Back to resultsMulligan Sustained Natural Apophyseal Glides Versus McKenzie Method in Patients With Non-Specific Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan Sustained Natural Apophyseal Glide (SNAG)
McKenzie Method
Conventional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Non-specific Low Back Pain, Sustained Natural Apophyseal Glide, McKenzie Method, Mechanical Diagnosis and Therapy, Range of Motion, Pain, Functional Disability, Fear Avoidance Beliefs
Eligibility Criteria
Inclusion Criteria: Patients of Both genders Adult patents between the 20 to 45 years of age with chronic non-specific low back pain. Pain intensity of at least 3 or greater on 0-10 Numeric Rating Scale. Modified Low Back Pain Disability Questionnaire score equal to or greater than 20%. Exclusion Criteria: Serious underlying pathology with red flags. Patients having contraindication to physical exercises. Females with high parity. Pregnant or lactating females. Patients who participated in any type of rehabilitative training or exercise program for back pain in last 1 month. Spinal deformity or Spinal stenosis. History of fall or trauma to spine in last one year. History of spinal, abdominal or hip surgery. Signs of nerve root compression with sensory, motor or deep tendon reflexes deficit. Serious underlying pathology with red flags. Systemic disease e.g., cardiovascular, metabolic or central nervous system. Osteopenia, osteoporosis. Medication's history (steroids, immunosuppressants, chemotherapy) Limb length discrepancy.
Sites / Locations
- The University of Lahore
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Conventional Physical Therapy (CPT) Group
Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group
Conventional Physical Therapy plus McKenzie MDT Group
Arm Description
Conventional Physical Therapy will consist of Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises. Participants will receive 15 sessions of Conventional Physical Therapy (CPT) at a frequency of 5 sessions per week.
Besides Conventional Physical Therapy, Mulligan Mobilizations will be provided in this group. It consist of Extension SNAGS in prone, and Lumbar flexion SNAGS in sitting. The techniques will be applied in 3 sets with 10 repetitions and 60 seconds rest between sets.
Along with Conventional Physical Therapy, McKenzie MDT will be be given in this group. It consist of Prone lying, Prone lying Elbow popups, Prone elbow Extension. Standing Extension, supine Both Knee to Chest, Sitting on chair with forward flexion. The techniques will be applied in 3 sets with 8-10 repetitions and 60 seconds rest between sets.
Outcomes
Primary Outcome Measures
Pain Intensity
Level of pain intensity will be measured using Numeric Rating Scale. The 11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Lumbar Range of Motion
Lumbar Range of motion will be measured using inclinometers. Normal lumbar range of motion include 60 degrees of flexion, 25 degrees of extension, and 25 degrees of lateral bending
Level of Functional Disability
Functional Disability will be measured with the Modified Low Back Pain Disability Questionnaire. The scores range from 0-100% with lower scores meaning less disability.
Change in Fear Avoidance Beliefs
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Change in Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA)
Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA) will be measured with Rehabilitative Ultrasound Imaging (RUSI).The activation of muscle is represented through change in thickness level of muscle observed through RUSI. The normal thickness of TrA is 3.93mm and LM is 28.99mm.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05840666
Brief Title
Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method in Patients With Non-Specific Chronic Low Back Pain
Official Title
Effects of Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method of Mechanical Diagnosis & Therapy in Patients With Non-Specific Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ayesha Jamil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low back pain (LBP) is the most frequent complaint encountered in clinical practice. Exercises and manual therapy prescription are common physical therapy treatments prescribed for the patients presenting with chronic low back pain. The interventions will establish the future direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research
Detailed Description
A variety of treatment interventions, modalities and techniques are used in physical therapy management of non-specific low back pain including manual therapy, exercises, neural mobilizations, stretching soft tissue techniques and dry needling etc. Out of these more recent literature supports manual therapy, self exercises, patient counseling and awareness have been recommended in back pain management guidelines, in the United States and is also frequently used in clinical practice in various countries.
Despite multiple theoretical frame works proposing the role of SNAGs and MDT mobilizations and exercises respectively, the literature on the true mechanism of direct or indirect physiological effects of these on performance or performance-related outcomes is vague and lacks justifiable procedural rigor.
The results of this study will provide information regarding the direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Non-specific Low Back Pain, Sustained Natural Apophyseal Glide, McKenzie Method, Mechanical Diagnosis and Therapy, Range of Motion, Pain, Functional Disability, Fear Avoidance Beliefs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to three study arms and each study arm will be allocated a different intervention
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be unaware of the treatment group of study.
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Physical Therapy (CPT) Group
Arm Type
Active Comparator
Arm Description
Conventional Physical Therapy will consist of Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises. Participants will receive 15 sessions of Conventional Physical Therapy (CPT) at a frequency of 5 sessions per week.
