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NCT Number: NCT04801212

The Effects of Lumbar Stabilization Exercises With and Without Jaw Movements in Non-specific Low Back Pain.

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.

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Key information

Conditions

Chronic Nonspecific Low Back Pain Core Stability Jaw Movements Temporomandibular Joint

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sindh Institute of Physical Medicine & Rehabilitation

Karachi, Sindh, 75400, Pakistan

About this study

A randomized experimental controlled trial will be carried out to compare the effectiveness of core stabilization exercises performed with and without jaw movements in the management of nonspecific chronic low back pain. A total of 80 male and female volunteers having subjects with chronic nonspecific low back pain will be recruited in this study. All subjects will be assessed for transverse abdominal muscle strength contraction, pain and disability using Pressure Biofeedback Unit (BPU), Numeric Pain Rating Scale (NPRS 0-10cm) and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively. The scores on the mentioned scales will be documented as per guidelines. After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling. Group 1 will perform core stability exercises alone; Group 2 will perform core stability exercises with teeth clenching This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM&R). The computer-generated random sampling technique will be used to allocate the participants into the study groups. Data will be analyzed using SPSS 22 and one-way repeated measure ANOVA will be applied to see the mean difference in the 2 groups. For pair-wise comparison, the Tukey test will be applied. For pain and disability scales Friedman's test will be applied to see the two scales' median differences.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • · 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.

Exclusion criteria

  • · 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.

Treatment and study plan

core stability exercises with teeth clenching

Other

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

Other

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.

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: At baseline

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

  2. Numeric Pain Rating Scale

    Time frame: At 6th weeks

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

  3. Numeric Pain Rating Scale

    Time frame: At 12th weeks

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

  4. Roland Morris Questionnaire (RMQ):

    Time frame: At baseline

    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.

  5. Roland Morris Questionnaire (RMQ):

    Time frame: At 6th weeks

    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.

  6. Roland Morris Questionnaire (RMQ):

    Time frame: At 12th weeks

    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.

  7. Pressure Biofeedback unit (PBU):

    Time frame: At baseline

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

  8. Pressure Biofeedback unit (PBU):

    Time frame: A 6th weeks

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

  9. Pressure Biofeedback unit (PBU):

    Time frame: At 12th weeks

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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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