Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Classical physiotherapy and classical massage
Classical physiotherapy and placebo massage
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria: Between the ages of 18-65, Having non-specific low back pain lasting at least 3 months, Individuals willing to participate in the study Exclusion Criteria: Having different pain syndromes (eg fibromyalgia) Having a history of spinal surgery or invasive examination in the last 6 months, Having a neurological or psychiatric disease Any ongoing related pathology (eg spondylolisthesis, fractures, tumor, osteoporosis or infection), Those with pregnancy status
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
Group 1 will be applied classical physiotherapy and classical massage
Group 2 will be applied classical physiotherapy and placebo massage
Outcomes
Primary Outcome Measures
Pain intensity
Pain intensity will be evaluated with a 10 cm Visual Analog Scale (VAS). The VAS is scored on a 10 cm horizontal line, with 0 meaning "no pain" and 10 "worst pain imaginable". Patients will be asked to mark their lower back pain on the horizontal line.
Secondary Outcome Measures
Spinal mobility
Spinal mobility will be assessed with the Modified Shober test. With the patient in an upright position, a mark will be made at the midpoint of the imaginary line joining the posterior superior iliac spine on the back. Another mark will be made 10 cm above and 5 cm below this mark. The patient will be asked to lean forward maximally, keeping the knees fully extended. The distance between these marks will be measured. Mobility will be recorded by calculating the difference between the upright and maximum flexion end positions. It is stated that the greater the difference, the greater the mobility.
Functional status
Functional status will be assessed with the Oswestry Disability Index (ODI) . The index consists of 10 items (pain severity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, travel) and is scored on a 0-5-point scale based on functional performance. Higher scores indicate more severe disability.
Psychological state
Psychological state will be evaluated using the Hospital Anxiety Depression Scale. The scale has 14 items, 7 of which with odd numbers represent anxiety while the other 7 with even numbers represent depression.
Higher scores indicate more severe anxiety or depression.
Life quality
Life quality will be evaluated with the Short Form (SF-36) consisting of 36 items. It includes eight different fields: general health, bodily pain, physical function, physical and mental role limitations, mental health, vitality, and social function. The eight fields can be join mainly the physical component summary and the mental component summary that reflects physical and mental health. While '100' is the best score the '0' is the worst and higher scores indicate better life quality.
Full Information
NCT ID
NCT05769192
First Posted
March 3, 2023
Last Updated
March 3, 2023
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05769192
Brief Title
Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain
Official Title
Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 30, 2023 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to examine the effects of classical massage on pain, spinal mobility, functional and psychological state, and life quality in individuals with chronic low back pain.
Detailed Description
Low back pain is one of the most common problems in society, experienced by 70-80% of individuals at least once in their lifetime. Physical pain can cause serious functional losses that affect independence in daily life. In patients with low back pain, physical endurance decreases because of pain, spasm, decrease in muscle strength and deteriorated posture, and the functional capacity and quality of life of the patient are negatively affected. While most individuals recover spontaneously, 2-8% of them require medical treatment, and the response to conservative treatment is generally good. Along with medical treatment, different physiotherapy methods (electro-physical agents, massage, traction, exercises, etc.), which are conservative treatment methods, are also frequently used. It is known that classical physiotherapy modalities (heating agents and exercise approaches) have an important place in the treatment of these patients due to their positive effects on pain, strength, flexibility and functionality. Massage is used to systematically manipulate the soft tissues of the body with rhythmic pressure and to provide or maintain health. Basically, massage is a simple way to provide pain relief through physical and mental relaxation. It is thought to relieve pain in various ways, including increasing the pain threshold by secreting endorphins and closing the pain gate at the spinal cord level. Classical massage is considered rehabilitative and is also used to reduce symptoms associated with medical conditions. It has been reported that classical massage reduces many physical and psychological symptoms in different musculoskeletal problems (neck pain, fibromyalgia, etc.). However, there is a need for placebo-controlled studies in the literature examining the effects of classical massage in individuals with chronic low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 will be applied classical physiotherapy and classical massage
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Group 2 will be applied classical physiotherapy and placebo massage
Intervention Type
Other
Intervention Name(s)
Classical physiotherapy and classical massage
Intervention Description
Within the scope of classical physiotherapy, hot pack will be applied for 20 minutes to the muscles in the lumbar region in the prone position. Stretching and strengthening exercises for the abdominal, lumbar and hip muscles will be given. Classical massage, known as Swedish massage, will be applied on the lumbar region in prone position. All applications will be done 5 days a week for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Classical physiotherapy and placebo massage
Intervention Description
Within the scope of classical physiotherapy, hot pack will be applied for 20 minutes to the muscles in the lumbar region in the prone position. Stretching and strengthening exercises for the abdominal, lumbar and hip muscles will be given. In addition, placebo massage, applied without using any technique, will be applied to the lumbar region in the prone position. All applications will be done 5 days a week for 3 weeks.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be evaluated with a 10 cm Visual Analog Scale (VAS). The VAS is scored on a 10 cm horizontal line, with 0 meaning "no pain" and 10 "worst pain imaginable". Patients will be asked to mark their lower back pain on the horizontal line.
Time Frame
change from baseline at 3 weeks
Secondary Outcome Measure Information:
Title
Spinal mobility
Description
Spinal mobility will be assessed with the Modified Shober test. With the patient in an upright position, a mark will be made at the midpoint of the imaginary line joining the posterior superior iliac spine on the back. Another mark will be made 10 cm above and 5 cm below this mark. The patient will be asked to lean forward maximally, keeping the knees fully extended. The distance between these marks will be measured. Mobility will be recorded by calculating the difference between the upright and maximum flexion end positions. It is stated that the greater the difference, the greater the mobility.
Time Frame
change from baseline at 3 weeks
Title
Functional status
Description
Functional status will be assessed with the Oswestry Disability Index (ODI) . The index consists of 10 items (pain severity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, travel) and is scored on a 0-5-point scale based on functional performance. Higher scores indicate more severe disability.
Time Frame
change from baseline at 3 weeks
Title
Psychological state
Description
Psychological state will be evaluated using the Hospital Anxiety Depression Scale. The scale has 14 items, 7 of which with odd numbers represent anxiety while the other 7 with even numbers represent depression.
Higher scores indicate more severe anxiety or depression.
Time Frame
change from baseline at 3 weeks
Title
Life quality
Description
Life quality will be evaluated with the Short Form (SF-36) consisting of 36 items. It includes eight different fields: general health, bodily pain, physical function, physical and mental role limitations, mental health, vitality, and social function. The eight fields can be join mainly the physical component summary and the mental component summary that reflects physical and mental health. While '100' is the best score the '0' is the worst and higher scores indicate better life quality.
Time Frame
change from baseline at 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18-65,
Having non-specific low back pain lasting at least 3 months,
Individuals willing to participate in the study
Exclusion Criteria:
Having different pain syndromes (eg fibromyalgia)
Having a history of spinal surgery or invasive examination in the last 6 months,
Having a neurological or psychiatric disease
Any ongoing related pathology (eg spondylolisthesis, fractures, tumor, osteoporosis or infection),
Those with pregnancy status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda Toprak Celenay
Phone
+90312 906 1000
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain
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