Comparative Effects of Connective Tissue Massage and Physical Modalities Added to Cervical and Scapulothoracic Stabilization Exercises on Pain, Function, and Endurance in Individuals With Chronic Neck Pain
Phase: NA
Conditions: Non-specific Neck Pain
Sponsor: Fenerbahce University

Study Protocol and Statistical Analysis Plan 
Document Title: Comparative Effects of Connective Tissue Massage and Physical Modalities 
Added to Cervical and Scapulothoracic Stabilization Exercises on Pain, Function, and Endurance 
in Individuals with Chronic Neck Pain  
NCT Number: NCTXXXXXXXX 
Document Date: April 13, 2022 
Study Protocol 
Study Design 
This study is a double-blinded, randomized controlled trial involving 51 individuals diagnosed 
with non-specific neck pain. Participants are randomly assigned to three groups. Group 1 
receives only exercises that focus on cervical and scapulothoracic stabilization. Group 2 
receives the same exercises in addition to connective tissue massage. Group 3 receives the same 
exercises along with electrotherapy consisting of infrared therapy, continuous ultrasound, and 
TENS applied to the painful area. 
Inclusion Criteria 
 Participants will be between 18 and 65 years of age, 
 They will present with non-specific chronic neck pain localized in the posterior cervical 
spine between the occipital region and the spinous process of the first thoracic vertebra, 
 They will be able to cooperate with the assessments required in the study. 
Exclusion Criteria 
 Neck pain resulting from trauma within the last 6 months 
 History of any surgical procedure related to a cervical spine disorder 
 Clinical signs of cervical radiculopathy and/or myelopathy 
 Inflammatory arthritis affecting the cervical spine 
 Tumors or infections involving the cervical spine 
 Vertebrobasilar artery insufficiency 
 Neurological disorders (e.g., multiple sclerosis, Parkinson’s disease, syringomyelia) 
 Congenital anomalies affecting the spine 
 Systemic diseases (e.g., diabetes mellitus) 
 Shoulder pathologies (e.g., tendinitis, bursitis, capsulitis) 
 

 
Neck pain resulting from trauma within the last 6 months 
 
History of any surgical procedure related to a cervical spine disorder 
 
Clinical signs of cervical radiculopathy and/or myelopathy 
 
Inflammatory arthritis affecting the cervical spine 
 
Tumors or infections involving the cervical spine 
 
Vertebrobasilar artery insufficiency 
 
Neurological disorders (e.g., multiple sclerosis, Parkinson’s disease, syringomyelia) 
 
Congenital anomalies affecting the spine 
 
Systemic diseases (e.g., diabetes mellitus) 
 
Shoulder pathologies (e.g., tendinitis, bursitis, capsulitis) 
Interventions 
Participants are randomly assigned to three groups. Group 1 receives only cervical and 
scapulothoracic stabilization exercises. Group 2 receives the same exercises in addition to 
connective tissue massage, starting from the primary regions and gradually extending to other 
areas. Group 3 receives the same exercises along with electrotherapy consisting of 20 minutes 
of infrared therapy, continuous ultrasound at 2 W/cm² applied for 7 minutes on each side, and 
20 minutes of conventional TENS applied over the painful area. 
Each exercise session lasts 50 minutes, including 10 minutes of warm-up, 30 minutes of 
stabilization exercises, and 10 minutes of cool-down. Stabilization exercises are individually 
selected from an exercise pool and progress according to the participants’ needs. The exercises 
are delivered face-to-face twice a week for 8 weeks. Additionally, participants are provided with 
illustrated brochures and are instructed to perform the exercises at home for one hour every day. 
Outcome Measures 
After providing detailed information about the study and obtaining informed consent, the 
physical characteristics and demographic data of all participants are recorded. Neck pain is 
assessed using the Bournemouth Neck Questionnaire, while neck-related disability is evaluated 
with the Neck Disability Index. Endurance is measured using the Deep Cervical Flexor Test, 
and quality of life is assessed with the World Health Organization Quality of Life-BREF 
(WHOQOL-BREF). Cervical range of motion is measured using a universal goniometer. To 
evaluate scapular dyskinesis, the Lateral Scapular Slide Test (LSST) and the Scapular 
Dyskinesis Test (SDT) are performed. All participants complete the questionnaires at baseline 
and at the 8th week, and all measurements are conducted and recorded by physiotherapists. 

Statistical Analysis Plan 
Sample Size Calculation 
The number of participants to be included in the study was determined using the G*Power 3.1 
program, based on a similar reference study (Dusunceli, Y., Ozturk, C., Atamaz, F., Hepguler, 
S., & Durmaz, B. (2009). Efficacy of neck stabilization exercises for neck pain: a randomized 
controlled study. Journal of Rehabilitation Medicine, 41(8), 626–631). The sample size 
calculation was based on our primary outcome parameter, range of motion (ROM). Power 
analysis indicated that at least 24 participants would be required to achieve 95% power with a 
95% confidence interval. Considering a 10% drop-out rate, the final sample size was 
determined to be 27 participants. 
Statistical Analysis 
To compare baseline and post-treatment outcomes, ANOVA or Student’s t-test is used for 
parametric data, while the Kruskal–Wallis and Mann–Whitney U tests are applied for non-
parametric data. When significant differences among the three groups are detected, one-way 
analysis of variance (ANOVA) is conducted to determine the source of the difference. For 
pairwise comparisons, the Bonferroni post-hoc test is employed. A p-value of <0.05 is 
considered statistically significant.