CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2021/11/038248 [Registered on: 25/11/2021] Trial Registered Prospectively

Last Modified On:

24/11/2021

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE VS PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION IN NON-SPECIFIC LOW BACK PAIN

Scientific Title of Study

EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE AS COMPARED TO PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION IN NON-SPECIFIC LOW BACK PAIN : RCT

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Shreya Patel
Designation	BPT Intern
Affiliation	Nootan College Of Physiotherapy
Address	Room No-1 Orthopedic Physiotherapy Department Nootan College Of Physiotherapy Sankalchand Patel University Visnagar Gujarat India Mahesana GUJARAT 384315 India
Phone	9687681851
Fax
Email	shreya16491999@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Pratik Patel
Designation	Tutor
Affiliation	Nootan College Of Physiotherapy
Address	Room No-1 Orthopedic Physiotherapy Department Nootan College Of Physiotherapy Sankalchand Patel University Visnagar Gujarat India Mahesana GUJARAT 384315 India
Phone	7573825777
Fax
Email	pratikp279@gmail.com

Details of Contact Person
Public Query

Name	Dr Pratik Patel
Designation	Tutor
Affiliation	Nootan College Of Physiotherapy
Address	Room No-1 Orthopedic Physiotherapy Department Nootan College Of Physiotherapy Sankalchand Patel University Visnagar Gujarat India GUJARAT 384315 India
Phone	7573825777
Fax
Email	pratikp279@gmail.com

Source of Monetary or Material Support

Room No-1 Orthopedic Physiotherapy Department Nootan College Of Physiotherapy Sankalchand Patel University Visnagar Gujarat India

Primary Sponsor

Name	Nootan College Of Physiotherapy
Address	Room No-1 Orthopedic Physiotherapy Department Nootan College Of Physiotherapy Sankalchand Patel University Visnagar Gujarat India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Shreya Patel	Nootan College Of Physiotherapy	Nootan College Of Physiotherapy Room No-1 Orthopedic Physiotherapy Department Sankalchand Patel University Visnagar Gujarat India Mahesana GUJARAT	9687681851 shreya16491999@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Of Nootan College Of Physiotherapy	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M709\|\|Unspecified soft tissue disorder related to use, overuse and pressure,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Group-A MUSCLE ENERGY TECHNIQUE	MUSCLE ENERGY TECHNIQUE- 10sec.hold, 30sec.rest, 3 rep. for each muscle in 1 set, 1 session/day, Total 30 sessions
Intervention	Group-B PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION	PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION - 30-45 minutes and 10sec.hold, 30sec.rest, 15 rep. in 1 set, 1 session/day, Total 30 sessions
Intervention	Group-C	No intervention will be given.
Comparator Agent	Not Applicable	Not Applicable

Inclusion Criteria

Age From	35.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	Age 35 - 55 years Both male and female participants who are willing to be a part of the study Participants of Low back pain with non-specific nature i.e. without identifying specific anatomical or neurophysiological causative factors. Symptomatic back pain due to overuse, overload & overstretch

ExclusionCriteria

Details

Tumor Acute or traumatic condition
Spondylolisthesis with radiculopathy
Spinal stenosis
Infective conditions like Osteomyelitis Systemic disorders like tuberculosis of the spine Severe postural abnormality
Pain referred from viscera Participants with nerve root pain signs Participants with spinal surgery

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
1.Muscle strength (By Pressure Biofeedback Unit). 2.Intensity of pain (NPRS). 3.Functional disability (Roland-Morris disability questionnaire)	Before Enrollment After 6 weeks of treatment

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

30/11/2021

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="1"
Days="15"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

1. TITLE:

EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE AS COMPARED TO PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION IN NON-SPECIFIC LOW BACK PAIN: RCT

Aim: The study aims to find out the effectiveness of the Muscle energy technique compared to Proprioceptive neuromuscular facilitation in non-specific low back pain.

Objectives:

1) To find out whether there is any significant difference between Muscle energy techniques as compared to Proprioceptive neuromuscular facilitation for reducing pain in participants with low back pain.

2) To find out whether there is any significant difference between the Muscle energy technique as compared to Proprioceptive neuromuscular facilitation in increasing the strength of the back muscle in participants with low back pain.

3) To find out whether there is any significant difference between the Muscle energy techniques as compared to Proprioceptive neuromuscular facilitation in the improvement of function in participants with low back pain.

TOOLS:

1. Pen & Paper

2. Plinth & Pillow

3. Stool

4. Consent Form

5. Assessment Form

6. Functional outcome index

OUTCOME MEASURES:

1. Muscle strength (By Pressure Biofeedback Unit).

2. Intensity of pain (NPRS).

3. Functional disability (Roland-Morris disability questionnaire).

DATA COLLECTION PROCEDURE:

The participants with low back pain will be taken from orthopedic physiotherapy OPD of Nootan College Of Physiotherapy.

First, all the participants will complete a detailed orthopedic assessment. The Orthopedic assessment will obtain information about demographic details, medical history, analysis of pain, investigation reports & functional tests of the participants. Participants will fulfill the selection criteria and inform the study and request to sign a written informed consent form. The procedure will be clearly explained to all the participants and their consent will be obtained. Randomization into groups will be achieved through the lottery method. After that pre-intervention evaluation that includes NPRS, Functional scale (RMDQ) and Pressure Biofeedback Unit (PBU) will be taken.

The treatment will be given to the participants of Group-A and Group-B (Experimental Group). After that post-intervention evaluation also will be done. Each participant will be evaluated prior to the First session and after the last session. The Data will be collected and further used for Statistical Analysis.