- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887349
Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kırşehir, Turkey (Türkiye), 40100
- Kırşehir Ahi Evran University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control 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.
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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. |
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Experimental: Intervention group
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.
Additionally, Robacado exercises (jaw exercises) will be given to the individuals in this group.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Disability level
Time Frame: 6 week
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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.
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6 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain assessment
Time Frame: 6 week
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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.
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6 week
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Joint Range of Motion assessment
Time Frame: 6 week
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Cervical region flexion, extension, right-left rotation and right-left lateral flexion range of motion of individuals will be evaluated with clinical goniometer.
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6 week
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Proprioception assessment
Time Frame: 6 week
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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
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6 week
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Balance
Time Frame: 6 week
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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).
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6 week
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Muscle endurance
Time Frame: 6 week
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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.
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6 week
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Pain threshold and tolerance
Time Frame: 6 week
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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.
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6 week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43834581758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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