NCT05360121

Brief Summary

This study will highlight LBP management using MET and stretching application among subacute type of back pain

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 20, 2022

Last Update Submit

April 30, 2022

Conditions

Keywords

Low back pain

Outcome Measures

Primary Outcomes (2)

  • Change from Visual Analogue scale scores at 3 weeks

    It is subjective outcome measure for pain intensity on 1 to10 cm scores. The '0 cm' score refers no pain and '10 cm' refers more excruciating pain. Increase in scores suggest worst pain intensity.

    at baseline and 3 weeks

  • Change from Rolland Morris Disability Questionnaire scores at 3 weeks

    It is explore area of function leading to understand the level of disability. It consists of total 24 scores. The '0' score refers no disability and '24' refers maximum disability. Increase in scores suggest worst disability.

    at baseline and 3 weeks

Study Arms (2)

Muscle energy technique+ Thermotherapy +Back Strengthening exercise

EXPERIMENTAL
Other: Muscle energy technique of erector spinae muscleOther: Muscle energy technique of quadratus lumborum muscleOther: Back strengthening exercisesOther: Thermotherapy

General stretching+ Thermotherapy +Back Strengthening exercise

ACTIVE COMPARATOR
Other: Stretching of erector spinae muscleOther: Stretching of quadratus lumborum muscleOther: Back strengthening exercisesOther: Thermotherapy

Interventions

Therapist will develop cross hand position left hand on lower thoracic and right hand on sacrum. Patient will asked to lift shoulder out of couch to contract the lumber erector spinae and apply force twenty percent against therapist force and keep this position of muscle contraction 7 to 10 seconds then 5 second relax . Then therapist will take new position of muscle restriction by slacking and will hold 30 second that position at the end of restriction then will finally end stretch with three repetition. Muscle energy technique of erector spinae muscle.

Muscle energy technique+ Thermotherapy +Back Strengthening exercise

Therapist will take step over the patient off leg and squeezes gently with their thigh. Patient will abduct leg with 20 percent force against the resistance of therapists thigh for 7 to 10 second. the therapist gently and passively will move patient leg towards adduction by squatting down slowly. Therapist at same time with both hands cradling the iliac crest of pelvic for 30 second stretch and 3 repetition.

Muscle energy technique+ Thermotherapy +Back Strengthening exercise

The therapist standing on the side in a way to place his elbow placed on erector spine and apply stretching on the muscle belly in the direction of longitudinal or transverse plane( figure 1).Duration of stretch will be 15 seconds and four repetition.

General stretching+ Thermotherapy +Back Strengthening exercise

Placing patient's legs to one side of the table and upper body also move to the same side in lateral flexion. This position generate a basic gentle stretch of the muscle. The therapist use elbow on tight/ flat part of muscle belly to stretch out the muscle(figure 2). Duration of stretch will be 15 seconds and four repetition

General stretching+ Thermotherapy +Back Strengthening exercise

1. Supine Abdominal Draw In 2. Supine Butt Lift with Arms at Side 3. Abdominal Draw In with Heel Slide 4. Abdominal Draw In with Knee to Chest 5. Abdominal Draw In with feet on the ball 6. Abdominal Draw In with feet on the ball- add movement

General stretching+ Thermotherapy +Back Strengthening exerciseMuscle energy technique+ Thermotherapy +Back Strengthening exercise

Ten minute duration of hot pack given on low back for local superficial heat.

General stretching+ Thermotherapy +Back Strengthening exerciseMuscle energy technique+ Thermotherapy +Back Strengthening exercise

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- low back pain (subacute)
  • VAS score( more than 3 cm)
  • Quadratus lumborum and erector spinae tightness present

You may not qualify if:

  • back pain (specific)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of physical medicine and rehabilitation

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single blinding will be used in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 4, 2022

Study Start

September 15, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations