Body Temperature Clinical Trial
Official title:
Comparison of the Effects of Connective Tissue Massage and Classical Massage Methods on Pain, Flexibility, Disability and Autonomic Responses in Chronic Mechanical Back Pain, Randomized Study
As a randomized study, this study aimed to investigate the effects of classical massage and connective tissue massage on pain, flexibility, disability, quality of life and autonomic responses in patients with chronic mechanical low back pain. The primary evaluation parameter of the study is autonomic function and the secondary evaluation parameter is pain. The participants will be treated accompanied with same physiotherapist along four weeks and five days in a week. A six-week follow-up will be performed to see how long the effect of the treatment continues.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | June 15, 2020 |
Est. primary completion date | December 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Being between 20-60 years of age - Low back pain for more than 12 weeks - Lack of neurological problems caused by lumbar region - Not to be included in physiotherapy and rehabilitation program in the last 6 months Exclusion Criteria: - Having ankylosing spondylitis - Pain and / or numbness in the hip and lower extremities - Previous trauma or surgery in lumbar region - Presence of congenital malalignment in the vertebral column - Malignancy - Lower limb inequality over one cm - Pregnancy - Blood pressure difference of more than 10 mmHg between two arms |
Country | Name | City | State |
---|---|---|---|
Turkey | Eastern Mediterranean University | Mersin | Famagusta |
Lead Sponsor | Collaborator |
---|---|
Eastern Mediterranean University |
Turkey,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in autonomic function (pulse) compared with baseline and last measurement | Pulse will be measured with pulse oximeter (pulse/min). | Measurements will be made at baseline and 4th week (last assessment). It takes about one minute. | |
Primary | Changes in autonomic function (blood pressure) compared with baseline and last measurement | Blood pressure will be measured with manual sphygmomanometer (mmHg). | Measurements will be made at baseline and 4th week (last assessment). It takes about two minutes | |
Primary | Changes in autonomic function (temperature) compared with baseline and last measurement | Local temperature and peripheral temperature measurements will be made with laser-marked heat meter (°C). | Measurements will be made at baseline and 4th week (last assessment). It takes about five minutes | |
Primary | Changes in low back pain compared with baseline and last measurement | Low back pain will be measured with using Visual Analog Scale (cm). | Measurements will be made at baseline and 4th week (last assessment). It takes about one minute. | |
Secondary | Changes in disability compared to baseline with baseline and last measurement | Disability will be measured with Oswestry Disability Index (0 - 100) | Measurements will be made at baseline and 4th week (last assessment). It takes about three minutes. | |
Secondary | Changes in quality of life compared to baseline with baseline and last measurement | Quality of life will be measured with Short Form 36 (0 - 100) | Measurements will be made at baseline and 4th week (last assessment). It takes about three minutes. | |
Secondary | Changes in flexibility (lumbar lateral flexion test) compared to baseline with baseline and last measurement | Lumbar lateral flexion test will be measured with tape measure (cm). | Measurements will be made at baseline and 4th week (last assessment). It takes about five minutes. | |
Secondary | Changes in flexibility (sit and reach) compared to baseline with baseline and last measurement | Sit and reach test will be measured with special table (cm). | Measurements will be made at baseline and 4th week (last assessment). It takes about two minutes. | |
Secondary | Changes in autonomic function (pulse) at six weeks after the end of the treatment | Pulse will be measured with pulse oximeter (pulse/min). | Measurements will be made at six weeks after the end of the treatment. It takes about one minute. | |
Secondary | Changes in autonomic function (blood pressure) at six weeks after the end of the treatment | Blood pressure will be measured with manual sphygmomanometer (mmHg). | Measurements will be made at six weeks after the end of the treatment. It takes about two minutes | |
Secondary | Changes in autonomic function (temperature) at six weeks after the end of the treatment | Local temperature and peripheral temperature measurements will be made with laser-marked heat meter (°C). | Measurements will be made at six weeks after the end of the treatment. It takes about five minutes | |
Secondary | Changes in low back pain at six weeks after the end of the treatment | Low back pain will be measured with using Visual Analog Scale (cm) | Measurements will be made at six weeks after the end of the treatment. It takes about one minute. | |
Secondary | Changes in disability at six weeks after the end of the treatment | Disability will be measured with Oswestry Disability Index (0 - 100) | Measurements will be made at six weeks after the end of the treatment. It takes about three minutes. | |
Secondary | Changes in quality of life at six weeks after the end of the treatment | Quality of life will be measured with Short Form 36 (0 - 100). | Measurements will be made at six weeks after the end of the treatment. It takes about three minutes. | |
Secondary | Changes in flexibility (lumbar lateral flexion) at six weeks after the end of the treatment | Lumbar lateral flexion test will be measured with tape measure (cm). | Measurements will be made at six weeks after the end of the treatment. It takes about two minutes. | |
Secondary | Changes in flexibility (sit and reach) at six weeks after the end of the treatment | Sit and reach test will be measured with special table (cm). | Measurements will be made at six weeks after the end of the treatment. It takes about two minutes. |
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