NCT05428280

Brief Summary

Institute for Clinical Systems Improvement (ICSI) defines sub-acute low back pain as low back pain lasting between 4 and 12 weeks. There is insufficient evidence regarding the comparative effect of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain with the tightness of quadratus lumborum and erector spinae muscles

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration 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

Study Start

First participant enrolled

December 22, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

June 13, 2022

Last Update Submit

March 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The participant is asked to indicate a point of pain intensity by placing a line perpendicular to the Visual analogue scale line. The scale is most commonly referred by "no pain" with score of 0 and "worst imaginable pain" with score of 100 on the scale. The higher scores shows higher pain intensity and lower scores shows lower pain intensity.

    Change from baseline pain intensity at 4 weeks

  • Rolland Morris Disability Questionnaire

    It is a standard questionnaire with questions regarding pain and the disabling effect on daily activities. Its score ranges from 0 to 24 (no disability to maximum disability)

    Change from baseline functional disability at 4 weeks

Study Arms (2)

Muscle Energy Techniques

EXPERIMENTAL

Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1\. Muscle Energy Technique

Other: PhysiotherapyOther: Muscle Energy technique

Myofascial Mobilization Techniques

ACTIVE COMPARATOR

Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1\. Myofascial Mobilization

Other: PhysiotherapyOther: Myofacial mobilization

Interventions

Conventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise

Muscle Energy TechniquesMyofascial Mobilization Techniques

Muscle Energy Technique (MET) is a technique that was developed in 1948 by Fred Mitchell, Sr, D.O\[1\]. It is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle.

Muscle Energy Techniques

It is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues

Myofascial Mobilization Techniques

Eligibility Criteria

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

You may qualify if:

  • Sub-acute low back pain with the range of 7 to 12 weeks of unresolved symptoms.
  • Positive test of tight Erector spinae muscle and Tight Quadratus Lumboram muscle

You may not qualify if:

  • Spinal malignancy
  • Spinal fracture
  • Spine foraminal stenosis
  • Nerve root compression
  • Radicular symptoms
  • Sciatica
  • Cord compression
  • Paralysis
  • Muscular dystrophy
  • Myelopathy
  • Seizure disorder
  • Severe trauma
  • Unexplained weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

LordosisLow Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Faizan Abdullah, MSAPT, DPT

    Sindh Institute of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 23, 2022

Study Start

December 22, 2021

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations