- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06926738
Effect of Upper Thoracic Manipulation on Neck Pain and Selected Muscle Activities
Effect of Upper Thoracic Spine Manipulation on Cervical Symptoms and Selected Muscle Activities in Chronic Mechanical Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt, 12611
- CairoU
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Giza, Egypt, 12611
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male and female subjects diagnosed and classified as having chronic non-specific NP with mobility disorders based on clinical guidelines of NP:
- Having NP for at least 3 months that may be associated with referred shoulder or upper extremity pain (Blanpied et al., 2017; Erdem et al., 2021; Puntumetakul et al., 2015).
- Present with a limitation of cervical ROM and their pain can be provoked by sustained end-range spinal movements or positions will be included (Blanpied et al., 2017).
- Patients present with unilateral or bilateral symptoms will be included (Blanpied et al., 2017; Yang et al., 2015).
- Age between 18-40 (J. Dunning & Rushton, 2009)
- Negative four tests of the Wainner cluster to exclude NP with radiating pain (Wainner et al., 2003).
- Hypomobility of at least one of the upper thoracic vertebrae (T1-T4) during segmental mobility assessment (Ssavedra-Hernández et al., 2011).
Exclusion Criteria:
- Subjects diagnosed as cervical radiculopathy or myelopathy (Ssavedra-Hernández et al., 2011).
- A history of whiplash injury, past cervical or thoracic surgery, rheumatoid arthritis, spinal fracture, heart disease, a recent significant trauma, and meningitis (Joshi et al., 2020; Puntumetakul et al., 2015).
- The presence of contraindications of spinal manipulation as spinal infection and spinal osteoporosis(Ssavedra-Hernández et al., 2011).
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 |
|---|---|
|
Experimental: Upper thoracic manipulation group
The Patients in this group will receive Upper Thoracic Manipulation.
|
Segmental mobility will be assessed using posteroanterior central vertebral pressure and posteroanterior unilateral vertebral pressure. It will be done while the patient lies in a prone position and the examiner stands at the level of the patient's head. Afterwards, the subjects in the thoracic manipulation group will be asked to lie in a prone position on a standard examination table and they were marked on both sides of the zygapophyseal joint of the selected segments including levels from T1- T4. Subjects will then be instructed to perform deep inhalation and exhalation and at the end of exhalation, the Clinician will perform thoracic manipulation (screw thrust technique) at the selected segmental level/s. This maneuver will be repeated for a maximum of two attempts in case of no hearing of a pop sound. It will be performed by an experienced physiotherapist with more than 10-year experience. |
|
Sham Comparator: Sham Upper Thoracic Manipulation
The patients in this group will receive the sham upper thoracic manipulation.
|
Segmental mobility will be assessed using posteroanterior central vertebral pressure and posteroanterior unilateral vertebral pressure. It will be done while the patient lies in a prone position and the examiner stands at the level of the patient's head. Afterwards, the subjects in the thoracic manipulation group will be asked to lie in a prone position on a standard examination table and they were marked on both sides of the zygapophyseal joint of the selected segments including levels from T1- T4. Subjects will then be instructed to perform deep inhalation and exhalation and at the end of exhalation, the Clinician will just the place the hands on the selected levels in the same hand placement of Thoracic manipulation group (screw thrust technique) without applying the manipulation. It will be performed by an experienced physiotherapist with more than 10-year experience. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity
Time Frame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
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A hard copy of the Visual analogue scale will be given to the patient who will be asked to mark a perpendicular line between the two borders of the scale to express his/her pain level. It will be measured pre-treatment, post-treatment, and each week for 2 weeks. The level of pain will be measured at the end range of active extension. |
Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion
Time Frame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
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The cervical ROM measurements will be performed with the participants sitting on a chair with instructions to sit in an upright posture. Prior to starting measurement, the patient will be asked to do these movements 5 times in each direction for familiarization and as a warm-up. The participant will sit erect with the thoracic spine away from the back of the chair, arms hanging at the sides, and feet flat on the floor. The participants were instructed to stare at a spot marked on a wall in front of them. Flexion, Extension, right and left side bending and rotation will be measured. Each measurement will be repeated for total three times. |
Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
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Sternocleidomastoid muscle activity
Time Frame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
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Regarding EMG measurement of the sternocleidomastoid, the electrodes will be positioned over the sternocleidomastoid muscle at half the distance between the mastoid process of the temporal bone and the jugular notch of the sternum, slightly posterior to the center of the belly of the muscle, and parallel to the muscle fibers. The reference electrode will be attached to the proximal portion of the sternum with tape. Each participant will perform three 5-s MVIC for each muscle. Each subject will be asked to increase the force against the assessor's hand, reach the maximum effort, and hold it for EMG recording. The mean value of the three trials for the maximal contraction in each muscle will be taken. The patient will be supine lying and fully rested for the measurement of the SCM activity. To measure the MVIC of the Sternocleidomastoid muscle, the patient will be asked to flex the cervical spine against maximal resistance from the examiner on the forehead area while supine lying |
Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
|
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Upper trapezius muscle activity
Time Frame: Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
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The Patient will be sitting in a chair with erect posture, hands supported on the thighs, feet parallel and supported on the floor, and eyes open for measurement of the upper trapezius muscle activity. The active and the reference electrodes will be placed 2 cm lateral to the midpoint between C7 and posterior acromion with 2 cm inter-electrode distance and ground placed on C7. Each participant will perform three 5-s MVIC for each muscle. Each subject will be asked to increase the force against the assessor's hand, reach the maximum effort, and hold it for EMG recording. The mean value of the three trials for the maximal contraction in each muscle was taken as the MVIC. The rest time between each maximum contraction will be 30 seconds. To measure the MVIC of the upper trapezius muscle, the patient will be asked to abduct his/her shoulder to 90 degrees with the elbow fully extended against maximum resistance which will be applied superior to the elbow to resist abduction. |
Pre-intervention, Immediately Post-Intervention, One-week Post-intervention, Two-week post-intervention.
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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
- Upper thoracic manipulation
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
product manufactured in and exported from the U.S.
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