NCT04801212

Brief Summary

Core stability strength \& coordination is necessary to perform smooth \& coordinated upper \& lower extremity movements \& function. Altered core stability muscle strength, coordination \& poor motor control can cause low back pain (LBP). Physical therapists especially those working with children having neurodevelopmental problems or adults with neurological disorders such as stroke are aware of the concepts of global movements. In this concept, alterations in one body segment may bring changes in other body segments. In neurological rehabilitation, the concept of Neuro-Developmental Technique (NDT) introduced by Bobath got worldwide recognition. This concept states that there are specific key points in the neck, \& shoulders that can facilitate normal movements by enhancing the activity of core musculature in functional movements for instance, sit to stand \& walking. This concept was further explored by Burnstein and suggested that biomechanically body joints and motor control works together as functional unit and not as single limb movement. Bobath and proprioceptive neuromuscular facilitation (PNF) concepts further explained that movements of the eye, head and neck facilitate trunk movements. Electromyography studies have shown that both single and rhythmical jaw opening and closing movements not only produced well-coordinated jaw and head-neck movements but also produced atlanto-occipital and cervical spine joints movements. The author further concluded that mouth opening and closing in fetal yawning is associated with head extension-flexion movements indicating that functional connections between the jaw and head-neck is innate. A human jaw or masticatory system is connected to the motor system through cranial nerves unlike central motor system which is connected to the body through spinal motor system. Brainstem central pattern generator (CPG) control masticatory system through descending pathways and are involved in voluntary movements of the jaw such as mouth opening and closing. The higher brain centers cortical masticatory area and primary motor cortex control these movements. In the current back pain literature core stability exercises have been used in the management of chronic low back pain. The jaw is connected to the head-neck and neck is connected to the trunk. Therefore there is to study the effects of core stability exercises performed with and without jaw movements in the management of chronic low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

February 3, 2021

Last Update Submit

May 3, 2023

Conditions

Chronic Nonspecific Low Back PainCore StabilityJaw MovementsTemporomandibular Joint

Outcome Measures

Primary Outcomes (9)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.

    At baseline

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.

    At 6th weeks

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.

    At 12th weeks

  • Roland Morris Questionnaire (RMQ):

    RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.

    At baseline

  • Roland Morris Questionnaire (RMQ):

    RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.

    At 6th weeks

  • Roland Morris Questionnaire (RMQ):

    RMQ is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.

    At 12th weeks

  • Pressure Biofeedback unit (PBU):

    Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .

    At baseline

  • Pressure Biofeedback unit (PBU):

    Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .

    A 6th weeks

  • Pressure Biofeedback unit (PBU):

    Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .

    At 12th weeks

Study Arms (2)

core stability exercises with teeth clenching

EXPERIMENTAL

The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention, both groups will be given a home exercise program consist of same exercises they have carried out in the clinic for the duration another 6 weeks. The participants will be asked to keep diaries of their exercises they have carried out each week.

Other: core stability exercises with teeth clenchingOther: core stability exercises

core stability exercises alone

ACTIVE COMPARATOR

The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention, both groups will be given a home exercise program consist of same exercises they have carried out in the clinic for the duration another 6 weeks. The participants will be asked to keep diaries of their exercises they have carried out each week.

Other: core stability exercises

Interventions

core stability exercises with teeth clenchingOTHER

The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention.

core stability exercises with teeth clenching
core stability exercisesOTHER

The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention.

core stability exercises alonecore stability exercises with teeth clenching

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • · Participants having chronic low back pain lasting more than 12 weeks.
  • Age 20-45 years
  • Participants having nonspecific chronic low back pain with or without referred leg pain.
  • Both male and female patients.
  • Currently seeking care for low back pain.
  • No known TMJ pathology.
  • Had Magnetic Resonance Image (MRI) to exclude serious pathology and been diagnosed by the consultant and non-specific low back pain.

You may not qualify if:

  • · Participants with known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome/widespread neurological disorder, lumbar spondylosis, stenosis, spondylolisthesis).
  • Compromised nerve root
  • Previous spinal surgery or scheduled for major surgery during the treatment.
  • Co-morbid health conditions that would prevent active participation in the exercise programs such as asthma.
  • Low back pain having less than 12 weeks history.
  • Known Temporomandibular joint pathology or jaw pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine & Rehabilitation

Karachi, Sindh, 75400, Pakistan

Location

Related Publications (10)

  • Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004.

    PMID: 20434958BACKGROUND

  • Sung PS. Disability and back muscle fatigability changes following two therapeutic exercise interventions in participants with recurrent low back pain. Med Sci Monit. 2013 Jan 14;19:40-8. doi: 10.12659/msm.883735.

    PMID: 23314589BACKGROUND

  • Raine S, Meadows L, Lynch-Ellerington M. Bobath Concept: Theory and Clinical Practice in Neurological Rehabilitation. Wiley-Blackwell. 2009. 4- Bernstein, N. The Coordination and Regulation of Movement. Pergamon Press, Oxford. Bishop, B. 1967.

    BACKGROUND

  • Adler SS, Beckers D, Buck M. PNF in Practice: An Illustrated Guide. New York, NY: Springer. 2007.

    BACKGROUND

  • Voss DE, Ionta MK, Myers BJ. Proprioceptive Neuromuscular Facilitation. Patterns and Techniques. Philadelphia, PA: Harper & Row Publishers. 1985.

    BACKGROUND

  • HUMPHREY T. The spinal tract of the trigeminal nerve in human embryos between 7 1/2 and 8 1/2 weeks of menstrual age and its relation to early fetal behavior. J Comp Neurol. 1952 May;97(1):143-209. doi: 10.1002/cne.900970109. No abstract available.

    PMID: 12981197BACKGROUND

  • Zafar H, Eriksson PO, Nordh E, Haggman-Henrikson B. Wireless optoelectronic recordings of mandibular and associated head-neck movements in man: a methodological study. J Oral Rehabil. 2000 Mar;27(3):227-38. doi: 10.1046/j.1365-2842.2000.00505.x.

    PMID: 10784335BACKGROUND

  • Zafar H, Nordh E, Eriksson PO. Temporal coordination between mandibular and head-neck movements during jaw opening-closing tasks in man. Arch Oral Biol. 2000 Aug;45(8):675-82. doi: 10.1016/s0003-9969(00)00032-7.

    PMID: 10869479BACKGROUND

  • Barry J. Sessle ,LimorAvivi-Arber, and Gregory M. Murray. Motor Control of Masticatory Muscles. Craniofacial Muscles: A New Framework for Understanding the Effector Side of Craniofacial Muscle Control. L.K. McLoon and F.H. Andrade (eds.) Toronto. 2013.

    BACKGROUND

  • Khan M, Zafar H, Gilani SA, Farooqui WA, Ahmad A. The effects of lumbar stabilization exercises with and without jaw movements in non-specific low back pain (A randomized controlled trial). Pak J Med Sci. 2024 Jul;40(6):1116-1121. doi: 10.12669/pjms.40.6.9208.

    PMID: 38952498DERIVED

Study Officials

  • Muhammad Khan, MSAPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

March 16, 2021

Study Start

April 1, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)