Lumbar RadiculopathyNCT05953727
Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients
A study testing Low level laser therapy with proprioceptive stimulation and Low level laser therapy without proprioceptive stimulation in people with Lumbar Radiculopathy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The aim of this study is to evaluate the effects of low level laser therapy with and without proprioceptive stimulation on somatosensation, pain and gait parameters in patients with discogenic lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Low level laser therapy with proprioceptive stimulation and Low level laser therapy without proprioceptive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesPakistan
- Study dates
- 11 Nov 2022to 1 Oct 2023
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45-70years(27)
- Both male and female patients
- Patients with acute Low Back Pain and unilateral Discogenic Lumbar Radiculopathy with disc bulge confirmed on MRI
- Pain intensity score is 4 or more on the numeric pain rating scale (NPRS)
- Radiating leg pain symptoms for less than 4 weeks
- Numbness and paresthesia in the affected area
- Patients with moderate to severe score (21%-60%) in ODI
Who cannot join
- Non willing patients
- Patients with severely cognitive disorders
- History of low back pain for more than 4 weeks
- History of any systemic disease such as Stroke, Multiple Sclerosis, Myopathies, Heart Failure etc
- Botulinum toxin injections to any lower extremity muscle in the last 3 months
- Malignancy
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Agile Rehabilitation Complex
Bahawalpur, Punjab Province, 63100
Muhammad Hafeez, 03212319576, drhafeezarain@gmail.com
Arslan Saeed, DPT
- Recruiting
Bahawal Victoria Hospital
Bahawalpur, Punjab Province, 63100
Muhammad Irshad, 03336352593
Arslan Saeed, DPT
About this study
Official title: Effects of Low Level Laser Therapy With and Without Proprioceptive Stimulation on Somatosensation, Pain And Gait Parameters in Patients With Discogenic Lumbar Radiculopathy
The aim of this study is to evaluate the effects of low level laser therapy with and without proprioceptive stimulation on somatosensation, pain and gait parameters in patients with discogenic lumbar radiculopathy. The randomized central trial will recruit patients according to convenience sampling into two intervention groups randomly. One group will receive low level laser therapy and proprioceptive stimulation and other group will receive low level laser therapy alone. Heating packs will be given to both groups.
Read the detailed description
Lumbar disc prolapse occurs when disc material, that is, nucleus pulposus or annulus fibrosis comes out of the intervertebral disc space. The ruptured nucleus interacts with the nearby surrounding nerves, resulting in their compression that in turn causes severe radicular pain. Lumbar disc prolapse is considered as a hallmark of low back pain (LBP). Typically, the pain is distributed bilaterally at the posterior beltline with a sharp, shooting pain running down to the low back, buttocks, and down the thigh along with numbness or tingling sensations. One of the major risk factors for low back pain is lumbar disc prolapse. The prevalence of disc prolapse in lumbar region is 90% (L4-L5 or L5-S1). Low back pain due to disc prolapse is generally self-limiting and of shorter duration
A double blind randomized controlled trial was conducted in 2022 by Ishaq et al. on 110 patients to determine the effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy and correlation among pain intensity, functional disability, and lumbar range of motion (LROM). The outcomes of the treatment were measured on the first day and then after 18 sessions from each patient's pain intensity, functional disability, L-ROM, and straight leg raise by using visual analogue scale, Oswestry disability index, dual inclinometer, and straight leg raise tests. Experimental group of 55 patients was treated with LLLT and conventional physical therapy while the control group of 55 patients was treated with conventional physical therapy alone. They concluded that LLLT is an efficient adjunct therapy to conventional physical therapy in patients of discogenic lumbar radiculopathy
In the reviewed literature, there seems to be a lack in establishing the effects of low-level laser therapy when combined with proprioceptive stimulation. Discogenic lumbar radiculopathy is very common due to an increased workload, increased number of road traffic accidents, poor postures and socioeconomic status, deficient medical or rehab services, and so on. Thus, there is need to conduct a research to determine the effects of low level laser therapy when combined with proprioceptive stimulation in improving patient's functional status, pain and gait issues.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Low level laser therapy with proprioceptive stimulation, Low level laser therapy without proprioceptive stimulation
- Keywords
- Discogenic Lumbar Radiculopathy, Gait Parameters, Low-Level Laser Therapy, Numeric pain rating scale
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapy with proprioceptive stimulationOther
Also called Heating packs
10 minutes of low level laser therapy and 10-15 minutes of proprioceptive stimulation and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.
