Lumbar Disc HerniationNCT04760210
Decompression With ELDOA on Lumbar Disc Protrusion Patient
A study testing Decompression Group and ELDOA in people with Lumbar Disc Herniation and Spinal Disk Injury, run by Aqua Medical Services (Pvt) Ltd at 1 site in Pakistan.
Trial summary
Decompression therapy is a result-oriented approach but it expensive and minimum availability in Pakistan. In physical therapy, we use different exercises to solve multiple spine problems. Some exercises used to treat orthogenic components such as mobilization, manipulation, SNAGS, and traction. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation, Spinal Disk Injury, Protrusion
- What is being tested?
- Decompression Group and ELDOA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 28 Feb 2021
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- MRI of the lumbar spine showing lumbar disc bulge
- Localized and radiating pain more than 5 on NPRS
Who cannot join
- Lumbar spondylolisthesis
- Spinal stenosis
- Fracture of the lumbar spine
- Spinal tumor
- Ankylosing spondylitis
- Patients taking blood thinner medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Effects of Decompression With ELDOA on Lumbar Disc Protrusion Patient
Decompression therapy is a result-oriented approach but it expensive and minimum availability in Pakistan. In physical therapy, we use different exercises to solve multiple spine problems. Some exercises used to treat orthogenic components such as mobilization, manipulation, SNAGS, and traction. Some exercises used to treat myogenic components such as muscle energy technique, neuromuscular reeducation, active isolated stretch, etc. Some exercises used to treat neurogenic components such as Neurodynamics, Active release technique, etc. As we know the fascia is an important component in our body most of the time the fascia restriction makes the patient condition verse. A researcher introduced the systems of exercise more the 35 years ago which works especially on the spine at every intervertebral level including costal and pelvic articulation. These exercises are called Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) or simply Longitudinal Osteo-Articular De-coaptation Stretching (LOADS). It can be described as a fascial stretch that's localized tension at the level of a specific spinal segment and create decompression. In which he combined improving the tone of the intrinsic muscles of the spine along with reinforcing the extrinsic muscles related to the spine aim the back and stretching the interlinking paraspinal muscles. ELDOA exercise is designed for every level of the spine from the base of the skull to the sacroiliac joint. In each ELDOA exercise, we create fascial tension above and below the joint or disc that one is trying to "open up" or decompress. The outcomes include; Release vertebral compression, improved blood circulation, Disc re-hydration, improve muscle tone, and awareness. One of my studies also proved that ELDOA Exercises improve the pain and functional level in spinal disc protrusion patients.
Read the detailed description
Low back pain is the common problem of our society, 80% of people experience back pain at some stage of their life. Low Back pain lifetime prevalence is 65% to 80% and It is estimated that 28% experience disabling low back pain sometime during their lives. Point prevalence ranged from 12% to 33%, the 1-year prevalence ranged from 22% to 65%, and lifetime prevalence ranged from 11% to 84%. Back pain peak prevalence age is 40-50, First episode of start in the '20s and recurrence rates between 39-71%. Women tend to be affected more in cervical spine problems than men and men tend to more affected in lumbar spine problems than women. The majority (80-90%) of low back disorders occur at the L4/5 and/or L5/S1. The occupational risk factor include driving (P<0.001), lifting, carrying, pulling, pushing, and twisting (P<0.001 for all variables) as well as nondriving vibrational exposure (P<0.001).
Maitland divides lumbar spine problems into two groups, in the first group the L4/5 and L5/S1 intervertebral discs are frequently a source of symptoms and the second group has postural, muscle balance, muscle weakness, muscles spasm degenerative changes, and mechanical movement disorders problems. The L5-S1 Segment is the most common site of problem in the spine because this level bears more weight, Center of gravity passes directly through this vertebra, transition L5 Mobile and S1 Stable, Large angle B/w L5 \& S1 and a great amount of movement.
The intervertebral disk makes up 1/3 of the total length of the vertebral column. The disc contains 85% to 90% of water, but the amount decreases up to 65% with age. The water-binding capacity of the disc decrease with age and degenerative changes begin to occur after 2nd decade of life. The Facet joint carries 20-25% axial body load but this may reach 70% with degeneration of the Disc. The most significant biochemical change to occur in disc degeneration is the loss of proteoglycan. This loss is responsible for a fall in the osmotic pressure of the disc matrix and therefore a loss of hydration. Loading may thus lead to inappropriate stress concentrations along the endplate or in the annulus.
