Changes in Cervical Posture, Cervical Function, and Neck Pain After Sleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHaydarpasa Numune Training and Research Hospital
About this trial
Obesity may contribute to neck pain, altered cervical posture, and impaired cervical function through increased mechanical loading, changes in body alignment, and reduced muscle performance. Although laparoscopic sleeve gastrectomy can produce substantial weight loss, its effects on cervical posture and neck-related function have not been studied comprehensively.
This prospective, single-center study will include approximately 25 adults who are already scheduled to undergo laparoscopic sleeve gastrectomy as part of their routine clinical care. The decision to perform surgery and the surgical procedure itself will not be assigned or modified by the study. Participants will be evaluated before surgery and at 3, 6, and 12 months after surgery.
Study assessments will include neck-related disability, neck pain intensity, quality of life, cervical range of motion, cervical muscle strength and endurance, and cervical joint position sense. Existing preoperative lateral cervical radiographs will be reviewed, and a lateral cervical radiograph will be obtained at the 12-month follow-up to assess cervical spinal alignment.
The primary outcome will be the change in Neck Disability Index scores across the scheduled study assessments. The study aims to determine whether weight loss following laparoscopic sleeve gastrectomy is associated with changes in cervical posture, neck pain, and cervical function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years
Obesity with a clinical indication for bariatric surgery
Scheduled to undergo laparoscopic sleeve gastrectomy at Haydarpasa Numune Training and Research Hospital
Availability of a previously obtained lateral cervical radiograph in the hospital information system or national electronic health record
Disqualifiers
Previous cervical spine surgery
Acute cervical trauma, cervical fracture, or severe cervical deformity
Diagnosed inflammatory rheumatic disease, such as rheumatoid arthritis or ankylosing spondylitis
History of a neurological disorder, such as multiple sclerosis, myopathy, or peripheral neuropathy
Trial population
The study population will consist of adults with obesity who have been scheduled to undergo laparoscopic sleeve gastrectomy based on routine clinical indications at the Bariatric Surgery Unit of Haydarpasa Numune Training and Research Hospital. Eligible patients must have a previously obtained lateral cervical radiograph available in the hospital information system or national electronic health record.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic Sleeve Gastrectomy
Procedure/SurgeryLaparoscopic sleeve gastrectomy will be performed by the bariatric surgery team according to routine clinical indications and standard institutional practice. The decision to perform surgery, the surgical technique, and perioperative management will not be assigned or modified by the study protocol. The study will prospectively assess changes in cervical posture, neck pain, cervical disability, and cervical function following the procedure.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Participants Undergoing Laparoscopic Sleeve Gastrectomy1 intervention
Trial outcomes
Primary outcomes
1
Change in Neck Disability Index (NDI) Score
The Neck Disability Index is a 10-item self-reported questionnaire used to assess neck-related disability. Each item is scored from 0 to 5, resulting in a total score ranging from 0 to 50, with higher scores indicating greater disability. Neck Disability Index scores will be recorded at the preoperative baseline assessment and at the scheduled postoperative follow-up visits. Changes in scores across the study assessments will be analyzed.
Time frame
Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomySecondary outcomes
1
Change in Neck Pain Intensity at Rest and During Activity
Neck pain intensity at rest and during activity will be assessed separately using an 11-point Numerical Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will provide separate ratings for resting neck pain and activity-related neck pain at each scheduled assessment. Changes in the two scores across the study visits will be analyzed separately, with lower scores indicating less pain.
Time frame
Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy2
Change in Cervical Range of Motion
Cervical range of motion will be measured in degrees using an inclinometer. Measurements will include cervical flexion, extension, right and left lateral flexion, and right and left rotation. Each movement direction will be recorded and analyzed separately at the scheduled study assessments. Higher values indicate a greater range of motion. Changes in each cervical range-of-motion measurement across the study visits will be analyzed.
Time frame
Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy3
Change in Cervical Muscle Strength
Cervical muscle strength will be assessed using a MicroFET3 handheld dynamometer and recorded in newtons. Maximal isometric strength of the cervical flexor and extensor muscles will be measured separately at each scheduled assessment. Changes in flexor and extensor strength across the study visits will be analyzed separately. Higher values indicate greater cervical muscle strength.
Time frame
Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy4
Change in Cervical Muscle Endurance
Cervical muscle endurance will be assessed using the craniocervical flexion test with a pressure biofeedback device and a timed cervical extensor endurance test. Flexor and extensor endurance results will be recorded in seconds and analyzed separately at each scheduled assessment. Higher values indicate greater cervical muscle endurance.
Time frame
Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomySponsors and contacts
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Source ClinicalTrials.gov