An observational study in Morbid Obesity Requiring Bariatric Surgery and Neck Pain Musculoskeletal, sponsored by Haydarpasa Numune Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Haydarpasa Numune Training and Research Hospital · Observational
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.
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.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
This study's planned enrollment of 25 is below the median of 106 across 206 observational studies indexed under Weight Loss.
Browse Weight Loss studies →Haydarpasa Numune Training and Research Hospital is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with obesity who are scheduled to undergo laparoscopic sleeve gastrectomy based on routine clinical indications. Participants will be evaluated before surgery and at 3, 6, and 12 months after surgery to assess changes in cervical posture, neck pain, and cervical function. The decision to perform surgery and the surgical procedure will not be assigned or modified by the research protocol.
Procedure: Laparoscopic 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.
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 gastrectomy
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 gastrectomy
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 gastrectomy
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 gastrectomy
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 gastrectomy
Change in Cervical Proprioception
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.
Time frame: Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy
Change in Health-Related Quality of Life
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.
Time frame: Preoperative baseline and 3, 6, and 12 months after laparoscopic sleeve gastrectomy
Change in Radiographic Cervical Sagittal Alignment
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.
Time frame: Preoperative existing lateral cervical radiograph and 12 months after laparoscopic sleeve gastrectomy
Plan to share: No — Individual participant data will not be publicly shared because of participant confidentiality and institutional data-protection requirements.
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 86 non-industry observational studies under Weight Loss, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 99. This study's planned 10 months is below that.
Counting every sponsor, half of 92 studies reached it within 32 months; a quarter within 16 and three quarters within 99.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Sep 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Haydarpasa Numune Training and Research Hospital