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Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain

Primary Purpose

Nonspecific Chronic Low Back Pain, Pain, Disability Physical

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
McKenzie back extension exercise
Pilates pelvic tilt exercise
Baseline treatment
Sponsored by
University of Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonspecific Chronic Low Back Pain focused on measuring Pilates pelvic tilt exercise & McKenzie back exercise

Eligibility Criteria

35 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age of the participants between 35-45 years.
  • Only male workers diagnosed with nonspecific chronic low back pain.
  • Power looms workers; Operator of power looms, working 12 hours per day.
  • Low back pain for more than three months.
  • Power looms workers with pain intensity on NPRS ranges from mild to moderate.
  • Anterior pelvic tilt angle more than normal 13º±4.9º, anteriorly tilt to 18º to 25º.

Exclusion Criteria:

  • Serious spinal pathology like tumors.
  • Any inflammatory diseases.
  • History of spinal surgery.
  • Neurological disorder.
  • Pain due to any systemic diseases.

Sites / Locations

  • Dr Hafiz Almas PTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1- McKenzie (Group A)

2- Pilates (Group B)

Arm Description

Back extension exercise. Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month.

Pelvic tilt exercise Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month.

Outcomes

Primary Outcome Measures

Pain intensity
In this study pain intensity of the subjects will be noted via numeric pain rating scale. The reading of NPRS is in number from 0 to 10 where 0 mean no pain, 10 means worst pain, 1-3 indicate mild pain, 4-6 present moderate pain, and 7-10 means severe pain. Patient tell us in numeric form how much he feels pain for example patient tell us he has 4 pain; its mean patient has moderate pain.
Disability index
In this study disability of the patients will be measured via Quebec back pain disability scale. The 20-item Quebec back pain Disability Scale for Back Pain was created to measure degree of functional disability in people who have low back pain. The scale is a dependable and valid measurement used to evaluate each patient's improvement during treatment or rehabilitation programmers.

Secondary Outcome Measures

Anterior pelvic tilt angle abnormailty
In this study goniometer was used to measure the anterior pelvic tilt angle of the power loom workers. Goniometer has three parts the body, stationary arm, and the mobile arm. To check the anterior pelvic tilt angle in subjects the body of the goniometer was placed on the anterior superior iliac spine horizontally, mobile arm was moved to the posterior superior iliac spine and noted the reading displayed on the goniometer.

