NCT06116058

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 19, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

chronic non specific low back painintegrated nouromuscular inhibition techniqueinstrument assisted soft tissue mobilization technique

Outcome Measures

Primary Outcomes (2)

  • change in lumber proprioception

    change in lumbar proprioception will be measured by dual inclinometer for 3 group pre-and post-treatment

    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

    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)

    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

    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

    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

Study Arms (3)

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

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

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)

Other: control group C conventional physical therapy

Interventions

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

Also known as: technique
Group A: integrated neuromuscular inhibition technique

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.

Also known as: instrument
Group B :Instrument assissted soft tissue mobilization

. 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.

Also known as: exercise
Group C:conventional physical therapy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

MethodsExercise

Intervention Hierarchy (Ancestors)

Investigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Heba S mousa, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double ( participant ,outcomes assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 19, 2023

First Posted

November 3, 2023

Study Start

November 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

November 3, 2023

Record last verified: 2023-10