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

NCT04317937 | Completed

• 1 other identifier: 013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; PHYSIOTHERAPY; JAW

Outcome Measures

Primary Outcomes (4)

• Numeric Pain Rating scale (NPRS)

  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.

  Week 6

• Neck disability Index (NDI)

  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.

  Week 6

• Neck Proprioception test

  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/Starting position using a cervical spine range of motion device.

  Week 6

• Neck muscles endurance test

  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.

  Week 6

Study Arms (2)

Jaw Movement Group

EXPERIMENTAL

A: Jaw opening-closing movements * Active jaw movements * Active neck exercises 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; Other: Exercise Therapy; Other: Supportive Treatment

Exercise therapy

ACTIVE COMPARATOR

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; Other: Exercise Therapy; Other: Supportive Treatment

Interventions

Jaw opening-closing movements OTHER

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 15 times. 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).

Also known as: Jaw movements

Jaw Movement Group

Specific Active exercises OTHER

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 15 times. 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.

Also known as: Active neck exercises

Exercise therapy

Exercise Therapy OTHER

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.

Also known as: Isometric neck exercises

Exercise therapy; Jaw Movement Group

Supportive Treatment OTHER

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.

Also known as: Postural Advice and Home Exercise Program with Dairy

Exercise therapy; Jaw Movement Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Insititute of Physical Medicine & Rehabilitation

Karachi, Sindh, Pakistan

Location

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MeSH Terms

Conditions

Neck Pain

Interventions

Exercise Therapy; Palliative Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Saeed Akhter, MS

  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: March 6, 2020
• First Posted: March 23, 2020
• Study Start: November 15, 2018
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)