CT Classification of Annular Tears There are five possible severities of the radial annular tear as seen on an axial CT image.
- The grade 0 is a normal disc, where no contrast material injected in the center of the disc has leaked from the confines of the nucleus pulposus.
- The grade 1 tear has leaked contrast material but only into the inner one-third of the annulus.
- In the grade 2 tear, the contrast has leaked from the nucleus into the outer two-thirds of the annulus.
- The grade 3 tear has leaked contrast completely through all three zones of the annulus.
- The grade 4 tear the contrast has spread circumferentially around the disc, often resembling a ship's anchor. Pathologically, this represents the merging of a full-thickness radial tear with a concentric annular tear.
- The grade 5 tear completely ruptured the outer layers of the disc and is leaking contrast material from the disc into the epidural space. This type of tear is thought to have the ability to induce a severe inflammatory reaction in the adjacent neural structures. In some patients, this inflammatory process is so severe that it causes painful chemical radiculopathy and sciatica without the presence of nerve root compression.
Low-back pain with leg pain may be caused by a herniated intervertebral disc exerting pressure on the nerve root. Most patients will respond to conservative treatment, but in carefully selected patients, a surgical discectomy may provide faster relief of symptoms. The Patient's history and physical examination along with MRI confirm the disc herniation diagnosis. In the case of spinal disc herniation, the management is Surgical and conservative. In surgery, we have percutaneous procedures such as chymopapain injections, Annuloplasty, Percutaneous disc decompression, and Endoscopic percutaneous discectomy and Open Surgery such as Laminectomy, Discectomy/Microdiscectomy, Artificial disc surgery, and Spinal fusion. The Conservative Management includes Oral Analgesic, Gentle traction, Spinal Decompression, Spinal Stabilization, Exercise, and Fascia Stretching (ELDOA).
- Conditions
- Lumbar Disc Herniation, Spinal Disk Injury, Protrusion
- Being tested
- Control Group, Decompression Group, ELDOA
- Keywords
- Lumbar Disc Protrusion, Spinal Decompression, Rehabilitation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Also called Group A
Treatment for this group is conventional physical therapy along with the bed rest.
Decompression GroupOther
Also called Group B
Treatment for this is conventional physical therapy along with the spinal decompression.
ELDOAOther
Also called Group C
Treatment for this is conventional physical therapy along with the ELDOA.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Pre-physiotherapy session:
1. Tens
2. Infrared/Moist Heat heat for 10 minutes at the low back region.
3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
6. Postural Education
7. Home Plan with lumbar Sacral Support
Bed rest after the controlled treatment is recommended for this group. Receives: Other: Control Group |
| Decompression | Active comparator | Pre-physiotherapy session:
1. Tens
2. Infrared/Moist Heat heat for 10 minutes at the low back region.
3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
6. Postural Education
7. Home Plan
Decompression therapy session after the controlled treatment is recommended for this group. Receives: Other: Decompression Group |
| ELDOA | Active comparator | Pre-physiotherapy session:
1. Tens
2. Infrared/Moist Heat heat for 10 minutes at low back region.
3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
6. Postural Education
7. Home Plan
Segmental Spinal ELDOA Exercise after the controlled treatment is recommended for this group. Receives: Other: ELDOA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The scale of pain. The patient will be asked to report pain on a 1-10 numbering scale. 1 means minimum pain and 10 means extreme pain.
Measured: Up to 3 weeks
Oswestry disability index
The scale of disability. The patient will be asked the referenced questions and the assessor will tick the answers. The maximum score of the Oswestry disability index is 100 percent which means complete disability whereas the minimum score is 0 percent which means no disability at all.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aqua Medical Services (Pvt) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd
- Investigators
- Abdul Ghafoor Sajjad, MSPT, Principal investigator, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760210
- Sponsor's protocol ID
- REC 00492 Abdul Ghafoor
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Archaeos Projects. (1999). Preliminary Site Report of the Oriental Institute of the University of Vienna and Archaeos: Excavation Project at Tell Arbid, Sector D Retrieved 04/09/2004, 2004, from http://www.archaeos.org/html/repor2js.htm
Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
PubMed 15834339Breslau, A. M., & Gabe, M. (1962). Ergebnisse der Polysaccharidhistochemie, Microorganismen, Invertebraten : mit 25. Stuttgart: Fischer.
