MECHANICAL BACK PAINNCT07518732
Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality
A study testing Classical Massage and Manual therapy in people with MECHANICAL BACK PAIN and Sleep Quality, run by Ayşe BAŞAYAN at 1 site in Turkey (Türkiye).
Trial summary
Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MECHANICAL BACK PAIN, Sleep Quality
- What is being tested?
- Classical Massage and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 and being 65 years old
- Those who have experienced thoracic back problems for at least 3 years
- Being able to communicate in Turkish
- Having reading and writing proficiency
- To ensure voluntary interest in work
- Being symptomatic and healthy
- Those with functional scoliosis
Who cannot join
- Being under 18 or 65 years old
- Those with congenital and idiopathic scoliosis
- Cases using cortisone in the last 6 weeks
- Those who do not lie face down
- History of traumatic injury to the Thoracic Spine
- Those who have had spinal surgery
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- Those diagnosed with osteoporosis, bone tumor and rheumatoid
- Pregnancy
- Individuals with a history of neurological diseases (stroke, multiple sclerosis, Parkinson's)
- History of cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bigadic Saglikli Yasam Merkezi
Istanbul, 10000
About this study
Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain
Read the detailed description
Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality
- Conditions
- MECHANICAL BACK PAIN, Sleep Quality
- Being tested
- Classical Massage, Manual therapy
- Keywords
- Mechanical Back Pain, Massage, Manipulation, Flexibility, Sleep Quality, Pain
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical MassageOther
Classical Massage
Manual therapyOther
Manual therapy
| Study group | Role | What they receive |
|---|---|---|
| classical Massage | Experimental | Classical Massage Group Receives: Other: Classical Massage |
| Manuel Therapy | Active comparator | Manuel Therapy Group Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from enrollment and after 4 weeks
Secondary outcomes (3)
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.
Measured: from enrollment and after 4 weeks
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.
Measured: 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.
Measured: from enrollment and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MECHANICAL BACK PAINStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayşe BAŞAYAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe BAŞAYAN, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518732
- Sponsor's protocol ID
- İRU-FTR-AB-01
- Other IDs
- Istanbul Rumeli University
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality
- ClinicalTrials.gov ID
- NCT07518732
- Acronym / sponsor ID
- İRU-FTR-AB-01
- Conditions
- MECHANICAL BACK PAIN, Sleep Quality
- Keywords
- Mechanical Back Pain, Massage, Manipulation, Flexibility, Sleep Quality, Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ayşe BAŞAYANUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 9 Apr 2026 (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.
Investigation Of The Effects Of Thoracic Manipulation And Classical Massage On Pain Flexibility And Sleep Quality In Patients With Mechanical Back Pain
Detailed description
Investigation of the Effect of Thoracic Manipulation and Classical Massage on Pain, Flexibility and Sleep Quality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical Massage | Experimental | Other: Classical MassageClassical Massage Group |
| Manuel Therapy | Active comparator | Other: Manual therapyManuel Therapy Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being over 18 and being 65 years old
- Those who have experienced thoracic back problems for at least 3 years
- Being able to communicate in Turkish
- Having reading and writing proficiency
- To ensure voluntary interest in work
Key exclusion criteria (10 listed)
- Being under 18 or 65 years old
- Those with congenital and idiopathic scoliosis
- Cases using cortisone in the last 6 weeks
- Those who do not lie face down
- History of traumatic injury to the Thoracic Spine
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 MassageClassical Massage | Other | classical Massage |
| Manual therapyManual therapy | Other | Manuel Therapy |
Primary outcome
Pain Assessment
Time frame: From enrollment and after 4 weeks
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.
Sit and Reach test
Time frame: From enrollment and after 4 weeks
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.
Trunk extension
Time frame: From enrollment and after 4 weeks
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.
Lateral flexion
Time frame: from enrollment and after 4 weeks
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.
3 secondary outcomes
endurance test
Time frame: from enrollment and after 4 weeks
Quality of life assessment
Time frame: From enrollment and after 4 weeks
Sleep quality
Time frame: from enrollment and after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Massage and Manual therapy in people with MECHANICAL BACK PAIN and Sleep Quality, run by Ayşe BAŞAYAN at 1 site in Turkey (Türkiye).
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 7 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: From enrollment and after 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.