NCT04156776

Brief Summary

The main objective of the study was to compare the effectiveness of Muscle Energy Technique and Active Isolated Stretching on Erector Spinae Muscle in the management of Mechanical Low back Pain (LBP) and to find out that which technique is better for the treatment of mechanical LBP

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

Study Start

First participant enrolled

July 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

November 6, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

Active Isolated StretchingMuscle Energy TechniqueMechanical Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • Erector Spinae Muscle Length through Measuring Tape

    The length of the erector spinae can be evaluated in seated position with the legs fully flexed off the end of the table. The therapist stands behind the patient and palpates the anterior superior iliac spine (ASIS) bilaterally. The patient was taught and instructed to perform a posterior pelvic tilt, thus flattening the lumbar lordosis by creating lumbar flexion. Then, the patient was instructed to flex forward, attempting to bring the forehead to the knees. The practitioner feels for when the ASIS of the patient begins to move, which would indicate the end of thoracolumbar flexion and would indicate the initiation of an anterior pelvic tilt. Patient's forehead should come within 10 inches of the knees. The therapist had to note that no knee flexion occurred and the movement is coming from the thoracolumbar spine only. In the current study, erector spinae muscle length was measured prior starting the treatment as well as after completing the last treatment session.

    4th week

  • Oswestry Disability Index (ODI)

    ODI is the tool to measure the level of disability in essential conditions. This scale totally focuses on the evaluation of disability and impairment caused due to LBP. It contains 10 questions which are easily understandable. The very first question in the questionnaire is about the intensity of pain while next questions are about the level of disability and impairment caused on activity of daily living (ADLs) which includes "sleep, lifting, walking, sex life, sitting and so forth." Score for each question is from zero, which indicates no intensity, to five which indicates greatest inability due to LBP. Total obtained score of ten questions was calculated which was divided by the total possible score (i.e., 50) and then it was multiplied by hundred. The answer was in percentage. Let's assume, the total score of the patient was 20 and total possible score is 50 then 20/50 x 100 = 40 %.

    4th week

  • Numeric Pain Rating Scale (NPRS)

    NPRS is a tool to measure the pain intensity. Frequently, pain is the main concern of the patient which compelled him/ her to pursue treatment and NPRS is essential tool to gauge pain intensity in routine practice although psychological aspects of pain can also be considered. NPRS contains eleven levels from zero, which presents "no pain", till ten which presents the "worst pain" one can feel, as shown in figure 11. NPRS is an exceptionally easy to quantify pain, can be used by the patient him self and even it can likewise be utilized in people with low proficiency. It is utilized routinely in numerous nations and languages.

    4th week

Secondary Outcomes (1)

  • Lumbar Spine ROM through Inclinometer

    4th week

Study Arms (2)

Group A (MET)

EXPERIMENTAL

Muscle Energy Technique Conventional Treatment

Other: Muscle Energy TechniqueOther: Conventional Treatment

Group B (AIS)

EXPERIMENTAL

Active Isolated Stretching Conventional Treatment

Other: Active Isolated StretchingOther: Conventional Treatment

Interventions

Muscle energy technique was repeated 4 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.

Group A (MET)

The patient was asked to sit in an upright seated position and flex his/her knees 12 to 18 inches. Patient was asked to tuck the chin, exhale, and firmly contract the abdominal muscles as he/she curls their body forward. He/she was also guided not to bounce or make rapid movements at the end range of the active motion. Then, he was asked to move back to the starting position and repeat the same procedure for 8 to 10 times. Stretch on the end range was not more than 2 seconds. This technique was repeated 10 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.

Group B (AIS)

Conventional physical therapy treatment includes the application of moist heating pad for 30 minutes on lower back/ lumbar region prior to the intervention to both groups.

Group A (MET)Group B (AIS)

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having acute mechanical LBP.
  • Patients having restricted ROM.

You may not qualify if:

  • Patients with ankylosing spondylitis.
  • Patient undergone any spinal surgery.
  • Patient having scoliosis.
  • Patient with tumor.
  • Patient with Rheumatoid Arthritis and other systemic diseases.
  • Immobile/ Bed ridden patients.
  • Patients with cognitive Problems. 8. Patients having vertebral compression fracture. 9. Patients with slump test positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (68)

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abdul Ghafoor Sajjad, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were not aware about the groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A (MET) and Group B (AIS)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 7, 2019

Study Start

July 12, 2018

Primary Completion

December 10, 2018

Study Completion

February 25, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations