Chronic Non Specific Low Back PainNCT06116058
Integrated Neuromuscular Inhibition Versus Instrument Assisted Soft Tissue Mobilization in Chronic Back Pain
A study testing Experimental: Group A: integrated neuromuscular inhibition technique and Experimental: Group B :Instrument assissted soft tissue mobilization in people with Chronic Non Specific Low Back Pain, run by Cairo University.
Trial summary
this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Non Specific Low Back Pain
- What is being tested?
- Experimental: Group A: integrated neuromuscular inhibition technique and Experimental: Group B :Instrument assissted soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. The patient's age ranged from 18 to 30 years.(Geogre et al, 2021) 2. Patients with low back pain for more than 3 months (pain felt between T12 and the gluteal fold).
- 3. Patient with chronic low back pain 4. Normal body mass index from 18 -25kg/m2.
Who cannot join
- The subjects will be excluded if they have any of the followings:
- Lumbar discogenic lesions or any inflammatory arthritis, tumors, infection involving the lumbar spine.
- Patients with decreased range of motion secondary to congenital anomalies, muscular contracture, or bony block.
- Previous lumbar or hip surgery or trauma.
- Any hip structural abnormality such as malformations, impingements and degeneration.
- Patients With cognitive impairments that would limit their participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Integrated Neuromuscular Inhibition Technique Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Non Specific Low Back Pain
this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain
- Conditions
- Chronic Non Specific Low Back Pain
- Being tested
- Experimental: Group A: integrated neuromuscular inhibition technique, Experimental: Group B :Instrument assissted soft tissue mobilization, control group C conventional physical therapy
- Keywords
- chronic non specific low back pain, integrated nouromuscular inhibition technique, instrument assisted soft tissue mobilization technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Group A: integrated neuromuscular inhibition techniqueOther
Also called technique
will receive integrated neuromuscular inhibition in addition to conventional treatment,INIT which included IC, SCS, and MET for the low back region for the quadratus lumborum( QL) and erector spinae (ES) muscles
Experimental: Group B :Instrument assissted soft tissue mobilizationOther
Also called instrument
IASTM performed on lumbar posterior muscle erector spinae (iliocostalis, longissimus), and quadratus lumborum(QL) The IASTM treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle. Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for an additional 20-seconds, resulting in a total treatment time of approximately 40 seconds.
control group C conventional physical therapyOther
Also called exercise
. The control group will applied general exercise. General exercise were applied with stretching exercises and stationary bicycling for 10-15 minutes14, 15) . Three sets of fifteen repetitions will performed, with rest times of 1 minute between sets during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: integrated neuromuscular inhibition technique | Experimental | Group A: patient will receive integrated neuromuscular inhibition technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods Receives: Other: Experimental: Group A: integrated neuromuscular inhibition technique |
| Group B :Instrument assissted soft tissue mobilization | Experimental | Group B : patient will receive Instrument assissted soft tissue mobilization technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods Receives: Other: Experimental: Group B :Instrument assissted soft tissue mobilization |
| Group C:conventional physical therapy | Active comparator | Group C: patient will receive conventional physical therapy only in the form of ( stretch for hamstring ,illiopoaps ,low back muscle and strenghtning for abdominal ,back muscles and side support exercise and quadriped exercise) Receives: Other: control group C conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lumber proprioception
change in lumbar proprioception will be measured by dual inclinometer for 3 group pre-and post-treatment
Measured: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
chang in pain pressure threshold
change in lower back pain threshold will be measured by pressure algometer for 3 group pre-and post-treatment
Measured: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
Secondary outcomes (3)
chang in lumbar rang of motion(ROM)
lumbar ROM will be measured by dual inclinometer pre-treatment and post treatment
Measured: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
functional disability oFlumbar spine
functional disability will be measured by The Arabic version of Oswestry Disability Index.(ODI)
Measured: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
pain level of lumbar spine
pain level will be measured by visual analoge scale(VAS)
Measured: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non Specific Low Back PainStudies 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
- Model description
- 1. integrated neuromuscular inhibition technique and conventional physical therapy 2. instrument assisted soft tissue mobilization technique and conventional physical therapy 3. conventional physical therapy only
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Salama Mansour Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116058
- Sponsor's protocol ID
- P.T.REC/012/004714
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Neuromuscular Inhibition Technique Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06116058
- Acronym / sponsor ID
- P.T.REC/012/004714
- Conditions
- Chronic Non Specific Low Back Pain
- Keywords
- chronic non specific low back pain, integrated nouromuscular inhibition technique, instrument assisted soft tissue mobilization technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 3 Nov 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.
this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. integrated neuromuscular inhibition technique and conventional physical therapy 2. instrument assisted soft tissue mobilization technique and conventional physical therapy 3. conventional physical therapy only
| Arm | Type | Receives |
|---|---|---|
| Group A: integrated neuromuscular inhibition technique | Experimental | Other: Experimental: Group A: integrated neuromuscular inhibition techniqueGroup A: patient will receive integrated neuromuscular inhibition technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods |
| Group B :Instrument assissted soft tissue mobilization | Experimental | Other: Experimental: Group B :Instrument assissted soft tissue mobilizationGroup B : patient will receive Instrument assissted soft tissue mobilization technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods |
| Group C:conventional physical therapy | Active comparator | Other: control group C conventional physical therapyGroup C: patient will receive conventional physical therapy only in the form of ( stretch for hamstring ,illiopoaps ,low back muscle and strenghtning for abdominal ,back muscles and side support exercise and quadriped exercise) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. The patient's age ranged from 18 to 30 years.(Geogre et al, 2021) 2. Patients with low back pain for more than 3 months (pain felt between T12 and the gluteal fold).
- 3. Patient with chronic low back pain 4. Normal body mass index from 18 -25kg/m2.
Key exclusion criteria (6 listed)
- The subjects will be excluded if they have any of the followings:
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 |
|---|---|---|
| Experimental: Group A: integrated neuromuscular inhibition techniqueAlso: techniquewill receive integrated neuromuscular inhibition in addition to conventional treatment,INIT which included IC, SCS, and MET for the low back region for the quadratus lumborum( QL) and erector spinae (ES) muscles | Other | Group A: integrated neuromuscular inhibition technique |
| Experimental: Group B :Instrument assissted soft tissue mobilizationAlso: instrumentIASTM performed on lumbar posterior muscle erector spinae (iliocostalis, longissimus), and quadratus lumborum(QL) The IASTM treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle. Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for an additional 20-seconds, resulting in a total treatment time of approximately 40 seconds. | Other | Group B :Instrument assissted soft tissue mobilization |
| control group C conventional physical therapyAlso: exercise. The control group will applied general exercise. General exercise were applied with stretching exercises and stationary bicycling for 10-15 minutes14, 15) . Three sets of fifteen repetitions will performed, with rest times of 1 minute between sets during 4 weeks. | Other | Group C:conventional physical therapy |
Primary outcome
change in lumber proprioception
Time frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
change in lumbar proprioception will be measured by dual inclinometer for 3 group pre-and post-treatment
chang in pain pressure threshold
Time frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
change in lower back pain threshold will be measured by pressure algometer for 3 group pre-and post-treatment
3 secondary outcomes
chang in lumbar rang of motion(ROM)
Time frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
functional disability oFlumbar spine
Time frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
pain level of lumbar spine
Time frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Group A: integrated neuromuscular inhibition technique and Experimental: Group B :Instrument assissted soft tissue mobilization in people with Chronic Non Specific Low Back Pain, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Heba S mousa, master (01128524303, salamaheba734@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in lumber proprioception (time frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure). 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 3 Nov 2023.