Delauche-Cavallier MC, Budet C, Laredo JD, Debie B, Wybier M, Dorfmann H, Ballner I. Lumbar disc herniation. Computed tomography scan changes after conservative treatment of nerve root compression. Spine (Phila Pa 1976). 1992 Aug;17(8):927-33.
PubMed 1387974Dvorak J, Gauchat MH, Valach L. The outcome of surgery for lumbar disc herniation. I. A 4-17 years' follow-up with emphasis on somatic aspects. Spine (Phila Pa 1976). 1988 Dec;13(12):1418-22. doi: 10.1097/00007632-198812000-00015.
PubMed 3212575Frymoyer JW, Pope MH, Costanza MC, Rosen JC, Goggin JE, Wilder DG. Epidemiologic studies of low-back pain. Spine (Phila Pa 1976). 1980 Sep-Oct;5(5):419-23. doi: 10.1097/00007632-198009000-00005.
PubMed 6450452Hammer, W. I. (2007). Functional soft-tissue examination and treatment by manual methods: Jones & Bartlett Learning.
Khan, A. G. S. G. A., & Khan, A. (2016). Fascia Stretching Improve the Pain and Functional Level in Disc Protrusion Patients. Journal of Riphah College of Rehabilitaion Sciences, 4(1), 7-10.
Krause M, Refshauge KM, Dessen M, Boland R. Lumbar spine traction: evaluation of effects and recommended application for treatment. Man Ther. 2000 May;5(2):72-81. doi: 10.1054/math.2000.0235.
PubMed 10903582Saal JA, Saal JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy. An outcome study. Spine (Phila Pa 1976). 1989 Apr;14(4):431-7. doi: 10.1097/00007632-198904000-00018.
PubMed 2718047van der Windt DA, Simons E, Riphagen II, Ammendolia C, Verhagen AP, Laslett M, Deville W, Deyo RA, Bouter LM, de Vet HC, Aertgeerts B. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007431. doi: 10.1002/14651858.CD007431.pub2.
PubMed 20166095Weber H. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine (Phila Pa 1976). 1983 Mar;8(2):131-40.
PubMed 6857385
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Decompression With ELDOA on Lumbar Disc Protrusion Patient
- ClinicalTrials.gov ID
- NCT04760210
- Acronym / sponsor ID
- REC 00492 Abdul Ghafoor
- Conditions
- Lumbar Disc Herniation, Spinal Disk Injury, Protrusion
- Keywords
- Lumbar Disc Protrusion, Spinal Decompression, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Aqua Medical Services (Pvt) LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 18 Feb 2021 (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.
Decompression therapy is a result-oriented approach but it expensive and minimum availability in Pakistan. In physical therapy, we use different exercises to solve multiple spine problems. Some exercises used to treat orthogenic components such as mobilization, manipulation, SNAGS, and traction. Some exercises used to treat myogenic components such as muscle energy technique, neuromuscular reeducation, active isolated stretch, etc. Some exercises used to treat neurogenic components such as Neurodynamics, Active release technique, etc. As we know the fascia is an important component in our body most of the time the fascia restriction makes the patient condition verse. A researcher introduced the systems of exercise more the 35 years ago which works especially on the spine at every intervertebral level including costal and pelvic articulation. These exercises are called Elongation Longitudinaux Avec Decoaption Osteo-Articulaire (ELDOA) or simply Longitudinal Osteo-Articular De-coaptation Stretching (LOADS). It can be described as a fascial stretch that's localized tension at the level of a specific spinal segment and create decompression. In which he combined improving the tone of the intrinsic muscles of the spine along with reinforcing the extrinsic muscles related to the spine aim the back and stretching the interlinking paraspinal muscles. ELDOA exercise is designed for every level of the spine from the base of the skull to the sacroiliac joint. In each ELDOA exercise, we create fascial tension above and below the joint or disc that one is trying to "open up" or decompress. The outcomes include; Release vertebral compression, improved blood circulation, Disc re-hydration, improve muscle tone, and awareness. One of my studies also proved that ELDOA Exercises improve the pain and functional level in spinal disc protrusion patients.
