NCT05473416

Brief Summary

to check the effects of Mckenzie intervention \& Pilates intervention on power looms workers having nonspecific chronic low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2022

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

July 18, 2022

Last Update Submit

December 2, 2023

Conditions

Keywords

Pilates pelvic tilt exercise & McKenzie back exercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    one month

  • 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.

    one month

Secondary Outcomes (1)

  • Anterior pelvic tilt angle abnormailty

    one month

Study Arms (2)

1- McKenzie (Group A)

EXPERIMENTAL

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.

Other: McKenzie back extension exerciseOther: Baseline treatment

2- Pilates (Group B)

EXPERIMENTAL

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.

Other: Pilates pelvic tilt exerciseOther: Baseline treatment

Interventions

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.

1- McKenzie (Group A)

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.

2- Pilates (Group B)

Postural guidelines + proper lifting technique + stretch break Rest

Also known as: Postural guidelines + stretch break + rest
1- McKenzie (Group A)2- Pilates (Group B)

Eligibility Criteria

Age35 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly Male
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Hafiz Almas PT

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hafiz Muhammad Almas Sabir Muhammad Sabir Ali, MS OMPT

    The University of Faisalabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants were blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 25, 2022

Study Start

August 15, 2022

Primary Completion

November 13, 2022

Study Completion

December 24, 2022

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations