IRCT | The effects of gluteus medius muscle strengthening and lumbar stabilization exercises in chronic nonspecific low back pain with gluteus medius weakness

Protocol summary

Study aim: To determine the effects of gluteus medius muscle strengthening and lumbar stabilization exercise in chronic nonspecific low back pain with gluteus medius weakness.
Design: A concealed, randomized, double-blinded, clinical trial with a parallel-group design of 18 patients
Settings and conduct: Subjects from Madina University and Teaching Hospital, Faisalabad will be considered. Subjects and assessors are blinded.
Participants/Inclusion and exclusion criteria: Inclusion  Females  Age 18 to 35 years  Having non-specific LBP, defined as pain anywhere from the inferior rib margin to the gluteal fold, for more than 3 months  Less than four out of five gluteus medius muscle strength on manual muscle testing  Numeric Pain Rating score 5 points or higher  Low back pain disability indices 20% or higher Exclusion  A prior history of thoracolumbar or pelvis fracture  Thoracic, abdominal or lumbar spine surgery  Radiculopathy, neurogenic claudication  Primary or secondary spinal tumors  Pregnancy
Intervention groups: Baseline treatment will be given to both groups with Infrared for 10 minutes. One group will receive Lumbar stabilization exercises and other group will receive gluteus medius strengthening protocol.
Main outcome variables: The primary outcome will be self-reported pain. Secondary outcomes will be low back pain-related disability.

General information

Reason for update
Acronym: EGMMSLSECNLBP
IRCT registration information: IRCT registration number: IRCT20191030045287N1

Registration date: 2019-12-01, 1398/09/10

Registration timing: registered_while_recruiting

Last update: 2019-12-01, 1398/09/10

Update count: 0
Registration date: 2019-12-01, 1398/09/10

Registrant information: Name

Nimra Arshad

Name of organization / entity

The University of Faisalabad

Country

Pakistan

Phone

+92 41 8811692

Email address

nimra.arshad@tuf.edu.pk

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-12-01, 1398/09/10
Expected recruitment end date: 2020-01-31, 1398/11/11
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effects of gluteus medius muscle strengthening and lumbar stabilization exercises in chronic nonspecific low back pain with gluteus medius weakness

Public title: Effects of two exercises in chronic nonspecific low back pain with gluteus medius weakness
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Females Age 18 to 35 years Having non-specific LBP, defined as pain anywhere from the inferior rib margin to the gluteal fold, for more than 3 months Less than four out of five gluteus medius muscle strength on manual muscle testing Numeric Pain Rating score 5 points or higher Low back pain disability indices 20% or higher

Exclusion criteria:

A prior history of thoracolumbar or pelvis fracture Thoracic, abdominal or lumbar spine surgery Radiculopathy, neurogenic claudication Primary or secondary spinal tumors Pregnancy Any subject not willing to participate
Age: From 18 years old to 35 years old
Gender: Female

Phase

N/A

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 18

Randomization (investigator's opinion)

Randomized

Randomization description

Convenient sampling will be used for screening the population and then using simple random sampling subjects will be divided into two groups by lottery method. allocation concealment will be carried out.

Blinding (investigator's opinion)

Double blinded

Blinding description

in our study participants and assessors of outcome are blinded as to make sure that no biasness at any level.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of RIPHAH INTERNATIONAL UNIVERSITY LAHORE – PAKISTAN

Street address

13-14-C-Civic Center, Near Hamdard Chowk, Township, Lahore

City

Lahore

Postal code

54000
Approval date: 2019-07-19, 1398/04/28
Ethics committee reference number: RCRS-RE-MS-OMPT/SPRING 19/011

Health conditions studied

1

Description of health condition studied: nonspecific low back pain with gluteus medius weakness
ICD-10 code: M54.5
ICD-10 code description: Low back pain

Primary outcomes

1

Description: pain
Timepoint: before intervention, 4 and 8 weeks after intervention
Method of measurement: Numeric pain rated scale(NPRS)

Secondary outcomes

1

Description: low back pain- related disability
Timepoint: before intervention, 4 and 8 weeks after intervention
Method of measurement: Oswestry disability index (ODI)