Detailed description
Low back pain is the common problem of our society, 80% of people experience back pain at some stage of their life. Low Back pain lifetime prevalence is 65% to 80% and It is estimated that 28% experience disabling low back pain sometime during their lives. Point prevalence ranged from 12% to 33%, the 1-year prevalence ranged from 22% to 65%, and lifetime prevalence ranged from 11% to 84%. Back pain peak prevalence age is 40-50, First episode of start in the '20s and recurrence rates between 39-71%. Women tend to be affected more in cervical spine problems than men and men tend to more affected in lumbar spine problems than women. The majority (80-90%) of low back disorders occur at the L4/5 and/or L5/S1. The occupational risk factor include driving (P<0.001), lifting, carrying, pulling, pushing, and twisting (P<0.001 for all variables) as well as nondriving vibrational exposure (P<0.001).
Maitland divides lumbar spine problems into two groups, in the first group the L4/5 and L5/S1 intervertebral discs are frequently a source of symptoms and the second group has postural, muscle balance, muscle weakness, muscles spasm degenerative changes, and mechanical movement disorders problems. The L5-S1 Segment is the most common site of problem in the spine because this level bears more weight, Center of gravity passes directly through this vertebra, transition L5 Mobile and S1 Stable, Large angle B/w L5 \& S1 and a great amount of movement.
The intervertebral disk makes up 1/3 of the total length of the vertebral column. The disc contains 85% to 90% of water, but the amount decreases up to 65% with age. The water-binding capacity of the disc decrease with age and degenerative changes begin to occur after 2nd decade of life. The Facet joint carries 20-25% axial body load but this may reach 70% with degeneration of the Disc. The most significant biochemical change to occur in disc degeneration is the loss of proteoglycan. This loss is responsible for a fall in the osmotic pressure of the disc matrix and therefore a loss of hydration. Loading may thus lead to inappropriate stress concentrations along the endplate or in the annulus.
CT Classification of Annular Tears There are five possible severities of the radial annular tear as seen on an axial CT image.
- The grade 0 is a normal disc, where no contrast material injected in the center of the disc has leaked from the confines of the nucleus pulposus.
- The grade 1 tear has leaked contrast material but only into the inner one-third of the annulus.
- In the grade 2 tear, the contrast has leaked from the nucleus into the outer two-thirds of the annulus.
- The grade 3 tear has leaked contrast completely through all three zones of the annulus.
- The grade 4 tear the contrast has spread circumferentially around the disc, often resembling a ship's anchor. Pathologically, this represents the merging of a full-thickness radial tear with a concentric annular tear.
- The grade 5 tear completely ruptured the outer layers of the disc and is leaking contrast material from the disc into the epidural space. This type of tear is thought to have the ability to induce a severe inflammatory reaction in the adjacent neural structures. In some patients, this inflammatory process is so severe that it causes painful chemical radiculopathy and sciatica without the presence of nerve root compression.
Low-back pain with leg pain may be caused by a herniated intervertebral disc exerting pressure on the nerve root. Most patients will respond to conservative treatment, but in carefully selected patients, a surgical discectomy may provide faster relief of symptoms. The Patient's history and physical examination along with MRI confirm the disc herniation diagnosis. In the case of spinal disc herniation, the management is Surgical and conservative. In surgery, we have percutaneous procedures such as chymopapain injections, Annuloplasty, Percutaneous disc decompression, and Endoscopic percutaneous discectomy and Open Surgery such as Laminectomy, Discectomy/Microdiscectomy, Artificial disc surgery, and Spinal fusion. The Conservative Management includes Oral Analgesic, Gentle traction, Spinal Decompression, Spinal Stabilization, Exercise, and Fascia Stretching (ELDOA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupPre-physiotherapy session: 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at the low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan with lumbar Sacral Support Bed rest after the controlled treatment is recommended for this group. |
| Decompression | Active comparator | Other: Decompression GroupPre-physiotherapy session: 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at the low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan Decompression therapy session after the controlled treatment is recommended for this group. |
| ELDOA | Active comparator | Other: ELDOAPre-physiotherapy session: 1. Tens 2. Infrared/Moist Heat heat for 10 minutes at low back region. 3. Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps 4. Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps 5. Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps 6. Postural Education 7. Home Plan Segmental Spinal ELDOA Exercise after the controlled treatment is recommended for this group. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- MRI of the lumbar spine showing lumbar disc bulge
- Localized and radiating pain more than 5 on NPRS
Key exclusion criteria (6 listed)
- Lumbar spondylolisthesis
- Spinal stenosis
- Fracture of the lumbar spine
- Spinal tumor
- 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 |
|---|---|---|
| Control GroupAlso: Group ATreatment for this group is conventional physical therapy along with the bed rest. | Other | Control Group |
| Decompression GroupAlso: Group BTreatment for this is conventional physical therapy along with the spinal decompression. | Other | Decompression |
| ELDOAAlso: Group CTreatment for this is conventional physical therapy along with the ELDOA. | Other | ELDOA |
Primary outcome
Numeric Pain Rating Scale
Time frame: Up to 3 weeks
The scale of pain. The patient will be asked to report pain on a 1-10 numbering scale. 1 means minimum pain and 10 means extreme pain.
