LaminectomyNCT04498338
Neural Mobilization and Conventional Physical Therapy After Laminectomy
A study testing Neural mobilization combined with conventional physical therapy program and Conventional physical therapy program in people with Laminectomy, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to evaluate the effect of addition of neural mobilization to a standard post-operative physical therapy program in patients with lumbar laminectomy. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Laminectomy
- What is being tested?
- Neural mobilization combined with conventional physical therapy program and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2019to 27 Feb 2020
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged from 35-50 years.
- Underwent lumbar laminectomy of one or two levels.
Who cannot join
- Patients who had arthritis in the joints of the lower limbs (which would limit walking).
- Patients who had tumors, fractures or infections of the spine.
- Patients who had diabetes mellitus.
- Patients who had polyneuropathy.
- Patients who had evidence of spinal cord compression.
- Patients who had previous spinal surgery.
- Patients who had spinal stability problems (e.g. spondilo-listhesis, spondilolysis).
- Patients who had sensory loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neural Mobilization Augmented by Traditional Physical Therapy on Pain, Functional Disability and H-reflex in Patients After Lumbar Laminectomy: a Randomized Controlled Trial
This study was conducted to evaluate the effect of addition of neural mobilization to a standard post-operative physical therapy program in patients with lumbar laminectomy.
Read the detailed description
After Laminectomy, patients are suffering from many problems as pain, weakness. This study was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical treatment for lumbar canal stenosis. The control group received TENS and strengthening exercises, while the study group received neural mobilization in addition to the program that was given to the control group. The outcome measures include pain intensity, nerve root compression and functional level which were measured pre-treatment and post-treatment through using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI) respectively.
- Conditions
- Laminectomy
- Being tested
- Neural mobilization combined with conventional physical therapy program, Conventional physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization combined with conventional physical therapy programOther
Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.
Conventional physical therapy programOther
TENs and exercise program applied 3 times/week for successive 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neural mobilization and conventional physical therapy | Experimental | Neural mobilization combined with conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) were performed three times/week for 6 successive weeks. Receives: Other: Neural mobilization combined with conventional physical therapy program |
| Conventional physical therapy program | Active comparator | Conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) was performed three times/week for 6 successive weeks. Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
It was evaluated through visual analogue scale (VAS). Visual analogue scale (VAS) is a 10-cm line with a "0" at the left end for "no pain" and 10 at the right end for "worst possible pain", each patient was asked to indicate on the line where his pain is in relation to the two extremes by circling the number.
Measured: Up to 6 weeks
Nerve root compression
It was assessed through assessment of latency of H-reflex of S1. The participant was in prone-lying position. The active recording electrode was located on the soleus between the two heads of the gastrocnemius, while reference recording electrode was located on the Achilles tendon. The stimulation was applied at the midline in the popliteal fossa on the tibial nerve.
Measured: Up to 6 weeks
Secondary outcomes (1)
Functional ability
The functional ability was evaluated by Oswestery disability index (ODI). Oswestery disability index (ODI) is a valid and reliable tool for assessment of functional ability.
The minimum value of this scale is 0. The maximum value of this scale is 100. The higher scores mean worse outcome.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start31 Mar 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaminectomyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moussa Abdelfattah Youssif Sharaf, Cairo University
- Investigators
- Moussa A Sharaf, Assist Prof, Principal investigator, Cairo University, EgyptKhalid Z Fouda, Assist Prof, Study director, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498338
- Sponsor's protocol ID
- Interventional
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neural Mobilization Augmented by Traditional Physical Therapy on Pain, Functional Disability and H-reflex in Patients After Lumbar Laminectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04498338
- Acronym / sponsor ID
- Interventional
- Conditions
- Laminectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 4 Aug 2020 (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.
This study was conducted to evaluate the effect of addition of neural mobilization to a standard post-operative physical therapy program in patients with lumbar laminectomy.
Detailed description
After Laminectomy, patients are suffering from many problems as pain, weakness. This study was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical treatment for lumbar canal stenosis. The control group received TENS and strengthening exercises, while the study group received neural mobilization in addition to the program that was given to the control group. The outcome measures include pain intensity, nerve root compression and functional level which were measured pre-treatment and post-treatment through using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI) respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization and conventional physical therapy | Experimental | Other: Neural mobilization combined with conventional physical therapy programNeural mobilization combined with conventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) were performed three times/week for 6 successive weeks. |
| Conventional physical therapy program | Active comparator | Other: Conventional physical therapy programConventional physical therapy program (Transcutaneous electrical nerve stimulation (TENs) and exercise program) was performed three times/week for 6 successive weeks. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged from 35-50 years.
- Underwent lumbar laminectomy of one or two levels.
Key exclusion criteria (8 listed)
- Patients who had arthritis in the joints of the lower limbs (which would limit walking).
- Patients who had tumors, fractures or infections of the spine.
- Patients who had diabetes mellitus.
- Patients who had polyneuropathy.
- Patients who had evidence of spinal cord compression.
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 |
|---|---|---|
| Neural mobilization combined with conventional physical therapy programNeural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks. | Other | Neural mobilization and conventional physical therapy |
| Conventional physical therapy programTENs and exercise program applied 3 times/week for successive 6 weeks. | Other | Conventional physical therapy program |
Primary outcome
Pain intensity
Time frame: Up to 6 weeks
It was evaluated through visual analogue scale (VAS). Visual analogue scale (VAS) is a 10-cm line with a "0" at the left end for "no pain" and 10 at the right end for "worst possible pain", each patient was asked to indicate on the line where his pain is in relation to the two extremes by circling the number.
Nerve root compression
Time frame: Up to 6 weeks
It was assessed through assessment of latency of H-reflex of S1. The participant was in prone-lying position. The active recording electrode was located on the soleus between the two heads of the gastrocnemius, while reference recording electrode was located on the Achilles tendon. The stimulation was applied at the midline in the popliteal fossa on the tibial nerve.
1 secondary outcome
Functional ability
Time frame: Up to 6 weeks
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 Aug 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Laminectomy
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Additional Effects of Pain Neuroscience Education With Standard Pre-operative Physiotherapy on Post-laminectomy Pain and Disability.
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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.
Moussa A Sharaf, Assist Prof principal investigator
Cairo University, Egypt
Khalid Z Fouda, Assist Prof study director
Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization combined with conventional physical therapy program and Conventional physical therapy program in people with Laminectomy, run by Cairo University at 1 site in Egypt.
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 8 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 Aug 2020. 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 Egypt. 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 intensity (time frame: Up to 6 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?
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 Aug 2020.