CTRI

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CTRI Number

CTRI/2024/09/073251 [Registered on: 03/09/2024] Trial Registered Prospectively

Last Modified On:

29/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparative Efficacy of two different types of exercises in low back pain with leg pain

Scientific Title of Study

Comparative Efficacy of Motor control exercise and surface EMG guided exercises in low back pain with lumbar radiculopathy - A single blinded Randomized Clinical Trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Shelina Jahan Tithi
Designation	Masters of physiotherapy
Affiliation
Address	Nopany Institute of Healthcare Studies 2C Nanda Mullick Lane, Girish Park,Kolkata Kolkata WEST BENGAL 700006 India
Phone	9382364697
Fax
Email	shelinavoice1997@gmail.com

Details of Contact Person
Scientific Query

Name	Shilpasree Saha
Designation	Assisstant Professor
Affiliation	Nopany Institute of Healthcare Studies
Address	Department of Physiotherapy, Nopany Institute of Healthcare Studies Kolkata WEST BENGAL 700006 India
Phone	8787528584
Fax
Email	shilpasree@nihs.ac.in

Details of Contact Person
Public Query

Name	Anwesh Pradhan
Designation	Associate Professor
Affiliation	Nopany Institute of Healthcare Studies
Address	Department of Physiotherapy, Nopany Institute of Healthcare Studies Kolkata WEST BENGAL 700006 India
Phone	9856802334
Fax
Email	anwesh@nihs.ac.in

Source of Monetary or Material Support

Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, Pin-700006

Primary Sponsor

Name	Nopany Institute of Healthcare Studies
Address	Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, pin-700006
Type of Sponsor	Private hospital/clinic

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
Dr Shelina Jahan Tithi PT	Nopany Institute of Healthcare Studies	Department of Physiotherapy Kolkata WEST BENGAL	9382364697 shelinavoice1997@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Nopany Institute of Healthcare Studies Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G55\|\|Nerve root and plexus compressionsin diseases classified elsewhere,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Motor Control Exercises	3 sessions /week, for 4 weeks
Comparator Agent	Surface EMG guided exercises	3 sessions/week, for 4 weeks

Inclusion Criteria

Age From	30.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	I.Patients experiencing lower back pain that radiates unilaterally below the knee II.The patients who have already been assessed and diagnosed by a physician by clinical examination and radiological investigations as low back pain with radiculopathy. III. Positive response of Straight Leg Raise (SLR) with symptom reproduction between 40 to 70 degrees. IV. Presence of at least one neurological sign such as motor impairments in dermatomal or sensory changes in myotomal pattern according to nerve roots.

ExclusionCriteria

Details

I.Pain only up to the buttock region
II. Patients with cardio-thoracic conditions
III.Any recent lower limb peripheral nerve repairs
IV. Indication of Surgical intervention, for example, absence of reflexes, muscle
atrophy, and signs compatible with lumbar myelopathy,
V. Diabetic neuropathy
VI.Pregnancy or any gynecological problem

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
I. Pain II.Radicular pain III. Muscle strength IV. Range of motion V. Disability	4 weeks

Secondary Outcome

Outcome	TimePoints
I. Quality of life	4 weeks

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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

Phase 2

Date of First Enrollment (India)

29/09/2024

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details
Modification(s)

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

Pain, Muscle weakness, and postural instability are very common causes of long-term disability related to low back pain with Lumbar radiculopathy worldwide. The incidence of low back pain is estimated between 13% to 31%, and among them,12%-40% of patients with low back pain experience radicular symptoms. Improvement of postural stability and motor control are important predictor for improving the quality of life and functional independence among patients with low back pain with Lumbar radiculopathy. Various approaches are implemented in physiotherapy to improve the patient’s symptoms with low back pain and Lumbar radiculopathy. Motor control and EMG-guided exercises greatly enhance postural control and functional independence by enhancing muscle strength and awareness of muscle actions through audio-visual feedback.

Purpose of study : The purpose of the study is to find out the efficacy of motor control exercise (MCE) and surface EMG-guided exercise to reduce disability and improve the quality of life in patients with low back pain with Lumbar radiculopathy and compare the efficacy of these 2 different techniques.

Methodology: Patients who were referred with complaints of low back pain with radiculopathy were assessed for eligibility. A brief screening of patients was performed using an SLR (straight leg raise) test to confirm a lumbar disc herniation. According to the inclusion-exclusion criteria, 50 patients were selected, among them 16 patients were excluded by not meeting the criteria (n=9), and declined to participate(n= 7). 34 patients were randomly divided into two groups (n=17) to compare the efficacy of motor control exercise and surface EMG-guided exercise. 6 patients from Group B discontinued from mid-intervention, Group A (n= 17) was received motor control exercise, and Group B (n=11) received EMG-guided exercise. Treatment was provided for 3 sessions /week for a total of 4 weeks.

Statistical Analysis: The statistical analysis was conducted using SPSS software version 30.0. The primary analysis used descriptive statistics to analyse the demographic data. Homogeneity of the groups was checked using the Shapiro-Wilk test. Pre (baseline) and post (after 4 weeks) intervention data. Student t-tests were used for the inter-group and within-group data analysis. The level of significance was considered at p<0.05.

Result: The results of the within-group analysis showed significant results with a significant mean difference (p<0.05) in all the outcomes of both Group A and Group B, except for hip adductor strength in Group B. Between-group comparisons revealed no significant differences with a mean difference (p>0.05) between Group A and Group B. Both interventions demonstrated that 4 weeks of intervention results in a similar level of effectiveness in managing low back pain with lumbar radiculopathy. Therefore, the null hypothesis is accepted in this study.