Arm Title
Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group
Arm Type
Experimental
Arm Description
Besides Conventional Physical Therapy, Mulligan Mobilizations will be provided in this group. It consist of Extension SNAGS in prone, and Lumbar flexion SNAGS in sitting. The techniques will be applied in 3 sets with 10 repetitions and 60 seconds rest between sets.
Arm Title
Conventional Physical Therapy plus McKenzie MDT Group
Arm Type
Experimental
Arm Description
Along with Conventional Physical Therapy, McKenzie MDT will be be given in this group. It consist of Prone lying, Prone lying Elbow popups, Prone elbow Extension. Standing Extension, supine Both Knee to Chest, Sitting on chair with forward flexion. The techniques will be applied in 3 sets with 8-10 repetitions and 60 seconds rest between sets.
Intervention Type
Other
Intervention Name(s)
Mulligan Sustained Natural Apophyseal Glide (SNAG)
Other Intervention Name(s)
Mulligan Mobilization
Intervention Description
Application of the MWM technique developed by Brian R. Mulligan. The clinical researcher will perform and holds sustained passive segmental glide at the target joint maintaining the slack whereas the patient will actively move in the direction of pain or stiffness. These MWM techniques when applied to spinal segments or joint is called sustained natural apophyseal glide (SNAG).
Intervention Type
Other
Intervention Name(s)
McKenzie Method
Other Intervention Name(s)
Mechanical Diagnosis and Therapy (MDT)
Intervention Description
An active therapy technique involving repeated movements or sustained positions along with an educational component prescribed to the patient for of minimizing the pain and disability and increase the spinal range of motion. The method will involve the assessment of symptomatic and mechanical responses to repeated movements and sustained positions in the direction of preference. The method will be used for assessment and treatment of patients and with derangement syndrome.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
It includes usual physical therapy care such as Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Level of pain intensity will be measured using Numeric Rating Scale. The 11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain
Time Frame
Pain intensity will be recorded as baseline at the time of recruitment and change in pain intensity will be observed at follow up at the end of 3rd week of treatment.
Title
Lumbar Range of Motion
Description
Lumbar Range of motion will be measured using inclinometers. Normal lumbar range of motion include 60 degrees of flexion, 25 degrees of extension, and 25 degrees of lateral bending
Time Frame
Lumbar Range of Motion will be observed as baseline at the time of recruitment and change in ROM will be observed at follow up at end of 3rd week of treatment.
Title
Level of Functional Disability
Description
Functional Disability will be measured with the Modified Low Back Pain Disability Questionnaire. The scores range from 0-100% with lower scores meaning less disability.
Time Frame
Functional Disability will be recorded as baseline at the time of recruitment and change in score of functional disability will be recorded at the end of 3rd week of treatment.
Title
Change in Fear Avoidance Beliefs
Description
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
Fear Avoidance Beliefs will be observed as baseline at the time of recruitment and any change in Fear Avoidance Beliefs will be observed at the end of 3rd week of treatment.
Title
Change in Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA)
Description
Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA) will be measured with Rehabilitative Ultrasound Imaging (RUSI).The activation of muscle is represented through change in thickness level of muscle observed through RUSI. The normal thickness of TrA is 3.93mm and LM is 28.99mm.
Time Frame
The Thickness of muscles will be recorded as baseline at the time of recruitment and change in thickness representing activation will be measured at follow up at the end of 3rd week of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of Both genders
Adult patents between the 20 to 45 years of age with chronic non-specific low back pain.
Pain intensity of at least 3 or greater on 0-10 Numeric Rating Scale.
Modified Low Back Pain Disability Questionnaire score equal to or greater than 20%.
Exclusion Criteria:
Serious underlying pathology with red flags.
Patients having contraindication to physical exercises.
Females with high parity.
Pregnant or lactating females.
Patients who participated in any type of rehabilitative training or exercise program for back pain in last 1 month.
Spinal deformity or Spinal stenosis.
History of fall or trauma to spine in last one year.
History of spinal, abdominal or hip surgery.
Signs of nerve root compression with sensory, motor or deep tendon reflexes deficit.
Serious underlying pathology with red flags.
Systemic disease e.g., cardiovascular, metabolic or central nervous system.
Osteopenia, osteoporosis.
Medication's history (steroids, immunosuppressants, chemotherapy)
Limb length discrepancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr Ashfaq Ahmed, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants data that underlies the results after de-identification
IPD Sharing Time Frame
Immediately after publication
IPD Sharing Access Criteria
Researchers who provide methodological sound proposal
Learn more about this trial
Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method in Patients With Non-Specific Chronic Low Back Pain
We'll reach out to this number within 24 hrs