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

Primary Purpose

Chronic Nonspecific Low Back Pain, Core Stability, Jaw Movements

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
core stability exercises with teeth clenching
core stability exercises
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sindh Institute of Physical Medicine & Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

core stability exercises with teeth clenching

core stability exercises alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2021
Last Updated
May 3, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT04801212
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain, Core Stability, Jaw Movements, Temporomandibular Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
core stability exercises with teeth clenching
Arm Type
Experimental
Arm Description
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.
Arm Title
core stability exercises alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
core stability exercises with teeth clenching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
core stability exercises
Intervention Description
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 Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Time Frame
At baseline
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Time Frame
At 6th weeks
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases.
Time Frame
At 12th weeks
Title
Roland Morris Questionnaire (RMQ):
Description
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.
Time Frame
At baseline
Title
Roland Morris Questionnaire (RMQ):
Description
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.
Time Frame
At 6th weeks
Title
Roland Morris Questionnaire (RMQ):
Description
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.
Time Frame
At 12th weeks
Title
Pressure Biofeedback unit (PBU):
Description
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Time Frame
At baseline
Title
Pressure Biofeedback unit (PBU):
Description
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Time Frame
A 6th weeks
Title
Pressure Biofeedback unit (PBU):
Description
Pressure Biofeedback unit (PBU) PBU is a reliable and valid tool for recording core stability muscle strength .
Time Frame
At 12th weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Khan, MSAPT
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sindh Institute of Physical Medicine & Rehabilitation
City
Karachi
State/Province
SIndh
ZIP/Postal Code
75400
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20434958
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.
Results Reference
background
PubMed Identifier
23314589
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.
Results Reference
background
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.
Results Reference
background
Citation
Adler SS, Beckers D, Buck M. PNF in Practice: An Illustrated Guide. New York, NY: Springer. 2007.
Results Reference
background
Citation
Voss DE, Ionta MK, Myers BJ. Proprioceptive Neuromuscular Facilitation. Patterns and Techniques. Philadelphia, PA: Harper & Row Publishers. 1985.
Results Reference
background
PubMed Identifier
12981197
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.
Results Reference
background
PubMed Identifier
10784335
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.
Results Reference
background
PubMed Identifier
10869479
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.
Results Reference
background
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.
Results Reference
background

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

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