Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05887349
• Other study ID #: 43834581758
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: Kirsehir Ahi Evran Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nerve compression, disc herniation, and fracture-related factors may play a role in the etiology of chronic neck pain, or the pain may not be associated with a specific cause. In the cervical region, muscles, fascia, disc, nerve root and facet joints are the structures that carry pain. Problems related to these structures can also cause pain in the cervical region and shoulder, arm, interscapular region and craniocervical structures. The stomatognathic system is the integrity of the structures that perform the functions of chewing, swallowing and speaking. This system in the head and neck region; It consists of bones, muscles, joints, ligaments, teeth, supporting dental tissues, glands, tongue, mouth and surrounding tissues, and neuromuscular system. The relationship between the stomatognathic and craniocervical systems is demonstrated by the interaction between masticatory and cervical muscles. Wiesinger et al. examined the relationship between spinal pain and temporamandibular joint disorders in a large sample and stated that both conditions may share common risk factors or affect each other. The coexistence of cervical spine and temporomandibular joint pathologies (TMJ) is explained by the neuroanatomical convergence of nociceptive neurons receiving trigeminal and neck sensory inputs. Studies have shown that neck disability may be accompanied by jaw joint disability, masseter myofascial pain, and regional muscle tenderness. Olivio et al. He reported that the treatment of individuals with TMJ pathology should also focus on the neck region, because improvement of one may affect the other. Based on this idea, Calixtre et al. reported that they achieved positive improvements in pain and jaw functions in their study investigating the effects of cervical region mobilization and exercises on individuals with TMJ.

Description:

Nerve compression, disc herniation, and fracture-related factors may play a role in the etiology of chronic neck pain, or the pain may not be associated with a specific cause. In the cervical region, muscles, fascia, disc, nerve root and facet joints are the structures that carry pain. Problems related to these structures can also cause pain in the cervical region and shoulder, arm, interscapular region and craniocervical structures. The stomatognathic system is the integrity of the structures that perform the functions of chewing, swallowing and speaking. This system in the head and neck region; It consists of bones, muscles, joints, ligaments, teeth, supporting dental tissues, glands, tongue, mouth and surrounding tissues, and neuromuscular system. The relationship between the stomatognathic and craniocervical systems is demonstrated by the interaction between masticatory and cervical muscles. Wiesinger et al. examined the relationship between spinal pain and temporamandibular joint disorders in a large sample and stated that both conditions may share common risk factors or affect each other. The coexistence of cervical spine and temporomandibular joint pathologies (TMJ) is explained by the neuroanatomical convergence of nociceptive neurons receiving trigeminal and neck sensory inputs. Studies have shown that neck disability may be accompanied by jaw joint disability, masseter myofascial pain, and regional muscle tenderness. Olivio et al. He reported that the treatment of individuals with TMJ pathology should also focus on the neck region, because improvement of one may affect the other. Based on this idea, Calixtre et al. reported that they achieved positive improvements in pain and jaw functions in their study investigating the effects of cervical region mobilization and exercises on individuals with TMJ. In the treatment of chronic neck pain, it has been shown that craniocervical flexion exercise, cervical stabilization and endurance exercises, aerobic exercises, proprioceptive exercises and patient education, especially strengthening exercises for deep and superficial flexor muscles, reduce pain and improve quality of life by increasing muscle strength and functions. In the literature, the number of studies investigating the effectiveness of an exercise program for the jaw joint in individuals with chronic neck pain is quite limited. In this context, our aim is to investigate the effects of Rocabado exercises, one of the jaw joint exercises, on pain, pain threshold/tolerance, range of motion, proprioception, disability, quality of life, muscle strength, muscle endurance, sleep quality and posture in individuals with chronic neck pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 20, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Being between the ages of 18-65
• Having neck pain for 3 months,
• Being sedentary
• Not participating in any physical therapy program in the last 6 months.

Exclusion Criteria:

• Being history of previous spinal surgery or trauma,
• Beingneurological deficit, vestibular pathology, neurological, cardiopulmonary, musculoskeletal problems affecting physical performance
• Being any pathology in the shoulder joint, any pathology in the jaw joint, and pregnancy were determined.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Neck Stabilization Exercise
1. Control Group exercise program (Cervical Stabilization exercises group) The patients in the control group will be given cervical stabilization exercises consisting of 3 levels and increasing difficulty. The exercises will be taught to the patients level by level by the physiotherapist for 6 weeks. The subjects will perform the exercises for a total of 6 weeks. Before each exercise session, stretching exercises will be performed on the subjects.
• Neck Stabilization Exercise + Rocabado Exercises
2. Intervention group exercise program (the group to which Robacado exercises will be added in addition to cervical stabilization exercises) The exercises to be applied to the control group for 6 weeks will be given to the intervention group in the same order and at weekly intervals. In addition, individuals in this group will be given Robacado exercises. Robacado exercises: Resting position for the tongue: The tip of the tongue is placed on the upper palate, just behind the front teeth (resting position for the tongue). When the body is in an upright position, scapular retraction and depression movements are performed without disturbing the position of the cervical region. When the body is in an upright position, at C2-C7 levels, hands are clamped on the neck and cranio-cervical flexion is studied.

