Clinical trial NCT05840666: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to three study arms and each study arm will be allocated a different intervention
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 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.
measure: Lumbar Range of Motion
timeFrame: 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.
measure: Level of Functional Disability
timeFrame: 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.
measure: Change in Fear Avoidance Beliefs
timeFrame: 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.
measure: Change in Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Prof. Dr Ashfaq Ahmed, PhD
role: STUDY_CHAIR
References: