EVALUATION OF THE EFFECT OF OSTEOPATHIC TREATMENT ON CHRONIC NONSPECIFIC NECK PAIN
Phase: NA
Conditions: Nonspesific Neck Pain
Sponsor: Istanbul Rumeli University

Study Protocol Cover Page 
 
Document Title: Study Protocol 
Study Official Title: Evaluation of Osteopathic Treatment  in Adults with Nonspecific Neck 
Pain 
NCT Number:  
Date of Document: 12 November 2024 
Sponsor / Institution: Istanbul Rumeli University 
Confidentiality Statement: This document contains confidential information. Participants’ 
names or personal identifiers are not included. 
Brief Description: This study protocol describes a randomized, parallel-group interventional 
study comparing osteopathic treatment plus standard physical therapy versus standard 
physical therapy alone in adults with nonspecific neck pain. The protocol includes study 
objectives, eligibility criteria, interventions, outcome measures, and assessment schedule. The 
participants pain intensity (VAS), functional status (NDI), quality of life (SF-36), muscle 
strength, and cervical range of motion. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Statistical Cover Page 
 
Document Title: Statistical Analysis Plan 
Study Official Title: Evaluation of Osteopathic Treatment  in Adults with Nonspecific Neck 
Pain 
NCT Number:  
Date of Document: 12 November 2024 
Sponsor / Institution: Istanbul Rumeli University 
Confidentiality Statement: This document contains confidential information. Participants’ 
names or personal identifiers are not included. 
Brief Description: The Statistical Analysis Plan outlines the methods for analyzing the 
primary and secondary outcomes of the study, including pain intensity (measured using the 
Visual Analog Scale, VAS), functional status (assessed using the Neck Disability Index, NDI), 
quality of life (evaluated using the Short Form-36, SF-36), muscle strength, and cervical range 
of motion. The plan describes statistical tests, significance thresholds, handling of missing data, 
and subgroup analyses for the randomized, parallel-group design. The Shapiro–Wilk test will 
be used to test the normality of data distribution. A paired sample t-test and an independent 
sample t-test will be used. A p-value of less than 0.05 (p < 0.05) will be considered statistically 
significant for all analyses.