Low Back PainNCT05769192
Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain
A study testing Classical physiotherapy and classical massage in people with Low Back Pain, run by Ankara Yildirim Beyazıt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Classical physiotherapy and classical massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65,
- Having non-specific low back pain lasting at least 3 months,
- Individuals willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Classical physiotherapy and classical massage, Classical physiotherapy and placebo massage
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical physiotherapy and classical massageOther
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.
Classical physiotherapy and placebo massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will be applied classical physiotherapy and classical massage Receives: Other: Classical physiotherapy and classical massage |
| Group 2 | Placebo comparator | Group 2 will be applied classical physiotherapy and placebo massage Receives: Other: Classical physiotherapy and placebo massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 3 weeks
Secondary outcomes (4)
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.
Measured: change from baseline at 3 weeks
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.
Measured: change from baseline at 3 weeks
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.
Measured: change from baseline at 3 weeks
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.
Measured: change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start30 Mar 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769192
- Sponsor's protocol ID
- 2023/03/04
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ucurum SG, Celenay ST, Keskin M, Kaya DO. Short-term effects of classical massage added to a conventional physiotherapy on non-specific chronic low back Pain: A randomized, placebo-controlled study. J Bodyw Mov Ther. 2025 Oct;44:73-79. doi: 10.1016/j.jbmt.2025.05.036. Epub 2025 May 21.
PubMed 40954653
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Classical Massage Application on Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05769192
- Acronym / sponsor ID
- 2023/03/04
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Classical physiotherapy and classical massageGroup 1 will be applied classical physiotherapy and classical massage |
| Group 2 | Placebo comparator | Other: Classical physiotherapy and placebo massageGroup 2 will be applied classical physiotherapy and placebo massage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-65,
- Having non-specific low back pain lasting at least 3 months,
- Individuals willing to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classical physiotherapy and classical massageWithin 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. | Other | Group 1 |
| Classical physiotherapy and placebo massageWithin 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. | Other | Group 2 |
Primary outcome
Pain intensity
Time frame: change from baseline at 3 weeks
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.
4 secondary outcomes
Spinal mobility
Time frame: change from baseline at 3 weeks
Functional status
Time frame: change from baseline at 3 weeks
Psychological state
Time frame: change from baseline at 3 weeks
Life quality
Time frame: change from baseline at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 40954653Ucurum SG, Celenay ST, Keskin M, Kaya DO. Short-term effects of classical massage added to a conventional physiotherapy on non-specific chronic low back Pain: A randomized, placebo-controlled study. J Bodyw Mov Ther. 2025 Oct;44:73-79. doi: 10.1016/j.jbmt.2025.05.036. Epub 2025 May 21.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Classical physiotherapy and classical massage in people with Low Back Pain, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: change from baseline at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.