Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality
Phase: NA
Conditions: MECHANICAL BACK PAIN, Sleep Quality
Sponsor: Ayşe BAŞAYAN

Cover Page 
Official Title: 
Comparison of the Effects of Thoracic Manipulation and Classical Massage on Pain, Flexibility, and 
Sleep in Patients with Mechanical Back Pain 
NCT Number: 
NCTXXXXXXXX 
Document Date: 
April 2026 
STUDY PROTOCOL 
1. Background and Objective 
Mechanical back pain is a common musculoskeletal condition affecting quality of life, physical 
function, and sleep. Manual therapy techniques such as thoracic manipulation and classical massage 
are widely used in physiotherapy practice; however, their comparative effectiveness remains unclear. 
Objective: 
To compare the effects of thoracic manipulation and classical massage on pain, flexibility, and sleep 
quality in patients with mechanical back pain. 
2. Study Design 
• 
Study Type: Interventional  
• 
Allocation: Randomized  
• 
Model: Parallel Assignment  
• 
Number of Arms: 2  
• 
Primary Purpose: Treatment  
3. Participants 
Inclusion Criteria 
• 
Aged between 18–65 years  
• 
Mechanical back pain for at least 3 months  
• 
Voluntary participation  
Exclusion Criteria 
• 
History of spinal surgery  
• 
Neurological or systemic diseases  
• 
Acute trauma  
• 
Pregnancy  
4. Sample Size 
• 
Total: 60 participants  
• 
Classical Massage Group: 30  
• 
Thoracic Manipulation Group: 30  

5. Interventions 
Common Treatment (Both Groups) 
• 
Hot pack: 20 minutes 
• 
TENS: 20 minutes  
Group 1: Classical Massage 
• 
Frequency: 2 times/week for 4 weeks  
• 
Region: Upper back  
• 
Techniques:  
o 
General stroking (3 repetitions)  
o 
Stroking and kneading applied to erector spinae and trapezius muscles (3 repetitions 
each)  
o 
Final general stroking 
Group 2: Thoracic Manipulation 
• 
Frequency: 1 time/week for 4 weeks  
• 
Region: T1–T12 vertebrae  
• 
Techniques:  
o 
Bilateral hypothenar manipulation (prone)  
o 
Butterfly technique  
o 
Unilateral prone manipulation  
o 
Dog technique  
o 
Costotransverse manipulation  
o 
Upper and mid-thoracic manipulation techniques  
6. Outcome Measures 
Primary Outcome 
• 
Pain intensity (Visual Analog Scale – VAS)  
Secondary Outcomes 
• 
Quality of life (SF-36)  
• 
Sleep quality (Pittsburgh Sleep Quality Index – PSQI)  
• 
Postural assessment (New York Posture Analysis)  
• 
Flexibility tests:  
o 
Sit-and-reach  
o 
Trunk extension  
o 
Right and left lateral flexion  
• 
Muscle strength and endurance tests  
7. Assessment Timeline 
• 
Baseline (Pre-treatment)  
• 
Post-treatment (4 weeks)  
8. Ethical Considerations 

• 
Informed consent obtained from all participants  
• 
Study conducted in accordance with the Declaration of Helsinki  
• 
Approved by the relevant Ethics Committee  
 STATISTICAL ANALYSIS PLAN (SAP) 
1. Software: Statistical analyses performed using SPSS  
2. Data Analysis: Normality assessed using Shapiro-Wilk test  
Within-group comparisons: Paired t-test (parametric data), Wilcoxon test (non-parametric data)  
Between-group comparisons: Independent t-test (parametric data); Mann–Whitney U test (non-
parametric data)  
3. Significance Level: p < 0.05 considered statistically significant  
4. Missing Data Handling: Analysis performed using available data; Missing data not imputed  
5. Outcome Evaluation: Changes from baseline to post-treatment analyzed; Group differences 
evaluated based on change scores