NCT05232435

Brief Summary

to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial

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
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

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

January 12, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

January 12, 2022

Last Update Submit

March 21, 2022

Conditions

Keywords

LBPPilate mat exerciseMET

Outcome Measures

Primary Outcomes (4)

  • pain intensity

    using visual analogue scale.each patient willbe instructed to rate the current level of pain by placing (X) sign across the horizontal VAS line. The distance in millimeters from the lower limit was measured using a ruler. VAS will be assessed before and after the treatment program.as 1:2 mild , 3:6moderate and 7:10 sever pain.

    up to 4 weeks for each group

  • functional disability

    using ronald morris questioneer.The RMDQ is scored by adding up the number of items the patient has ticked. Scores can vary between 0-24. Greater levels of disability are reflected by higher scores

    up to 4 weeks for each group

  • ROM

    using BROMII.Use the two universal inclinometers to make flexion/extension measurements. Measurements with the universal inclinometer need to be with the patient in an upright position. 1. Palpate and mark S1 and T12. Mark on bare skin when possible. This avoids the marks moving with the patient's clothing (Fig.2) 2. Center the two inclinometers over the palpation marks and zero with your finger by spinning the dial (zero would then be at the bottom of the inclinometer). 3. Have the patient flex forward as far as possible (Fig. 3). Note the reading on each inclinometer. 4. The reading on the upper inclinometer is total lumbar flexion. The reading on the lower inclinometer is sacral flexion. The difference between the reading at S1 and T12 is true lumbar flexion. 5. Repeat flexion protocol for extension having the patient extend back for full extension instead of flexing forward

    up to 4 weeks for each group

  • flexibility

    using V sit and reach test.The test is done twice with a short break in between . Scoring: Zero point is at the level of feet. (We note negative values towards our body and positive values outward from our body.) The best trial is recorded in centimeters by best score

    upto 4 weeks for each group

Study Arms (3)

pilate group

EXPERIMENTAL

will receive pilate exercise(1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist) and standard treatment (stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions(3 sessions/week) over a period of four weeks.

Other: pilate mat exercise will be performed

MET

EXPERIMENTAL

will receiveMET treatment for hamstring and erector spinae and standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions (3 sessions/week)over a period of four weeks.

Other: MET

control group

ACTIVE COMPARATOR

will receive standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) only for 12 sessions (3 sessions/week) over a period of four weeks.

Other: control group receive standard treatment

Interventions

pilate group:1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist plus standard treatment(stretch hamstring -stretch lower back - strength abdominal muscles - electrical heat pad)

pilate group
METOTHER

Will receive MET for hamstring and erectorspinae plus standard treatment

MET

electrical heat pad - stretch hamstring - stretch lower back muscles - stregth abdominal muscles

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seventyeight Subjects will be selected from both genders, with age above 18 years.
  • Normal body mass index (BMI) will be included.
  • Participants diagnosed with chronic nonspecific LBP.

You may not qualify if:

  • The participants will be excluded if they had one of the following criteria:
  • Patient with previous back surgery, lumbar disc herniation, spinal deformities.
  • Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
  • History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
  • Pregnant women and Osteoprosis.
  • Leg length discrepancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • hager hekal, PHD student

    faculty of physical therapy

    STUDY CHAIR

Central Study Contacts

hager na hekal, PHD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The trial has 3 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 9, 2022

Study Start

March 30, 2022

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

April 1, 2022

Record last verified: 2022-03