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University	Kirsehir

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Visual Analog Scale (VAS) will be used for the presence and severity of neck pain in the individuals included in the study. Each participant will be asked about the presence and severity of pain at the beginning and end of the study and recorded. For VAS, individuals are asked to indicate the degree of pain they have on the VAS scale, numbered from 0 to 10 on a straight line, with "0" being no pain and "10" being the most severe pain and recorded.	6 week
Secondary	Joint Range of Motion assessment	Cervical region flexion, extension, right-left rotation and right-left lateral flexion range of motion of individuals will be evaluated with clinical goniometer.	6 week
Secondary	Proprioception assessment	The Cervical Joint Position Error Test (CJPET) is used to evaluate cervical region proprioception. CJPET assesses cervical proprioception in four positions (flexion, extension, left rotation, and right rotation). It is based on the principle of finding a point while the eyes are closed. 10 repetitions for each position were done. The first four measurements are trials and the average of the last six measurements gives us the joint position error	6 week
Secondary	Balance	Participants' static and dynamic balance was assessed using the Biodex balance system (Biodex, Inc., Shirley, New York). The device consists of a mobile balance platform that provides quantitative measurements of postural control in the sagittal and frontal planes in a 360° arc of motion up to 20° surface inclination. The device evaluates anterior-posterior stability index (A-P), medial-lateral stability index (M-L), and overall stability index (overall variance in both planes).	6 week
Secondary	Posture	The posture of the participants was evaluated with the "New York Posture Analysis (NYPA). NYPA evaluates postural changes through observation of 13 separate body parts. After observation, five (5) points are given if the posture of the body parts is correct, three (3) points are given if the posture is moderately impaired, and one (1) point is given if the posture is seriously impaired. The maximum score to be obtained from the test is 65, while the minimum score is 13.	6 week
Secondary	Disability level	Neck disability caused by neck pain was evaluated with the Neck Disability Index (NDI), which has been validated and reliable in Turkish. NDI was developed to evaluate the impact of neck pain on daily life activities (pain intensity, personal care, lifting, reading, concentration, work, driving, sleep and leisure activities) and consists of 10 sections. Each section is scored between 0 and 5 points. The total score obtained is between 0-50. Scores between 0-4 indicate no disability, scores between 5-14 indicate mild disability, scores between 15-24 indicate moderate disability, scores between 25-34 indicate severe disability, and scores above 35 indicate full disability.	6 week
Secondary	Muscle strength	Flexion and extension isometric muscle strength of the neck region was evaluated with a hand dynamometer (Lafayette Instrument Company, USA). The evaluation was performed based on the muscle testing positions and method described by Lovett. While evaluating flexion muscle strength, participants were asked to flex their heads while lying in a supine position and resistance was given from the frontal region. While evaluating extension muscle strength, participants were asked to extend their heads while lying in the prone position and resistance was given from the occipital region.	6 week
Secondary	Muscle endurance	The endurance of the cervical region flexor muscles was evaluated in the supine position, with the hands next to the body and in the hook position. Participants were asked to gently bring their chin closer to the chest area. The time it remained in this position was recorded in seconds. The evaluator placed his hand under the occiput to determine whether the position was maintained. The endurance of the cervical region extensor muscles was evaluated while the participant was in the prone position. The participant's head was positioned so that it hung over the bed and a 2 kg weight bag was tied to its head. The time he maintained this position was recorded in seconds.	6 week
Secondary	Pain threshold and tolerance	Participants' pain threshold and tolerance to pressure were evaluated using a digital algometer device (JTech Medical Industries, ZEVEX Company). It is stated that the reliability of this digital algometer is high. In the evaluation of pain threshold and tolerance, the midpoint of the upper part of the trapezius muscle between the 7th cervical vertebra and the acromion was taken as a reference. Evaluations were made with a 1 cm2 disc head apparatus connected to the algometer device that gives results in kg/cm2.	6 week