Clinical trial NCT04801212: The Effects of Lumbar Stabilization Exercises With and Without Jaw Movements in Non-specific Low Back Pain.
Official title: The Effects of Lumbar Stabilization Exercises With and Without Jaw Movements in Non-specific Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Core Stability
Jaw Movements
Temporomandibular Joint
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: At baseline
measure: Numeric Pain Rating Scale
timeFrame: At 6th weeks
measure: Numeric Pain Rating Scale
timeFrame: At 12th weeks
measure: Roland Morris Questionnaire (RMQ):
timeFrame: At baseline
measure: Roland Morris Questionnaire (RMQ):
timeFrame: At 6th weeks
measure: Roland Morris Questionnaire (RMQ):
timeFrame: At 12th weeks
measure: Pressure Biofeedback unit (PBU):
timeFrame: At baseline
measure: Pressure Biofeedback unit (PBU):
timeFrame: A 6th weeks
measure: Pressure Biofeedback unit (PBU):
timeFrame: At 12th weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Physical Medicine & Rehabilitation
state: SIndh
Study officials:
affiliation: University of Lahore
name: Muhammad Khan, MSAPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Adler SS, Beckers D, Buck M. PNF in Practice: An Illustrated Guide. New York, NY: Springer. 2007.
citation: Voss DE, Ionta MK, Myers BJ. Proprioceptive Neuromuscular Facilitation. Patterns and Techniques. Philadelphia, PA: Harper & Row Publishers. 1985.
citation: 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.
citation: 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.
citation: 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.
citation: 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.