Oswestry disability index
Time frame: Up to 3 weeks
The scale of disability. The patient will be asked the referenced questions and the assessor will tick the answers. The maximum score of the Oswestry disability index is 100 percent which means complete disability whereas the minimum score is 0 percent which means no disability at all.
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 5 Sep 2021.
- BackgroundArchaeos Projects. (1999). Preliminary Site Report of the Oriental Institute of the University of Vienna and Archaeos: Excavation Project at Tell Arbid, Sector D Retrieved 04/09/2004, 2004, from http://www.archaeos.org/html/repor2js.htm
- Background: PubMed 15834339Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
- BackgroundBreslau, A. M., & Gabe, M. (1962). Ergebnisse der Polysaccharidhistochemie, Microorganismen, Invertebraten : mit 25. Stuttgart: Fischer.
- Background: PubMed 1387974Delauche-Cavallier MC, Budet C, Laredo JD, Debie B, Wybier M, Dorfmann H, Ballner I. Lumbar disc herniation. Computed tomography scan changes after conservative treatment of nerve root compression. Spine (Phila Pa 1976). 1992 Aug;17(8):927-33.
- Background: PubMed 3212575Dvorak J, Gauchat MH, Valach L. The outcome of surgery for lumbar disc herniation. I. A 4-17 years' follow-up with emphasis on somatic aspects. Spine (Phila Pa 1976). 1988 Dec;13(12):1418-22. doi: 10.1097/00007632-198812000-00015.
- Background: PubMed 6450452Frymoyer JW, Pope MH, Costanza MC, Rosen JC, Goggin JE, Wilder DG. Epidemiologic studies of low-back pain. Spine (Phila Pa 1976). 1980 Sep-Oct;5(5):419-23. doi: 10.1097/00007632-198009000-00005.
- BackgroundHammer, W. I. (2007). Functional soft-tissue examination and treatment by manual methods: Jones & Bartlett Learning.
- BackgroundKhan, A. G. S. G. A., & Khan, A. (2016). Fascia Stretching Improve the Pain and Functional Level in Disc Protrusion Patients. Journal of Riphah College of Rehabilitaion Sciences, 4(1), 7-10.
- Background: PubMed 10903582Krause M, Refshauge KM, Dessen M, Boland R. Lumbar spine traction: evaluation of effects and recommended application for treatment. Man Ther. 2000 May;5(2):72-81. doi: 10.1054/math.2000.0235.
- Background: PubMed 2718047Saal JA, Saal JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy. An outcome study. Spine (Phila Pa 1976). 1989 Apr;14(4):431-7. doi: 10.1097/00007632-198904000-00018.
- Background: PubMed 20166095van der Windt DA, Simons E, Riphagen II, Ammendolia C, Verhagen AP, Laslett M, Deville W, Deyo RA, Bouter LM, de Vet HC, Aertgeerts B. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007431. doi: 10.1002/14651858.CD007431.pub2.
- Background: PubMed 6857385Weber H. Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine (Phila Pa 1976). 1983 Mar;8(2):131-40.
- 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.
Abdul Ghafoor Sajjad, MSPT principal investigator
Shifa Tameer-e-Millat 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 Decompression Group and ELDOA in people with Lumbar Disc Herniation and Spinal Disk Injury, run by Aqua Medical Services (Pvt) Ltd 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 2 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 5 Sep 2021. 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: Up to 3 weeks). The study lists 2 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 NCT04760210, which also lists 12 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 5 Sep 2021.