Full Information

First Posted
July 18, 2022
Last Updated
July 21, 2022
Sponsor
University of Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT05473416
Brief Title
Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain
Official Title
Comparing the Effects of Pilates (Pelvic Tilt) and McKenzie Back Extension Exercises in Power Loom Workers Having Non-specific Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We want to check the effects of Mckenzie intervention & Pilates intervention on power looms workers having nonspecific chronic low back pain
Detailed Description
The purpose of this study is to check and compare the effects of McKenzie back extension exercise and Pilates pelvic tilt exercise on power looms workers having nonspecific chronic low back pain. We want to check the effects of these interventions on pain, disability, and anterior pelvic tilt angle. In this study pain intensity of the subjects will be noted via a numeric pain rating scale. Pain will be measured at baseline, after 2 weeks and 4 weeks of intervention. In this study disability of the patients will be measured via Quebec back pain disability scale. Disability will be measured at baseline, after 2 weeks and 4 weeks of intervention. In this study, a goniometer will be used to measure the anterior pelvic tilt angle. Anterior pelvic tilt angle will be measured at baseline, after 2 weeks and 4 weeks of intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Chronic Low Back Pain, Pain, Disability Physical
Keywords
Pilates pelvic tilt exercise & McKenzie back exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was based on the research design of a randomized clinical trial. The single-blind study, in which participants were blind. The sample size of this study was 46. Patient was divided into 2 groups, 23 in each group.
Masking
Participant
Masking Description
participants were blind
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1- McKenzie (Group A)
Arm Type
Experimental
Arm Description
Back extension exercise. Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month.
Arm Title
2- Pilates (Group B)
Arm Type
Experimental
Arm Description
Pelvic tilt exercise Total 10 repetitions in 1 set. Total 3 sets in a session. Total 3 sessions in a week. Total 12 sessions in a month.
Intervention Type
Other
Intervention Name(s)
McKenzie back extension exercise
Intervention Description
McKenzie's back extension exercise consists; start with your belly facing down on the mat. Angle your legs in line with your hips, point your toes, and breathe into the next movement. Gently bending your elbows, push yourself up off the floor, until you feel the extension in your back. Be mindful not to lock your elbows as you support your weight with your hands and wrists for 10 seconds. Take deep inhales and exhales as you move in and out of the pose. Patients will be performed these activities under the supervision of physiotherapist.
Intervention Type
Other
Intervention Name(s)
Pilates pelvic tilt exercise
Intervention Description
Pilates pelvic tilt exercise consists; lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Pull your belly button in toward your spine, pushing your pelvis up toward the ceiling. Tighten your gluteus and hip muscles as you tilt your pelvis forward. Hold for 10 seconds.
Intervention Type
Other
Intervention Name(s)
Baseline treatment
Other Intervention Name(s)
Postural guidelines + stretch break + rest
Intervention Description
Postural guidelines + proper lifting technique + stretch break Rest
Primary Outcome Measure Information:
Title
Pain intensity
Description
In this study pain intensity of the subjects will be noted via numeric pain rating scale. The reading of NPRS is in number from 0 to 10 where 0 mean no pain, 10 means worst pain, 1-3 indicate mild pain, 4-6 present moderate pain, and 7-10 means severe pain. Patient tell us in numeric form how much he feels pain for example patient tell us he has 4 pain; its mean patient has moderate pain.
Time Frame
Pain will be measured at baseline, after 2 weeks of intervention and 4 weeks of intervention. Total duration will be one month
Title
Disability index
Description
In this study disability of the patients will be measured via Quebec back pain disability scale. The 20-item Quebec back pain Disability Scale for Back Pain was created to measure degree of functional disability in people who have low back pain. The scale is a dependable and valid measurement used to evaluate each patient's improvement during treatment or rehabilitation programmers.
Time Frame
Disability will be measured at baseline, after 2 weeks of intervention and 4 weeks of intervention. Total duration of intervention will be one month
Secondary Outcome Measure Information:
Title
Anterior pelvic tilt angle abnormailty
Description
In this study goniometer was used to measure the anterior pelvic tilt angle of the power loom workers. Goniometer has three parts the body, stationary arm, and the mobile arm. To check the anterior pelvic tilt angle in subjects the body of the goniometer was placed on the anterior superior iliac spine horizontally, mobile arm was moved to the posterior superior iliac spine and noted the reading displayed on the goniometer.
Time Frame
Anterior pelvic tilt angle will be measured at baseline, after 2 weeks of intervention and 4 weeks of intervention.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of the participants between 35-45 years. Only male workers diagnosed with nonspecific chronic low back pain. Power looms workers; Operator of power looms, working 12 hours per day. Low back pain for more than three months. Power looms workers with pain intensity on NPRS ranges from mild to moderate. Anterior pelvic tilt angle more than normal 13º±4.9º, anteriorly tilt to 18º to 25º. Exclusion Criteria: Serious spinal pathology like tumors. Any inflammatory diseases. History of spinal surgery. Neurological disorder. Pain due to any systemic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hafiz Muhammad Almas Sabir Muhammad Sabir Ali, MS OMPT
Phone
92+3326615336
Email
hafizalmas327@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mayra Amjad Amjad Ali, DPT
Phone
92+3086922600
Email
mayraamjad55@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiz Muhammad Almas Sabir Muhammad Sabir Ali, MS OMPT
Organizational Affiliation
The University of Faisalabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Hafiz Almas PT
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HAFIZ ALMAS MUHAMMAD SABIR ALI, MS OMPT
Phone
03326615336
Email
hafizalmas327@gmail.com
First Name & Middle Initial & Last Name & Degree
Mayra Amjad Amjad Ali, DPT
Phone
92+3086922600
Email
mayraamjad55@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain

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