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Trial record 2 of 17 for:    ADVISE II

The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction

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ClinicalTrials.gov Identifier: NCT04317937
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Saeed Akhter, University of Lahore

Brief Summary:
The study will be focused on non- specific chronic neck pain patients. The primary objective is to study the effects of jaw sensorimotor system in the treatment of patients with neck pain and dysfunction. It will be randomized controlled trail with the estimated sample size of 80 with both genders. The experimental group will be performed Jaw opening-closing movements with active neck flexion and extension movements and control group will be performed active neck flexion and extension movements. Both groups will be received isometric strengthening exercises, Postural Advice and Home Exercise Program with Dairy. Numeric Pain Rating scale (NPRS), Neck disability Index (NDI), Neck Proprioception tests and Neck muscles endurance test will be used as outcome measures at day 0 and week 6 for treatment effect in both groups. Tables and graphs will used for demographic descriptions and appropriate statistical tests will be applied to establish treatment effect within and between groups.

Condition or disease Intervention/treatment Phase
Neck Pain PHYSIOTHERAPY JAW Other: Jaw opening-closing movements Other: Specific Active exercises Other: Exercise Therapy Other: Supportive Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Jaw Movement Group

A: Jaw opening-closing movements

  • Active jaw movements
  • Active neck exercises
  • Head-Neck extension on jaw opening (Mandible moves vertically downward);

B: Isometric strengthening exercises (Same as control group) C: Postural Advice and Home Exercise Program with Dairy (Same as control group)

Other: Jaw opening-closing movements

Jaw opening-closing movements Patient seated on a normal standard comfortable chair with proper back support and feet placed on the floor with no head support.

Active jaw movements The patient will then perform maximal Jaw opening-closing movements at a pace convenient for his/her for one minute. Three sets with two minutes rest in between will be ensured.

Active neck exercises While performing the above movements of jaws, the patient will actively perform active neck exercise (head-neck movements in sagittal plane- Extension- Flexion).

Head-Neck extension on jaw opening (Mandible moves vertically downward); and then from Head-Neck extension to natural flexion movement on jaw closing (Mandible moves vertically upward).

Other Name: Jaw movements

Other: Exercise Therapy

Isometric strengthening exercises For flexion the starting position will be upright head and neck. The patient will be asked to hold this position.

For extension the starting position will be upright head and neck. The patient will be asked to hold this position.

For rotation the starting position will be upright head and neck. The patient will be asked to hold this position.

• In all above movements ( flexion, extension & rotation) following method will be followed: Manual resistance will then be applied by the investigator by placing the hand on the patient's forehead, posterior part of the head and lateral part of the head with 6 second hold. 15 repetitions of this exercise will be performed. Three sets with one minute rest in between will be ensured.

Other Name: Isometric neck exercises

Other: Supportive Treatment

Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise program. Postural Advise Maintain upright posture while sitting.

  • Avoid prolonged neck bending.
  • Avoid twisting movement of the neck.
  • Use a suitable pillow to maintain cervical spine.
  • Adjust computer screen at eye level.
  • Avoid constant use of mobile or similar device to prevent excessive strain over neck joints and muscles.
  • Carry light and even weight in both hands while shopping and other chores.•Stay hydrated.

Home Exercise Program (unsupervised) (3 times a day)

  • Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15
  • Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15
  • Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15
  • Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15

Home Dairy A home dairy will be provided to maintain home exercise program record.

Other Name: Postural Advice and Home Exercise Program with Dairy

Active Comparator: Exercise therapy

A: Active neck exercises Active neck exercises Active jaw movements (Active Jaw movement will not be perform in this group) B: Isometric strengthening exercises C: Postural Advice and Home Exercise Program with Dairy i: Postural Advise ii: Home Exercise Program (unsupervised) iii: Home Dairy

Frequency and Duration of Treatment Non-specific Chronic Neck Pain (more than 3 months history of pain)

Initial Assessment (week 1) 60 minutes First treatment session (week1) 40 minutes

  • 3 treatment sessions per week (week- 2) 40 minutes
  • 3 treatment sessions per week (week- 3) 40 minutes
  • 3 treatment sessions per week (week- 4) 40 minutes
  • 3 treatment sessions per week (week- 5) 40 minutes
  • Last treatment session (week 6) 40 minutes
  • Final Assessment (week 6) 60 minutes
Other: Specific Active exercises

Active neck exercises:

Patient seated on a normal standard comfortable chair with proper back support and feet placed on the floor with no head support.

