Integrated Neuromuscular Inhibition Versus Instrument Assisted Soft Tissue Mobilization in Chronic Back Pain

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06116058
• Collaborator: (none)
• Enrollment: 45
• Arms: 3
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Chronic Non Specific Low Back Pain	Other: Experimental: Group A: integrated neuromuscular inhibition technique; Other: Experimental: Group B :Instrument assissted soft tissue mobilization; Other: control group C conventional physical therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: integrated neuromuscular inhibition technique and conventional physical therapy instrument assisted soft tissue mobilization technique and conventional physical therapy conventional physical therapy onlyintegrated neuromuscular inhibition technique and conventional physical therapy instrument assisted soft tissue mobilization technique and conventional physical therapy conventional physical therapy only
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double ( participant ,outcomes assessor)
• Primary Purpose: Treatment
• Official Title: Integrated Neuromuscular Inhibition Technique Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Non Specific Low Back Pain
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: integrated neuromuscular inhibition technique Group A: patient will receive integrated neuromuscular inhibition technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods	Other: Experimental: Group A: integrated neuromuscular inhibition 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; Other Names: technique
Experimental: Group B :Instrument assissted soft tissue mobilization Group B : patient will receive Instrument assissted soft tissue mobilization technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods	Other: Experimental: Group B :Instrument assissted soft tissue mobilization; 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.; Other Names: instrument
Active Comparator: Group C:conventional physical therapy 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)	Other: control group C conventional physical therapy; . 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 Names: exercise

Outcome Measures

Primary Outcome Measures

1. change in lumber proprioception [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

2. chang in pain pressure threshold [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

Secondary Outcome Measures

1. chang in lumbar rang of motion(ROM) [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]

   lumbar ROM will be measured by dual inclinometer pre-treatment and post treatment

2. functional disability oFlumbar spine [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 will be measured by The Arabic version of Oswestry Disability Index.(ODI)

3. pain level of lumbar spine [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 will be measured by visual analoge scale(VAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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).

1. Patient with chronic low back pain 4. Normal body mass index from 18 -25kg/m2.

Exclusion Criteria:

• The subjects will be excluded if they have any of the followings:

1. Lumbar discogenic lesions or any inflammatory arthritis, tumors, infection involving the lumbar spine.

2. Patients with decreased range of motion secondary to congenital anomalies, muscular contracture, or bony block.

3. Previous lumbar or hip surgery or trauma.

4. Any hip structural abnormality such as malformations, impingements and degeneration.

5. Patients With cognitive impairments that would limit their participation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heba Salama Mansour Mousa, Principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT06116058
• Other Study ID Numbers: P.T.REC/012/004714
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heba Salama Mansour Mousa, Principal investigator, Cairo University: chronic non specific low back pain; integrated nouromuscular inhibition technique; instrument assisted soft tissue mobilization technique
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Nov 3, 2023