Intervention groups

1

Description: Intervention group: The stabilization exercise protocol will be based on the protocols utilized by Hicks and colleagues and Rabin and colleagues. They used a series of four exercises designed to improve the stabilizing function of the abdominal musculature using the abdominal drawing-in maneuver (ADIM) in various activities. Exercise Progression Criterion Quadruped Progression ADIM in quadruped30 reps with 8 sec hold ADIM in quadruped, UE lifts30 reps with 8 sec hold, both sidesADIM in quadruped, LE lifts30 reps with 8 sec hold, both sidesADIM in quadruped, UE & LE lifts30 reps with 8 sec hold, both sidesADIM in quadruped, dynamic UE & LE liftsSupine ProgressionADIM in supine30 reps with 8 sec holdADIM in supine, heel slides20 reps with 4 sec hold, both sidesADIM in supine, LE lift20 reps with 4 sec hold, both sidesADIM in supine, bridge30 reps with 8 sec holdADIM in supine, SLS bridge30 reps with 8 sec hold, both sidesADIM in supine, curl up, elbows at sides30 reps with 8 sec holdADIM in supine, curl up, elbows elevated30 reps with 8 sec holdADIM in supine, curl up, hands at headSidelying ProgressionADIM in sidelying, side plank, knees bent30 reps with 8 sec hold, both sides ADIM in sidelying, side plank, knees extended30 reps with 8 sec hold, both sidesADIM in sidelying, side plank with tilt30 reps with 4 tilts A/P, both sidesADIM in sidelying, side plank with rollStanding ProgressionADIM in standing30 reps with 8 sec holdADIM in standing, row30 reps with 8 sec holdADIM in standing, walking
Category: Rehabilitation

2

Description: Intervention group: gluteus medius strengthening protocol;The gluteus medius strengthening group will perform exercises targeting the gluteus medius muscle.Progression Criterion Supine ProgressionBridge30 reps with 8 sec hold Bridge with Arms Crossed 30 reps with 8 sec hold Bridge with Arms Crossed & Feet Together 30 reps with 8 sec holdSLS BridgeSidelying Progression Clam at 45 degrees30 reps with 8 sec hold Sidelying hip abduction, knees extended30 reps with 8 sec holdSide plank, knees bent 30 reps with 8 sec hold Side plank, knees extended Squat Progression Squat30 repsSLS mini squat30 repsSLS squat Standing Progression 1 Standing abduction30 reps Standing abduction, yellow band30 reps Standing abduction, red band 30 repsStanding abduction, green band 30 reps Standing abduction, blue band 30 reps Standing abduction, black bandStanding Progression 2 Standing abduction with extension 30 reps Standing abduction with extension, yellow band30 repsStanding abduction with extension, red band 30 repsStanding abduction with extension, green band30 repsStanding abduction with extension, blue band30 repsStanding abduction with extension, black band
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Madina University Faisalabad

Full name of responsible person

Dr. Sidra majeed ;PT

Street address

Sargodha Road, University Town, Faisalabad, Punjab 38000

City

Faisalabad

Postal code

38000

Phone

+92 41 8868326

Email

sidra.majeed@tuf.edu.pk

2

Recruitment center: Name of recruitment center

Madina Teaching Hospital, Faisalabad

Full name of responsible person

Dr. Junaid azam;PT

Street address

Sargodha Road, University Town, Faisalabad, Punjab 38000

City

Faisalabad

Postal code

38000

Phone

+92 41 8869861

Email

junaidazam239@yahoo.com

1

Sponsor: Name of organization / entity

Riphah International University

Full name of responsible person

Dr.salman bashir;PT

Street address

Riphah International University 13-14-C-Civic Center, Near Hamdard Chowk, Township,, Lahore

City

Lahore

Postal code

54000

Phone

+92 42 35126110

Email

salman.bashir@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Riphah International University
Proportion provided by this source: 100
Public or private sector: Private
Domestic or foreign origin: Foreign
Category of foreign source of funding: Sponsor: country of origin
Country of origin: PK
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

The University of Faisalabad

Full name of responsible person

nimra Arshad

Position

Clinical Supervisor

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

House no 91,street no 4,Muslim town no 3,Sargodha road Faisalabad

City

Faisalabad

Province

Punjab

Postal code

38000

Phone

+92 41 8811692

Email

nimraarshad70@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

The University of Faisalabad

Full name of responsible person

Nimra Arshad

Position

Clinical Supervisor

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

House no 91,street no 4,Muslim town no 3,Sargodha road Faisalabad

City

Faisalabad

Province

Punjab

Postal code

38000

Phone

+92 41 8811692

Email

nimraarshad70@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

The University of Faisalabad

Full name of responsible person

Nimra Arshad

Position

Clinical Supervisor

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

House no 91,street no 4,Muslim town no 3,Sargodha road Faisalabad

City

Faisalabad

Province

Punjab

Postal code

38000

Phone

+92 41 8811692

Email

nimraarshad70@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

The effects of gluteus medius muscle strengthening and lumbar stabilization exercises in chronic nonspecific low back pain with gluteus medius weakness