Chronic Low-back Pain
Conditions
Brief summary
Connective tissue massage (CTM) is a manual therapy method that aims to modulate the autonomic response using special stroking techniques performed on connective tissue, and its analgesic effects are described in the literature. However, studies examining the effects of CTM on multidimensional parameters such as mobility, flexibility, endurance, balance, proprioception, emotional state, and quality of life, in addition to pain and disability in chronic low back pain, are limited. This study is designed as a randomized controlled trial to evaluate the multifaceted effects of KDM applied in addition to exercise and sham massage in individuals with chronic low back pain. The study will include a total of 40 participants aged 18-65 years who have experienced low back pain for at least six months. The eight-week interventions will be conducted twice weekly; all assessments will be performed before and after treatment. The study will assess pain (VAS), functional status (RMDQ), quality of life (NHP), fatigue (FSS), sleep quality (PUKİ), lumbar mobility, flexibility, balance, core endurance, and autonomic functions.
Interventions
Application of connective tissue massage in addition to exercise program
OTHERSham connective tissue massage
Application of sham connective tissue massage in addition to exercise program
Sponsors
Okan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants aged 18-65 who have had chronic low back pain in the past 6 months, have a VAS score above 3, do not have any disease that prevents them from working, and are volunteers will be included in the study.
Exclusion criteria
* pregnant women, * individuals with fibromyalgia and chronic fatigue syndrome, * individuals with uncontrolled hypertension, * cancer, and diabetes, * individuals with lumbar spine fractures and those who have undergone surgical interventions in the back region, * and individuals who are unwilling or uncooperative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability Level | From the enrollement to 8 weeks | Roland-Morris Disability Questionnaire: The Roland-Morris Disability Questionnaire (RMDQ) is one of the most widely used tools developed to assess the functional status of patients with low back pain. This questionnaire is a self-administered scale used to measure disability in individuals with low back pain, and it is based on selected statements from the Sickness Impact Profile. |
| Flexibility | From the enrollement to 8 weeks | Hamstring flexibility: The participant will be asked to raise one leg upwards without bending the knee while lying on their back. At the final point, the distance between the lateral malleolus and the bed will be measured. |
| Core Muscle Endurance | From the enrollement to 8 weeks | Core muscle static endurance will be assessed using the McGill Static Endurance Test Battery. This test will be evaluated using trunk flexion, extension, and right and left lateral bridge tests. A stopwatch will be used for measurements. Results will be recorded in seconds. The test ends when the position is compromised or the participant states they cannot continue. Trunk Flexion Test Trunk Extension Test Lateral Bridge Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance | From the enrollement to 8 weeks | Single-Leg Balance Test (Static Assessment): The participant is instructed to stand on one leg with their arms crossed over their chest, lifting one leg with the knee flexed at approximately a 45° angle, closing their eyes, and maintaining their balance in this position without opening their eyes. Once the correct position is achieved, a stopwatch is started, and the test is performed for a maximum of 30 seconds. If the participant uses their leg or arm for support, or opens their eyes, the stopwatch is stopped, and the time is recorded in seconds. |
| lumbar region mobility | From the enrollement to 8 weeks | The Modified Schober Test will be administered to assess participants' lumbar spine flexibility. The test is administered by standing the patient with their feet 30 centimeters apart. The midpoint of the posterior superior iliac spine, corresponding to the S2 vertebra, is located. Marks are made 10 centimeters upwards and 5 centimeters downwards from this point. The participant is asked to bend forward as far as possible, keeping their arms at their sides and their knees straight. After reaching the maximum bending position, the distances between the previously marked points are measured. The resulting value is then subtracted from the previous distance of 15 centimeters between the two marked points, and the resulting value is recorded. |
| Sleep Quality | From the enrollement to 8 weeks | Pittsburgh Sleep Quality Index: The PUKI (Personal Sleep Quality Assessment) is a 19-item self-report scale that assesses sleep disturbance and quality over the past month. It consists of 24 questions in total. 19 of these are self-report questions answered by the patient themselves. The remaining 5 questions are answered by the patient's spouse or roommate and are used for clinical information only; they are not included in the scoring. The self-report questions cover various factors related to sleep quality. The total score ranges from 0 to 21. A total score above 5 indicates that the individual is experiencing significant sleep disturbance or mild to moderate disturbance in multiple areas. |
| Fatigue Severity | From the enrollement to 8 weeks | Fatigue Severity Scale: The minimum score is 9 and the maximum is 63. A total score of 36 or higher indicates severe fatigue. |
| Quality of Life Level | From the enrollement to 8 weeks | Nottingham Health Profile: The NHP assesses perceived social, emotional, and physical health issues. It consists of six sections: physical activity (eight items), pain (eight items), energy level (three items), emotional reactions (nine items), sleep (five items), and social isolation (five items). The scale contains a total of 38 questions. Each question is answered with a yes or no response. Each section is scored from 0 to 100, with 0 representing the best health status and 100 representing the worst. |
| Pain Severity | From the enrollement to 8 weeks | Visual Analog Scale: A numerical pain scale will be used to assess pain during activity, rest, and night. This scale is an 11-point scale scored from 0 to 10: "0" = no pain, "10" = the most severe pain imaginable. Participants verbally choose the value that best reflects the severity of pain they experienced in the past 24 hours. |
Outcome results
None listed