Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome

NCT04155450 | Completed

• 1 other identifier: FUI/CTR/2019/2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Low back pain is one of the most common problem affecting one's daily living activities. McKenzie Method of Mechanical Diagnostic Therapy (MDT) is an appealing modality of treatment. McKenzie classified the lumbar back pain into three categories i.e. lumbar postural syndrome, lumbar dysfunction syndrome and lumbar derangement syndrome. Progressive extension bias limb loading exercises at lumbar region emphasizes on lumbar extensor musculature. The purpose of the current study is to determine the effects of extension biased lumbar limb loading exercises along with McKenzie extension protocols in the management of patients with lumbar derangement syndrome, which will also be a cost effective management option. It will also add to the existing pool of knowledge in the fields of conservative low back pain treatment, physical therapy, orthopedic manual therapy and musculoskeletal medicine.

Conditions

Sciatica; Low Back Pain; Low Back Pain, Mechanical

Keywords

exercise; manipulation, spinal; rehabilitation; therapy, manual; manual therapy

Outcome Measures

Primary Outcomes (7)

• Oswestry Disability Index

  Oswestry Disability Index (ODI) assess symptoms and severity of low back pain in terms of disablement and the degree to which back pain impacts functional activities. Questionnaire has been designed to give us information as to how one's back or leg pain is affecting his/her ability to manage in everyday life. It has good person and item reliability with an excellent test retest reliability (ICC= 0.97) and floor effect of 29.9% and ceiling effect of 3.9%. ODI will be assessed at the base line and at the end of 2 weeks session. Lower score shows better outcome.

  2 weeks

• Fall Risk Test

  Biodex Balance System has a fall risk screening test and conditioning protocol based on well-established science and technology. Screening include analytical balance testing by identifying a potential problem and establishes Z-Score on the basis of mean values. Fall risk will be assessed at the base line and at the end of 2 weeks session. Lower score shows better outcome.

  2 weeks

• Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.

  Postural stability screening test will be used to determine the postural stability index of the participants.

  2 weeks

• Range of Motion

  Lumbar ROM including Forward bending, Backward bending, Right side bending and Left side bending will be measured using Inclinometers. ROM will be assessed at the base line and at the end of 2 weeks session. Greater range shows better outcome.

  2 weeks

• Clinical Test of Sensory Integration of Balance

  Clinical Test of Sensory Integration of Balance (CTSIB) will be assessed at the base line and at the end of 2 weeks session.

  2 weeks

• Balance Error Scoring System

  Balance Error Scoring System (BESS) will be assessed at the base line and at the end of 2 weeks session.

  2 weeks

• STarT Back Screening Tool

  The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. STarT will be assessed at the base line and at the end of 2 weeks session.

  2 weeks

Study Arms (2)

McKenzie Extension with External Limb Loading Protocol

EXPERIMENTAL

Moist Heat Pack for 10 mins McKenzie Extension Exercise Protocol Static: 1. Lying Prone 2. Lying prone in extension 3. Sustained extension 4. Posture correction Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing Limb loading for basic stabilization progression of the lumbar extensors. Begin in the quadruped position and progress the intensity by 1. Flexing one upper extremity 2. Extending one lower extremity with a leg slide 3. Extending one lower extremity by lifting it off the mat 4. Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities. Progress to prone position: 5. Extending one lower extremity 6. Extending both lower extremity

Other: Extension Biased External Limb Loading Exercises; Other: McKenzie Extension Exercise Protocol; Other: Moist Heat

McKenzie Extension Group

ACTIVE COMPARATOR

Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence Static: 1. Lying Prone 2. Lying prone in extension 3. Sustained extension 4. Posture correction Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

Other: McKenzie Extension Exercise Protocol; Other: Moist Heat

Interventions

Extension Biased External Limb Loading Exercises OTHER

Begin in the quadruped position and progress the intensity by 1. Flexing one upper extremity 2. Extending one lower extremity with a leg slide 3. Extending one lower extremity by lifting it off the mat 4. Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities. Progress to prone position: 5. Extending one lower extremity 6. Extending both lower extremity

Also known as: Core stability exercises

McKenzie Extension with External Limb Loading Protocol

McKenzie Extension Exercise Protocol OTHER

Static: 1. Lying Prone 2. Lying prone in extension 3. Sustained extension 4. Posture correction Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

McKenzie Extension Group; McKenzie Extension with External Limb Loading Protocol

Moist Heat OTHER

Moist Heating for 10 minutes at lumbar spine in prone position using moist heat packs, heated via hydro-collator.

McKenzie Extension Group; McKenzie Extension with External Limb Loading Protocol

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of age 30 to 50 years
• Patients of both Gender i.e. Male \& Female
• Lumbar Derangement Syndrome
• Centralization or Peripheralization phenomenon
• Constant or Intermittent pain worsening on repeated movements
• Somatic, radicular or combination of both patterns of pain
• Positive Radicular signs \& symptoms

You may not qualify if:

• Lumbar Postural syndrome
• Lumbar Dysfunction syndrome
• Post laminectomy/discectomy
• Spondylolisthesis
• Osteoporosis/Fractures
• Cauda equine syndrome
• Recent history of spinal trauma or surgery
• Lumbar myelopathy
• Patients with known metabolic diseases
• Participants having less than 20% ODI scoring

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (2)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

Location

Shafi International Hospital

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Sciatica; Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Behavior

Study Officials

• Shoaib Kayani, DPT, MS-OMPT*

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

• Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD*

  Foundation University Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is unaware of the treatment group he is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: November 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)