Note: For Active neck exercise (flexion and extension movements of neck), firstly the patient will perform maximal Jaw opening-closing movements at a pace convenient for his/her for 5 times in order to observe (eyeball observation) the neck extension and flexion as reference point for each individual.

Using this reference points, the patient will ask perform below mentioned active neck exercise.

Active neck exercises: The patient will then perform active neck exercise (flexion and extension of neck) at a pace convenient for his/her for one minute. Three sets with two minutes rest in between will be ensured.

Active jaw movement: While performing the above movements of neck, the patient will not perform any jaws movements.

Other Name: Active neck exercises

Other: Exercise Therapy

Isometric strengthening exercises For flexion the starting position will be upright head and neck. The patient will be asked to hold this position.

For extension the starting position will be upright head and neck. The patient will be asked to hold this position.

For rotation the starting position will be upright head and neck. The patient will be asked to hold this position.

• In all above movements ( flexion, extension & rotation) following method will be followed: Manual resistance will then be applied by the investigator by placing the hand on the patient's forehead, posterior part of the head and lateral part of the head with 6 second hold. 15 repetitions of this exercise will be performed. Three sets with one minute rest in between will be ensured.

Other Name: Isometric neck exercises

Other: Supportive Treatment

Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise program. Postural Advise Maintain upright posture while sitting.

  • Avoid prolonged neck bending.
  • Avoid twisting movement of the neck.
  • Use a suitable pillow to maintain cervical spine.
  • Adjust computer screen at eye level.
  • Avoid constant use of mobile or similar device to prevent excessive strain over neck joints and muscles.
  • Carry light and even weight in both hands while shopping and other chores.•Stay hydrated.

Home Exercise Program (unsupervised) (3 times a day)

  • Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15
  • Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15
  • Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15
  • Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15

Home Dairy A home dairy will be provided to maintain home exercise program record.

Other Name: Postural Advice and Home Exercise Program with Dairy




Primary Outcome Measures :
  1. Numeric Pain Rating scale (NPRS) [ Time Frame: Week 6 ]

    Assessing the change in pain level:

    The subject will be graphically or verbally portrayed a simple depiction consisting of a horizontal bar with labels ranging from '0' to '10' (a total of 11 integers)to rate his pain intensity.'0' would be considered as 'no pain'and '10' would indicate worst pain imaginable, whereas values 1 to 3 would indicate mild pain; 4 to 6 as moderate pain and 7 to 10 would indicate severe pain. NPRS has shown to have good sensitivity and it yields data that are best suited for statistical analysis.


  2. Neck disability Index (NDI) [ Time Frame: Week 6 ]

    Assessing the change in neck disability level:

    The Neck Disability Scale is a reliable outcome measure to assess the treatment effectiveness for neck disability. It consists of 10 components.


  3. Neck Proprioception test [ Time Frame: Week 6 ]

    Assessing the change in neck preconception error:

    The concept adopted from Hallgren and co workers and it will be used as research instrument on baseline and final visits to find out any proprioceptive errors.

    A Neutral Reference Point (NRP) will be used and asking patient to perform cervical spine range of motion (rotation, flexion and extension). Then measures any overshoot or undershoot of movement with regard to NRP using a cervical spine range of motion device.


  4. Neck muscles endurance test [ Time Frame: Week 6 ]

    Assessing the change in neck muscle endurance level:

    Neck flexor muscle endurance test will be used to measure neck endurance in this study. It is a simple test and easy to apply. It is reliable test and achieved interrater reliability at moderate level among neck pain population.

