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| ID | Type | Description | Link |
|---|---|---|---|
| Istanbul Rumeli University | Other Identifier | Istanbul Rumeli University |
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Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain
Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| classical Massage | Experimental | Classical Massage Group |
|
| Manuel Therapy | Active Comparator | Manuel Therapy Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classical Massage | Other | Classical Massage |
| |
| Manual therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment | VAS will be used to measure pain intensity. A 10 cm long line is used, where 0 represented no pain and 10 represented very severe pain. The distance from the marked point to 0 is recorded as a VAS score. | From enrollment and after 4 weeks |
| Sit and Reach test | The participant is asked to sit with their feet extended under the test bench. Without bending their knees, they are asked to lean their body forward and reach as far as possible on their fingertips, holding at that point for 2 seconds. | From enrollment and after 4 weeks |
| Trunk extension | Trunk extension: In the trunk extension flexibility test, the participant stands facing the wall, with their hips and torso in contact with the wall. The distance between the sternal notch and the wall is measured using a tape measure. | From enrollment and after 4 weeks |
| Lateral flexion | Right and left trunk lateral flexion flexibility test: The participant is positioned standing; feet shoulder-width apart, knees straight, torso upright, hips and shoulders in a neutral position. The participant's middle finger is used as the measurement point. During the measurement, the zero point of the measuring tape is placed in line with the middle finger. | from enrollment and after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| endurance test | The dynamic sit-up test is used to assess the endurance of the trunk flexor muscles of the participants, and the trunk extensor muscle endurance test is used to assess trunk extensor muscle endurance. In these measurements, the number of repetitions completed by the participants in 60 seconds is noted. | from enrollment and after 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bigadic Saglikli Yasam Merkezi | Istanbul | 10000 | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2026 | Apr 2, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Other |
Manual therapy |
|
| Quality of life assessment | The Short Form-36 will assess mental and physical health. This form will examine participants' physical and mental health status across eight sub-dimensions. Quality of life will be assessed through eight sub-dimensions: physical function, social function, physical role difficulty, emotional role difficulty, mental health, vitality, body pain, and general health. | From enrollment and after 4 weeks |
| Sleep quality | The Pittsburgh Sleep Quality Index (PSQI) will be used as a valid and reliable assessment tool to provide information about participants' sleep quality, as well as the type and severity of sleep disturbances over the past month. The scale will consist of 19 self-reported items and 7 sub-dimensions. In this measure, the following parameters will be evaluated: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item on the scale will be scored between 0 and 3. | from enrollment and after 4 weeks |
| D001523 |
| Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |