Lumbar RadiculopathyNCT06087107
Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy
A study testing High Intensity Spinal Decompression Exercises and Eldoa in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of high intensity spinal decompression exercises and Eldoa on pain, ROM and Disability in patients of lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- High Intensity Spinal Decompression Exercises and Eldoa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 25 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants pre-diagnosed with lumber radiculopathy
- Women and men between the age of 25 to 45 years
- Participants with chronic low back pain radiated to one or both legs
Who cannot join
- Diagnosed with Spinal tumour
- Diagnosed with Lumbar spine surgery
- Diagnosed with Lumbar spondylolisthesis
- Diagnosed with Fracture of lumbar spine
- Diagnosed with Ankylosing spondylitis
- Diagnosed with Pacemaker \& Taking blood thinner medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa On Pain, Range Of Motion And Disability In Patients Of Lumbar Radiculopathy
To compare the effects of high intensity spinal decompression exercises and Eldoa on pain, ROM and Disability in patients of lumbar radiculopathy.
Read the detailed description
In year 2020, a study conducted on the effect of eldoa alone and eldoa with core muscle strengthening to treat pain in patients with PIVD to determine the best treatment protocol between core muscle strengthening with and without eldoa to treat pain the numeric pain rating scale was used to measure pain. The study was done on 30 females randomly placed in two groups. The patients were treated for 3 days in a week on alternate days, for six consecutive weeks The eldoa technique was used segmentally on spine with different position as for l5-s1, patient flattens spine, curls back the toes curled back, inverses the ankles, internally rotates the hip, swings the arms up over the head while maintaining tension in same position as for l4-l5. Both reported decrease in pain intensity on NPRS at 6th week. So, results suggest that there was no significant difference between the effectiveness of techniques on reducing intensity of pain on NPRS.
In year 2021, a study conducted on effects of decompression and eldoa on pain and disability in lumbar disc protrusion. This study was done on 122 patients with the history of prolong sitting divided in two groups, one group was given decompression therapy and other group was treated with Eldoa which concluded that the pain could be significantly decreased while applying ELDOA for the patients with disc pathologies in musicians when assess pre and posttreatment. Likewise in this study, the quality of life of participants was significantly improved after the administration of ELDOA therapy.
In year 2022, RCT conducted on the effects of McKenzie extension exercise and ELDOA stretch in non-specific low back pain patients at railway general hospital, Rawalpindi and IRADA rehabilitation center. 48 female participants with the age range of 40-69 years and had chronic non-specific low back pain for more than 3 months were included in the study. Both groups were assessed at baseline score of ODI, BMI, NPRs after 2nd week and 4th week. According to this , McKenzie extension exercises significantly improved nonspecific low back pain and lumbar extension ROM.
In year 2022, a study conducted on effects of ELDOA Technique with Conservative Treatment on Pain Threshold of Active Trigger Points in Upper Trapezius and Levator Scpulae. She included 26 participants in her study and divided it into two groups. She measured pain, range of motion and disability after treatment. After analysis, results of her study showed that eldoa approach reduced discomfort, cervical ranges and neck impairment brought on by trigger points.
There is limited literature available regarding the effects of High intensity spinal decompression exercises and ELDOA therapy in patients with lumbar radiculopathy. Previous literature did not include the side bending and rotation component of range of motion and comparison between those two techniques. Therefore, in this study effects of ELDOA therapy will be compared with spinal decompression exercise to improve pain and range of motion and function in patients with lumbar radiculopathy and also include home plan after the session.
- Conditions
- Lumbar Radiculopathy
- Being tested
- High Intensity Spinal Decompression Exercises, Eldoa
- Keywords
- Radiculopathy, Decompression, Pain, Range of motion
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Spinal Decompression ExercisesOther
The duration of the intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 40 minutes with 8-10 repetitions of each exercise.
EldoaOther
The duration of the intervention will be 4 weeks, 3 sessions a week, and a total of 12 sessions will be given to the study participants. Each session will last for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Spinal Decompression Exercises | Experimental | Participants in this group will receive high intensity spinal decompression exercises Receives: Other: High Intensity Spinal Decompression Exercises |
| Eldoa | Active comparator | Participants in this group will receive Eldoa. Receives: Other: Eldoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain(NPRS)
Changes from the baseline 11-point NPRS is used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be valid and reliable with validity range from 0.86 to 0.95 and reliability r=0.96 and 0.95 with intraclass correlation coefficient of 0.95
Measured: 4th week
Range of motion spine (flexion)
Changes from baseline ROM range of motion of spinal flexion will be taken with the help of inclinometer
Measured: 4th week
Range of Motion Spine (Extension)
Changes from baseline ROM range of motion of spinal extension will be taken with the help of inclinometer
Measured: 4th week
Range of Motion Spine (Right side bending)
Changes from baseline ROM range of motion of spinal right side bending will be taken with the help of inclinometer
Measured: 4th week
Range of Motion Spine (left side bending)
Changes from baseline ROM range of motion of spinal left side bending will be taken with the help of inclinometer
Measured: 4th week
Range of Motion Spine (right side rotation)
Changes from baseline ROM range of motion of spinal right side rotation will be taken with the help of inclinometer
Measured: 4th week
Range of Motion Spine (left side rotation)
Changes from baseline ROM range of motion of spinal left side rotation will be taken with the help of inclinometer
Measured: 4th week
Disability: Oswestry disability index questionnaire (ODI)
Changes from baseline ODI.is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools interpretation of score are mentioned in the study.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start20 Oct 2023
- Primary completion30 Dec 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies 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
- Model description
- Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Amjad, MPhil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087107
- Sponsor's protocol ID
- REC/RCR&AHS/23/0160 Usman Ejaz
- Status last verified
- Mar 2024
- First submitted
- 11 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iversen T, Solberg TK, Wilsgaard T, Waterloo K, Brox JI, Ingebrigtsen T. Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study. BMC Musculoskelet Disord. 2015 Feb 7;16(1):17. doi: 10.1186/s12891-015-0474-9.
PubMed 25887469Ostelo RW. Physiotherapy management of sciatica. J Physiother. 2020 Apr;66(2):83-88. doi: 10.1016/j.jphys.2020.03.005. Epub 2020 Apr 11. No abstract available.
PubMed 32291226Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
PubMed 31788391Grimm BD, Blessinger BJ, Darden BV, Brigham CD, Kneisl JS, Laxer EB. Mimickers of lumbar radiculopathy. J Am Acad Orthop Surg. 2015 Jan;23(1):7-17. doi: 10.5435/JAAOS-23-01-7.
PubMed 25538126
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa On Pain, Range Of Motion And Disability In Patients Of Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT06087107
- Acronym / sponsor ID
- REC/RCR&AHS/23/0160 Usman Ejaz
- Conditions
- Lumbar Radiculopathy
- Keywords
- Radiculopathy, Decompression, Pain, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 17 Oct 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.
To compare the effects of high intensity spinal decompression exercises and Eldoa on pain, ROM and Disability in patients of lumbar radiculopathy.
Detailed description
In year 2020, a study conducted on the effect of eldoa alone and eldoa with core muscle strengthening to treat pain in patients with PIVD to determine the best treatment protocol between core muscle strengthening with and without eldoa to treat pain the numeric pain rating scale was used to measure pain. The study was done on 30 females randomly placed in two groups. The patients were treated for 3 days in a week on alternate days, for six consecutive weeks The eldoa technique was used segmentally on spine with different position as for l5-s1, patient flattens spine, curls back the toes curled back, inverses the ankles, internally rotates the hip, swings the arms up over the head while maintaining tension in same position as for l4-l5. Both reported decrease in pain intensity on NPRS at 6th week. So, results suggest that there was no significant difference between the effectiveness of techniques on reducing intensity of pain on NPRS.
In year 2021, a study conducted on effects of decompression and eldoa on pain and disability in lumbar disc protrusion. This study was done on 122 patients with the history of prolong sitting divided in two groups, one group was given decompression therapy and other group was treated with Eldoa which concluded that the pain could be significantly decreased while applying ELDOA for the patients with disc pathologies in musicians when assess pre and posttreatment. Likewise in this study, the quality of life of participants was significantly improved after the administration of ELDOA therapy.
In year 2022, RCT conducted on the effects of McKenzie extension exercise and ELDOA stretch in non-specific low back pain patients at railway general hospital, Rawalpindi and IRADA rehabilitation center. 48 female participants with the age range of 40-69 years and had chronic non-specific low back pain for more than 3 months were included in the study. Both groups were assessed at baseline score of ODI, BMI, NPRs after 2nd week and 4th week. According to this , McKenzie extension exercises significantly improved nonspecific low back pain and lumbar extension ROM.