    Cervical extensor endurance test is a simple test for measurement neck extensor muscles endurance. It has good inter-rater reliability Kappa =0.800, Kappa SE= 0.109, 95% CL) and easy to administer. Losing of chin tuck position from neutral position of cervical spine is indicating of global weakness of neck muscles (weakness of superficial and deep neck extensor muscles) whist increasing of chin length with neck extension indicates a over activity of superficial extensor muscles and weakness of deep extensor muscles of cervical spine.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Both genders

    • 18 years to 50 years
    • Participants with history neck of more than 3 months with no related conditions
    • Non radiating pain to arms
    • Diagnosed as Nonspecific Chronic Neck pain by consultants
    • NPRS-Numeric Pain Rating Scale: score 3 to 8 (Score 3 Ending of mild pain, Score 8 Beginning of worst pain)
    • NDI- Neck Disability Index: score 5 to 34 (5 to 14 Mild disability,15- 24 Moderate disability & 25 to 34 Severity disability)
    • No TMJ pain or dysfunction

Exclusion Criteria:

  • • NPRS-Numeric Pain Rating Scale: Score 1 & 2 and score 9 & 10 (Score 1 & 2 mild pain and Score 9 & 10 worst pain)

    • NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to 50(Complete disability)
    • Specific or nonspecific Acute Neck pain (Less than 7 days)
    • Neck pain- Specific or nonspecific Subacute( pain history more than seven days however less than three months)
    • Neck pain- Specific Chronic (pain history more than 3 months)
    • TMJ Dysfunction
    • WAD (Whiplash Associated Disorders)
    • Cervical spondylosis
    • Rheumatoid arthritis
    • Instability of spine
    • Facial injury or dental infection
    • Any type of infection of body
    • Neck or spinal segment fracture
    • Spinal tumor or any type of tumor/cancer
    • Unexplained headache
    • Post cervical spine surgical cases
    • Signs and symptoms of Cervical spine stenosis
    • Signs and symptoms of disc bulge or herniation of cervical spine
    • Radiating neck pain or Radiculopathy of cervical spine
    • Cognitive impairment
    • Neurological conditions (MS/PD/CVA/MND)
    • Application of injection therapy in cervical spine
    • Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack, Dizziness, Double vision, Gait disturbance)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317937


Contacts
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Contact: Saeed Akhter, MS +923312049179 saeed787@hotmail.com

Locations
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Pakistan
Insititute of Physical Medicine & Rehabilitation Recruiting
Karachi, Sindh, Pakistan
Contact: Saeed Akhter, MS    +923312049179    saeed787@hotmail.com   
Sponsors and Collaborators
University of Lahore
Investigators
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Principal Investigator: Saeed Akhter, MS University of Lahore
Publications:
Sharmila B. Isometric muscle energy technique and non-specific neck pain in secondary school teachers-Results of an experimental study.Indian J Physiother Occup Ther. 2014;8(2):58.
Dubner R, Ren K, Sessle BJ. Sensory mechanisms of orofacial pain: Intreatment of TMDs: Bridging the Gap. Pain. 2013;154:511-14.
McLoon LK, Andrade F. Craniofacial muscles: A new framework for understanding the effector side of craniofacial muscle control. Springer Science & Business Media. 2013:111-30.
Sowmya MV. Isometric neck exercises versus dynamic neck exercises in chronic neck pain. 2014;3(2):32-43
Pöntinen PJ. Reliability, validity, reproducibility of algometry in diagnosis of active and latent tender spots and trigger points. J Musculoskelet Pain. 1998;6(1):61-71.
Zar JH. Biostatistical Analysis. 4th ed. New Jersey: Pearson; 2010.

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Responsible Party: Saeed Akhter, principal investigator, University of Lahore
ClinicalTrials.gov Identifier: NCT04317937    
Other Study ID Numbers: 013
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations