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SciaticaNCT04155450

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

A study testing Extension Biased External Limb Loading Exercises, McKenzie Extension Exercise Protocol and Moist Heat in people with Sciatica and Low Back Pain, run by Foundation University Islamabad at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Sciatica, Low Back Pain, Low Back Pain, Mechanical
What is being tested?
Extension Biased External Limb Loading Exercises, McKenzie Extension Exercise Protocol and Moist Heat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesPakistan
Study dates
1 Nov 2019to 1 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Lumbar Postural syndrome
  • Lumbar Dysfunction syndrome
  • Post laminectomy/discectomy
  • Spondylolisthesis
  • Osteoporosis/Fractures
  • Cauda equine syndrome
Show all 10Show fewer
  • Recent history of spinal trauma or surgery
  • Lumbar myelopathy
  • Patients with known metabolic diseases
  • Participants having less than 20% ODI scoring

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Foundation University Islamabad

    Islamabad, Federal, 46000

  • Shafi International Hospital

    Islamabad, Federal, 46000

Other trials in Pakistan

About this study

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.

Read the detailed description

Low back pain is one of the most common problem affecting one's daily living activities.

Back pain results from multifactorial etiology with anatomical, psychological, physiological and social consequences and it is often classified as acute, sub-acute and chronic according to pain duration. Upto 71% of people with acute low back pain in primary care report persistent symptoms and therefore there is requirement for effective treatments in those who have not recovered after acute phase. Therapeutic exercises, manual therapy, functional training, modalities, traction, endurance training of back extensors, Kinesio-taping, trigger point therapy, deep friction massage are some of the procedures being safely and effectively applied by physical therapists to combat back discomfort or disorder.

McKenzie Method of Mechanical Diagnostic Therapy (MDT) approach was developed by Robin McKenzie who was a physical therapist from New Zealand back in 1950s. MDT is an appealing modality of treatment focusing on five areas of benefit-including reliable assessment, early prognosis, self-treatment, better outcomes and prevention of recurrence. The evaluation also determine who will get benefit from treatment and who will require another treatment protocols. McKenzie classified the lumbar back pain into three categories i.e. lumbar postural syndrome, lumbar dysfunction syndrome and lumbar derangement syndrome based on symptomatic or mechanical responses observed during repeated lumbar end range movements. The McKenzie Institute Lumbar Spine Assessment will be used to classify the patients into different syndromes and to choose the desired one fulfilling the inclusion criteria of study.

When normal tissues are deformed over a prolonged period it ends with postural syndrome like slouched posture and the postural syndrome may lead to dysfunction or derangement syndromes. Deformation of structures and tissues that causes pain at end ranges of available motion is characterized as dysfunction syndrome. Derangement syndrome is related to displacement of intervertebral disc with or without involvement of radiating pattern of pain along with back pain and fluctuations in symptoms or pain with directional movements can be observed due to force changes on affected intervertebral disc.

Centralizing and Peripherilizing are two important concepts with a strong association towards derangement syndrome. Centralizing reveals that movements or loading moves the most distal pain proximally while Peripherilizing shows movements or loading moves the pain more distally. McKenzie lumbar extension exercises results in reduction, abolition or centralization of symptoms. In Lumbar derangement syndromes following MDT classification system, a subgroup in which symptoms improve with lumbar extension is labeled as posterior derangement syndrome whereas the subgroup in which symptoms improve with lumbar flexion is labeled as anterior derangement syndrome. Work of many researchers, like Peterson, Machado and Paatelma, provided the strongest evidence regarding the validity of McKenzie method of treatment.

Progressive limb loading exercises at lumbar region fall under two categories, one group emphasis on abdominal musculature and the second group emphasize on lumbar extensor musculature. Patient begins from quadruped position and progress towards prone position initiating with low intensity training and progressing towards greater intensity along with spinal compression in case of lumbar extensors. Progression towards prone position at the end range of motion requires greater control of neutral spine thus providing excellent stabilization of lumbar extensors.

A randomized controlled trial on McKenzie treatment approach in people with chronic low back pain conducted by M.H Halliday et al. provide preliminary evidence that treatment effects of McKenzie Exercises are greater when the core principles are followed with significant reduction in pain and disability of 15.2 [95% CI 7.6 to 22.7] and 11.7 [95% CI 5.4 to18.0]. Srivastav et al. conducted a study at mechanical low back pain with significant improvement having p<0.05 at NPRS \& MODI after application of lumbar stabilization exercises along with conventional physical therapy.

An international survey conducted in 15 different countries in 2019 regarding McKenzie classification system involving 64.8% lumbar, 29.6% cervical, 5.6% thoracic spine of 750 patients fulfilling MDT criteria revealed 0.1% postural syndrome, 1.7% dysfunction syndrome, 75.4% derangement and 22.8% other. In derangement syndrome 82.5% were extension biased thus Derangement is the most commonly encountered pain syndrome and extension is so far the most common directional preference.

With the help of this study the investigators can 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 add to the existing pool of knowledge in the fields of conservative spinal management, physical therapy, orthopedic manual therapy and musculoskeletal medicine.

Being tested
Extension Biased External Limb Loading Exercises, McKenzie Extension Exercise Protocol, Moist Heat
Keywords
exercise, manipulation, spinal, rehabilitation, therapy, manual, manual therapy
Medical subject headings
Sciatica, Low Back Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extension Biased External Limb Loading ExercisesOther

    Also called Core stability exercises

    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
  • McKenzie Extension Exercise ProtocolOther

    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
  • Moist HeatOther

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

Study groups in NCT04155450
Study groupRoleWhat they receive
McKenzie Extension with External Limb Loading ProtocolExperimentalMoist 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
Receives: Other: Extension Biased External Limb Loading Exercises; Other: McKenzie Extension Exercise Protocol; Other: Moist Heat
McKenzie Extension GroupActive comparatorMoist 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
Receives: Other: McKenzie Extension Exercise Protocol; Other: Moist Heat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks

  2. 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.

    Measured: 2 weeks

  3. 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.

    Measured: 2 weeks

  4. 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.

    Measured: 2 weeks

  5. 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.

    Measured: 2 weeks

  6. Balance Error Scoring System

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

    Measured: 2 weeks

  7. 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start1 Nov 2019
  3. Primary completion1 May 2020
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155450
Sponsor's protocol ID
FUI/CTR/2019/2
Status last verified
Dec 2021
First submitted
5 Nov 2019
Last updated
20 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Extension Biased External Limb Loading Exercises, McKenzie Extension Exercise Protocol and Moist Heat in people with Sciatica and Low Back Pain, run by Foundation University Islamabad at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (time frame: 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

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