Morbid Obesity Requiring Bariatric Surgery, Neck Pain Musculoskeletal
Conditions
Keywords
Laparoscopic Sleeve Gastrectomy, Bariatric Surgery, Cervical Posture, Cervical Sagittal Alignment, Cervical Function, Neck Disability Index, Cervical Lordosis, Cervical Range of Motion, Weight Loss, Cervical Muscle Strength, Cervical Proprioception, Joint Position Error, Cervical Muscle Endurance
Brief summary
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.
Detailed description
Obesity may affect the cervical spine through increased mechanical loading, anterior displacement of the body's center of gravity, postural adaptations, systemic inflammation, and impaired cervical muscle function. Although improvements in low back pain and other musculoskeletal symptoms have been reported following bariatric surgery, prospective evidence regarding cervical posture, neck pain, and cervical function after laparoscopic sleeve gastrectomy remains limited. This is a prospective, single-center study involving adults with obesity who have been scheduled to undergo laparoscopic sleeve gastrectomy based on routine clinical indications. The decision to perform surgery will be made independently of the research protocol. The study will not alter the surgical procedure or assign any experimental drug, treatment, or device. Approximately 25 participants will be enrolled, with the aim of obtaining at least 20 participants who complete the study follow-up. Assessments will be performed before surgery and at 3, 6, and 12 months after surgery. Neck-related disability will be assessed using the Neck Disability Index. Neck pain intensity will be measured using a Visual Analog Scale or Numerical Rating Scale, and health-related quality of life will be evaluated using the 12-Item Short Form Health Survey. Cervical range of motion will be measured with an inclinometer. Isometric cervical muscle strength will be assessed using a MicroFET3 handheld dynamometer. Cervical muscle endurance will be evaluated using the craniocervical flexion test with a pressure biofeedback stabilizer, together with cervical flexor and extensor endurance tests. Cervical proprioception will be assessed using a laser-based joint position error test. Only participants with an existing lateral cervical radiograph obtained before study enrollment for a reason unrelated to the research will be eligible. No additional preoperative cervical radiograph will be obtained solely for the study. At the 12-month follow-up, one lateral cervical radiograph will be obtained to assess cervical sagittal alignment. The C2-C7 Cobb lordosis angle and C2-C7 sagittal vertical axis will be measured using standardized digital measurement methods by the same radiologist. The primary analysis will evaluate changes in Neck Disability Index scores across the scheduled study visits. Secondary analyses will evaluate changes in neck pain intensity, cervical range of motion, cervical muscle strength, cervical muscle endurance, proprioception, quality of life, and radiographic cervical alignment. Associations between the amount of weight loss and changes in cervical pain, posture, and function will also be explored.
Interventions
PROCEDURELaparoscopic Sleeve Gastrectomy
Laparoscopic 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.
Sponsors
Haydarpasa Numune Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Willingness and ability to attend the preoperative and 3-, 6-, and 12-month follow-up assessments * Provision of written informed consent
Exclusion criteria
* 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 * Malignancy or advanced systemic disease, such as advanced heart failure or renal failure * Pregnancy or breastfeeding * Inability to attend the scheduled follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neck Disability Index (NDI) Score | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neck Pain Intensity at Rest and During Activity | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | 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. |
| Change in Cervical Range of Motion | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | 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. |
| Change in Cervical Muscle Strength | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | 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. |
| Change in Cervical Muscle Endurance | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | 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. |
| Change in Cervical Proprioception | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | Cervical proprioception will be assessed using a Joint Position Error test. Repositioning error will be recorded in degrees at each scheduled assessment. Changes in Joint Position Error measurements across the study visits will be analyzed. Lower values indicate more accurate cervical repositioning and better proprioceptive performance. |
| Change in Health-Related Quality of Life | Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy | Health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The Physical Component Summary and Mental Component Summary scores will be calculated and analyzed separately at each scheduled assessment. Higher scores indicate better health-related quality of life. Changes in both component scores across the study visits will be analyzed. |
| Change in Radiographic Cervical Sagittal Alignment | Preoperative existing lateral cervical radiograph and 12 months after laparoscopic sleeve gastrectomy | adiographic cervical sagittal alignment will be evaluated on lateral cervical radiographs using the C2-C7 Cobb lordosis angle and the C2-C7 sagittal vertical axis. The C2-C7 Cobb lordosis angle will be measured in degrees, and the C2-C7 sagittal vertical axis will be measured as a linear distance in millimeters. Both parameters will be measured separately using standardized digital measurement tools by the same radiologist. Changes from the preoperative radiograph to the 12-month postoperative radiograph will be analyzed separately for each parameter. |
Countries
Turkey (Türkiye)
Contacts
CONTACTKubra Neslihan Kurt Oktay, MD
Outcome results
None listed