Low level laser therapy without proprioceptive stimulationOther
Also called Heating packs
10 minutes of low level laser therapy and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy with proprioceptive stimulation | Experimental | Patients will be treated with low level laser therapy and proprioceptive stimulation will also be given. Receives: Other: Low level laser therapy with proprioceptive stimulation |
| Low level laser therapy without proprioceptive stimulation | Active comparator | Patients will be treated with low level laser therapy only. Receives: Other: Low level laser therapy without proprioceptive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nottingham Sensory Assessment
Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.
Measured: 6 weeks
NPRS
It is a common pain screening tool use to assess the severity of pain at moment time. It is '0-10' scale where '0' means 'no pain' and '10' means 'worst pain imaginable'.
Measured: 6 weeks
Step length
The distance measured in centimeters between the point of initial contact of one foot and the point of initial contact of the opposite foot is referred to as the step length.
Measured: 6 weeks
Stride Length
The distance covered in centimeters with two consecutive steps, one with each foot.
Measured: 6 weeks
Walking Cadence
Number of steps taken by an individual in one minute
Measured: 6 weeks
Secondary outcomes (1)
6 Minute Walk Test (6MWT)
This is a sub-maximal exercise test used to assess aerobic capacity and endurance. Distance covered over a time of 6 minutes is used to compare changes in performance capacity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start11 Nov 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953727
- Sponsor's protocol ID
- REC/RCR & AHS/23/0220
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
PubMed 24239490Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.
PubMed 24768732Parker SL, Xu R, McGirt MJ, Witham TF, Long DM, Bydon A. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. J Neurosurg Spine. 2010 Feb;12(2):178-82. doi: 10.3171/2009.9.SPINE09410.
PubMed 20121353Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
PubMed 19204216Ahmed I, Bandpei MAM, Gilani SA, Ahmad A, Zaidi F. Effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy: A Double-Blind Randomized Controlled Trial. J Healthc Eng. 2022 Feb 27;2022:6437523. doi: 10.1155/2022/6437523. eCollection 2022.
PubMed 35265302Benditz A, Loher M, Boluki D, Grifka J, Vollner F, Renkawitz T, Maderbacher G, Gotz J. Positive medium-term influence of multimodal pain management on socioeconomic factors and health care utilization in patients with lumbar radiculopathy: a prospective study. J Pain Res. 2017 Feb 14;10:389-395. doi: 10.2147/JPR.S128090. eCollection 2017.
PubMed 28243143National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/
PubMed 27929617
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Level Laser Therapy With and Without Proprioceptive Stimulation on Somatosensation, Pain And Gait Parameters in Patients With Discogenic Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT05953727
- Acronym / sponsor ID
- REC/RCR & AHS/23/0220
- Conditions
- Lumbar Radiculopathy
- Keywords
- Discogenic Lumbar Radiculopathy, Gait Parameters, Low-Level Laser Therapy, Numeric pain rating scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 20 Jul 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.
The aim of this study is to evaluate the effects of low level laser therapy with and without proprioceptive stimulation on somatosensation, pain and gait parameters in patients with discogenic lumbar radiculopathy. The randomized central trial will recruit patients according to convenience sampling into two intervention groups randomly. One group will receive low level laser therapy and proprioceptive stimulation and other group will receive low level laser therapy alone. Heating packs will be given to both groups.
Detailed description
Lumbar disc prolapse occurs when disc material, that is, nucleus pulposus or annulus fibrosis comes out of the intervertebral disc space. The ruptured nucleus interacts with the nearby surrounding nerves, resulting in their compression that in turn causes severe radicular pain. Lumbar disc prolapse is considered as a hallmark of low back pain (LBP). Typically, the pain is distributed bilaterally at the posterior beltline with a sharp, shooting pain running down to the low back, buttocks, and down the thigh along with numbness or tingling sensations. One of the major risk factors for low back pain is lumbar disc prolapse. The prevalence of disc prolapse in lumbar region is 90% (L4-L5 or L5-S1). Low back pain due to disc prolapse is generally self-limiting and of shorter duration
A double blind randomized controlled trial was conducted in 2022 by Ishaq et al. on 110 patients to determine the effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy and correlation among pain intensity, functional disability, and lumbar range of motion (LROM). The outcomes of the treatment were measured on the first day and then after 18 sessions from each patient's pain intensity, functional disability, L-ROM, and straight leg raise by using visual analogue scale, Oswestry disability index, dual inclinometer, and straight leg raise tests. Experimental group of 55 patients was treated with LLLT and conventional physical therapy while the control group of 55 patients was treated with conventional physical therapy alone. They concluded that LLLT is an efficient adjunct therapy to conventional physical therapy in patients of discogenic lumbar radiculopathy
In the reviewed literature, there seems to be a lack in establishing the effects of low-level laser therapy when combined with proprioceptive stimulation. Discogenic lumbar radiculopathy is very common due to an increased workload, increased number of road traffic accidents, poor postures and socioeconomic status, deficient medical or rehab services, and so on. Thus, there is need to conduct a research to determine the effects of low level laser therapy when combined with proprioceptive stimulation in improving patient's functional status, pain and gait issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy with proprioceptive stimulation | Experimental | Other: Low level laser therapy with proprioceptive stimulationPatients will be treated with low level laser therapy and proprioceptive stimulation will also be given. |
| Low level laser therapy without proprioceptive stimulation | Active comparator | Other: Low level laser therapy without proprioceptive stimulationPatients will be treated with low level laser therapy only. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 45-70years(27)
- Both male and female patients
- Patients with acute Low Back Pain and unilateral Discogenic Lumbar Radiculopathy with disc bulge confirmed on MRI
- Pain intensity score is 4 or more on the numeric pain rating scale (NPRS)
- Radiating leg pain symptoms for less than 4 weeks
Key exclusion criteria (6 listed)
- Non willing patients
- Patients with severely cognitive disorders
- History of low back pain for more than 4 weeks
- History of any systemic disease such as Stroke, Multiple Sclerosis, Myopathies, Heart Failure etc
- Botulinum toxin injections to any lower extremity muscle in the last 3 months
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 |
|---|---|---|
| Low level laser therapy with proprioceptive stimulationAlso: Heating packs10 minutes of low level laser therapy and 10-15 minutes of proprioceptive stimulation and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status. | Other | Low level laser therapy with proprioceptive stimulation |
| Low level laser therapy without proprioceptive stimulationAlso: Heating packs10 minutes of low level laser therapy and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status. | Other | Low level laser therapy without proprioceptive stimulation |
Primary outcome
Nottingham Sensory Assessment
Time frame: 6 weeks
Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.
NPRS
Time frame: 6 weeks
It is a common pain screening tool use to assess the severity of pain at moment time. It is '0-10' scale where '0' means 'no pain' and '10' means 'worst pain imaginable'.
Step length
Time frame: 6 weeks
The distance measured in centimeters between the point of initial contact of one foot and the point of initial contact of the opposite foot is referred to as the step length.
Stride Length
Time frame: 6 weeks
The distance covered in centimeters with two consecutive steps, one with each foot.
Walking Cadence
Time frame: 6 weeks
Number of steps taken by an individual in one minute
1 secondary outcome
6 Minute Walk Test (6MWT)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 24239490Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
- Background: PubMed 24768732Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.
- Background: PubMed 20121353Parker SL, Xu R, McGirt MJ, Witham TF, Long DM, Bydon A. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. J Neurosurg Spine. 2010 Feb;12(2):178-82. doi: 10.3171/2009.9.SPINE09410.
- Background: PubMed 19204216Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
- Background: PubMed 35265302Ahmed I, Bandpei MAM, Gilani SA, Ahmad A, Zaidi F. Effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy: A Double-Blind Randomized Controlled Trial. J Healthc Eng. 2022 Feb 27;2022:6437523. doi: 10.1155/2022/6437523. eCollection 2022.
- Background: PubMed 28243143Benditz A, Loher M, Boluki D, Grifka J, Vollner F, Renkawitz T, Maderbacher G, Gotz J. Positive medium-term influence of multimodal pain management on socioeconomic factors and health care utilization in patients with lumbar radiculopathy: a prospective study. J Pain Res. 2017 Feb 14;10:389-395. doi: 10.2147/JPR.S128090. eCollection 2017.
- Background: PubMed 27929617National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/
- 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.
Hira Jabeen principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy with proprioceptive stimulation and Low level laser therapy without proprioceptive stimulation in people with Lumbar Radiculopathy, run by Riphah International University at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Jabeen (03234116506, hira.jabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nottingham Sensory Assessment (time frame: 6 weeks). The study lists 5 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 NCT05953727, which also lists 7 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 20 Jul 2023.