NCT05174520

Brief Summary

  • Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
  • Alternative hypothesis: There is difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

December 13, 2021

Last Update Submit

August 30, 2022

Conditions

Keywords

Low back painLumbar painBackacheMuscle Energy TechniqueQuadratus Lumborum

Outcome Measures

Primary Outcomes (4)

  • Pain will be assessed by Numeric pain rating scale

    Pain will be measured using 11 point Numeric Pain rating scale (NPRS). 0 score represents no pain, 1-3 score represents mild pain, 4-6 represents moderate pain and 7-10 represents severe pain.

    1 minute

  • Range of Motion will be assessed by Universal Goniometer

    Lumbar flexion, extension and side bending range of motion will be measured using Universal Goniometer. Normal lumbar flexion range is 60 degrees, extension range is 25 degrees, and right and left side bending range is 25 degrees.

    2 minutes

  • Quality of life will be assessed by Medical outcomes study: 20 item Short form survey instrument

    The SF-20 measure contains three dimensions about function (physical, social and role) and well-being (mental health, health perception and pain). score between 75- 100 leveled as good quality of life of low back pain patients, Average QOL marked when QOL score between 50-74, and QOL score between 0-49 leveled as poor QOL.

    8 minutes

  • Functional Disability will be assessed by Oswestry Low Back Pain Disability Index

    Oswestry disability index is a validated, 10-point patient-reported outcome questionnaire. • 0% to 20% is scored as minimal disability. • 21%-40% is scored as moderate disability. • 41%-60% is scored as severe disability. • 61%-80% is scored as crippled. • 81%-100% scored as bedbound patients.

    5 minutes

Study Arms (2)

Routine Physical Therapy group

ACTIVE COMPARATOR

Routine physical therapy group includes thermotherapy for 10 mins, transcutaneous electrical nerve stimulations for 10 mins. Exercises such as: Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions. Treatment duration will be 25 minutes.

Other: Routine Physical Therapy

Experimental group

EXPERIMENTAL

Experimental group includes 6-7 repetitions of Muscle energy technique on Quadratus Lumborum muscle and Routine physical therapy, i.e Thermotherapy, transcutaneous electrical nerve stimulations, Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions. Treatment duration will be 40 minutes.

Other: Muscle Energy Technique

Interventions

Routine physical therapy will be provided to group A for 25 minutes thrice a week for 4 weeks.

Also known as: Conventional Physical Therapy
Routine Physical Therapy group

Muscle Energy technique along with Routine physical therapy will be provided to group B for40 minutes thrice a week for 4 weeks.

Experimental group

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders of age 30 to 55 year.
  • Patients with pain for at least three months or more (chronic stage).
  • Patients having score of at least 3 on 0-10 points(NPRS).
  • Diagnosed patients of low back pain.
  • Non-radicular low back pain.
  • Quadratus Lumborum tightness by physical test i.e. side bending test.

You may not qualify if:

  • Pregnant females.
  • Lumbar radiculopathy.
  • Any spinal pathology i.e. infectious disease and fracture.
  • Any congenital deformity of spine, upper and lower extremities.
  • Systemic illnesses i.e. cardiovascular disorders, respiratory disorders etc.
  • History of surgery of hip, pelvis, lumbar spine, disc herniation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore teaching Hospital

Lahore, Punjab Province, 53700, Pakistan

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • M Waqar Afzal, Mphil-MSK

    University of Lahore

    STUDY CHAIR
  • Syed Asadullah Arslan, Ph.D. PT

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 30, 2021

Study Start

October 27, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations