA exercises | Experimental | ELDOA exercises Receives: Other: ELDOA exercises |
| Lumbar SNAGS and motor control exercises | Active comparator | Lumbar SNAGS and motor control exercises Receives: Other: Lumbar SNAGS and motor control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 3rd Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start25 Sep 2023
- Primary completion10 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, Principal investigator, Riphah International University, Lahore, pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049251
- Sponsor's protocol ID
- REC/RCR&AHS/23/0131 Anam Hamid
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34934626Ma 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.
PubMed 315117843. 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.
PubMed 32894238Stuge 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.
PubMed 304719677. 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.
PubMed 33777508Ibrahim 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.
PubMed 36823567
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06049251
- Acronym / sponsor ID
- REC/RCR&AHS/23/0131 Anam Hamid
- Conditions
- Low Back Pain
- Keywords
- Core stability, Disability, Low Back Pain, Stretching Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELDOA exercises | Experimental | Other: ELDOA exercisesELDOA exercises |
| Lumbar SNAGS and motor control exercises | Active comparator | Other: Lumbar SNAGS and motor control exercisesLumbar SNAGS and motor control exercises |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELDOA exercisesThe 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. | Other | ELDOA exercises |
| Lumbar SNAGS and motor control exercisesThe 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 | Other | Lumbar SNAGS and motor control exercises |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 34934626Chen 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.
- Background: PubMed 31511784Ma 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.
- Background3. 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: PubMed 32894238Shahzad 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.
- Background: PubMed 30471967Stuge 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.
- Background7. 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-.
- Background8. 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: PubMed 33777508Bhat 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.
- Background: PubMed 36823567Ibrahim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Shakil ur Rehman principal investigator
Riphah International University, Lahore, pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELDOA exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 3rd Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049251, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.