In year 2022, a study conducted on effects of ELDOA Technique with Conservative Treatment on Pain Threshold of Active Trigger Points in Upper Trapezius and Levator Scpulae. She included 26 participants in her study and divided it into two groups. She measured pain, range of motion and disability after treatment. After analysis, results of her study showed that eldoa approach reduced discomfort, cervical ranges and neck impairment brought on by trigger points.
There is limited literature available regarding the effects of High intensity spinal decompression exercises and ELDOA therapy in patients with lumbar radiculopathy. Previous literature did not include the side bending and rotation component of range of motion and comparison between those two techniques. Therefore, in this study effects of ELDOA therapy will be compared with spinal decompression exercise to improve pain and range of motion and function in patients with lumbar radiculopathy and also include home plan after the session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
| Arm | Type | Receives |
|---|---|---|
| High Intensity Spinal Decompression Exercises | Experimental | Other: High Intensity Spinal Decompression ExercisesParticipants in this group will receive high intensity spinal decompression exercises |
| Eldoa | Active comparator | Other: EldoaParticipants in this group will receive Eldoa. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants pre-diagnosed with lumber radiculopathy
- Women and men between the age of 25 to 45 years
- Participants with chronic low back pain radiated to one or both legs
Key exclusion criteria (6 listed)
- Diagnosed with Spinal tumour
- Diagnosed with Lumbar spine surgery
- Diagnosed with Lumbar spondylolisthesis
- Diagnosed with Fracture of lumbar spine
- Diagnosed with Ankylosing spondylitis
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 |
|---|---|---|
| High Intensity Spinal Decompression ExercisesThe duration of the intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 40 minutes with 8-10 repetitions of each exercise. | Other | High Intensity Spinal Decompression Exercises |
| EldoaThe duration of the intervention will be 4 weeks, 3 sessions a week, and a total of 12 sessions will be given to the study participants. Each session will last for 40 minutes. | Other | Eldoa |
Primary outcome
Pain(NPRS)
Time frame: 4th week
Changes from the baseline 11-point NPRS is used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the 3 ratings or any single rating may be used to represent the patient's level of pain. Numeric pain scales have been shown to be valid and reliable with validity range from 0.86 to 0.95 and reliability r=0.96 and 0.95 with intraclass correlation coefficient of 0.95
Range of motion spine (flexion)
Time frame: 4th week
Changes from baseline ROM range of motion of spinal flexion will be taken with the help of inclinometer
Range of Motion Spine (Extension)
Time frame: 4th week
Changes from baseline ROM range of motion of spinal extension will be taken with the help of inclinometer
Range of Motion Spine (Right side bending)
Time frame: 4th week
Changes from baseline ROM range of motion of spinal right side bending will be taken with the help of inclinometer
Range of Motion Spine (left side bending)
Time frame: 4th week
Changes from baseline ROM range of motion of spinal left side bending will be taken with the help of inclinometer
Range of Motion Spine (right side rotation)
Time frame: 4th week
Changes from baseline ROM range of motion of spinal right side rotation will be taken with the help of inclinometer
Range of Motion Spine (left side rotation)
Time frame: 4th week
Changes from baseline ROM range of motion of spinal left side rotation will be taken with the help of inclinometer
Disability: Oswestry disability index questionnaire (ODI)
Time frame: 4th week
Changes from baseline ODI.is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools interpretation of score are mentioned in the study.
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 15 Mar 2024.
- Background: PubMed 25887469Iversen T, Solberg TK, Wilsgaard T, Waterloo K, Brox JI, Ingebrigtsen T. Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study. BMC Musculoskelet Disord. 2015 Feb 7;16(1):17. doi: 10.1186/s12891-015-0474-9.
- Background: PubMed 32291226Ostelo RW. Physiotherapy management of sciatica. J Physiother. 2020 Apr;66(2):83-88. doi: 10.1016/j.jphys.2020.03.005. Epub 2020 Apr 11. No abstract available.
- Background: PubMed 31788391Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
- Background: PubMed 25538126Grimm BD, Blessinger BJ, Darden BV, Brigham CD, Kneisl JS, Laxer EB. Mimickers of lumbar radiculopathy. J Am Acad Orthop Surg. 2015 Jan;23(1):7-17. doi: 10.5435/JAAOS-23-01-7.
- 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.
Faiza Amjad, MPhil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Spinal Decompression Exercises and Eldoa in people with Lumbar Radiculopathy, 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 3 inclusion and 6 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 15 Mar 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?
Pain(NPRS) (time frame: 4th week). The study lists 8 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 NCT06087107, which also lists 4 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 15 Mar 2024.