Back PainNCT06704373
The Effects of Thoracic Manipulation on Peripheral Muscle Oxygenation
A study testing thoracal manipulation and Exercise in people with Back Pain and Spine Stiffness, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Office workers spend 70-85% of their time sitting, which leads to postural disorders and musculoskeletal system diseases. Back pain is the most common health problem among office workers who need to sit. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Back Pain, Spine Stiffness, Sedentary Behavior
- What is being tested?
- thoracal manipulation and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 30 May 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active desk-based office worker for the past 3 months
- Age between 20 and 50 years
- Back pain experience in the last 3 months
- Willing to participate in the study
Who cannot join
- Diagnosis of osteoporosis
- Presence of a newly formed fracture
- Recent trauma
- Cancer
- Osteomyelitis
- Hypermobility
Show all 10Show fewer
- Ankylosing spondylitis
- Presence of an aneurysm
- Presence of vascular occlusion
- Malignancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir University
Beşiktaş, Istanbul, 34353
About this study
Official title: Effect of Thoracic Manipulation on Peripheral Muscle Oxygenation, Pain, and Disability in Office Workers With Back Pain
Office workers spend 70-85% of their time sitting, which leads to postural disorders and musculoskeletal system diseases. Back pain is the most common health problem among office workers who need to sit. Studies have shown that spinal manipulation can help reduce back pain by decreasing the stiffness of spine segments associated with joint dysfunction. The primary aim of this study is to investigate the effects of thoracic spinal manipulation on peripheral oxygenation, pain, and disability of the back muscles in office workers with back pain, at acute, 10-day, and 4-week follow-up periods. The secondary aim is to evaluate whether the parameters have a significant relationship.
The study will include volunteers aged 20-50 who are active office workers with no orthopedic, neurological, or psychological disorders, who have experienced back pain in the last 3 months, and who have a numerical pain scale score of at least 30 mm out of 100 mm. Participants will be randomized into the thoracic spinal manipulation and the control groups. Both groups will receive postural exercises. The thoracic spinal manipulation group will receive a single session of spinal manipulation, while the control group will only receive postural exercises. The study is expected to find significant improvement in peripheral muscle oxygenation, back pain, and disability scores following thoracic spinal manipulation. This study aims to contribute to the literature by focusing on how peripheral muscle oxygenation is affected by thoracic spinal manipulation.
Read the detailed description
Office workers spend 70-85% of their time sitting at their workplaces, with an average working time of 8 hours. This prolonged inactivity can lead to serious health issues such as musculoskeletal disorders, repetitive movements, static postures, and improper body positions. Due to their limited mobility, office workers are at risk of experiencing problems with their body postures. Studies have shown that back pain is a common issue among office workers. However, thoracic spine pain between the T1-T12 vertebrae is less studied and less debilitating than cervical and lumbar pain. The most common causes of back pain are muscle tension, trauma, acute injury, strain, or poor posture. The posture, mobility, and stability of the thoracic spine are important factors in pain syndromes and degenerative changes. The success of treatment relies on understanding the anatomy and biomechanics of the spine. Research on mechanoreceptor effects is significant for manual therapy, including spinal manipulation and mobilization techniques. These therapies target intervertebral joints and affect adjacent joints and surrounding soft tissues. Chiropractic spinal manipulation, performed by professionals at the intersection of traditional and alternative medicine, has been found effective in treating back pain and reducing pain. Thoracic spinal manipulation may help relax spinal segments associated with secondary muscle spasms due to joint dysfunction. Studies have shown significant improvements in range of motion and pain in the acute period following thoracic manipulation. Spinal manipulation combined with exercise can enhance an individual's quality of life and improve pain conditions.
NIRS (near-infrared spectroscopy) has been used to measure the oxygen status of muscle tissue, demonstrating the balance between muscle oxygen delivery and tissue V̇O2. The fascial system encompassing the large muscle groups in the back can lead to muscle overload, reducing blood flow and creating myofascial adhesions. A recent study presented initial evidence that myofascial reorganization techniques could improve trapezius muscle tissue oxygenation and peripheral blood flow in patients with neck pain.
To our knowledge, there are no studies evaluating the effect of spinal manipulation on muscle oxygenation in individuals with back pain. Our research aims to contribute to the literature by examining the changes in oxygenation, pain, and disability in the upper trapezius and interscapular region and lumbar spine muscles following a single session of thoracic spinal manipulation.
- Conditions
- Back Pain, Spine Stiffness, Sedentary Behavior, Disability Physical
- Being tested
- thoracal manipulation, Exercise
- Keywords
- moxy, spinal pain, sedantary, chiropractic
- Medical subject headings
- Back Pain, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracal manipulationOther
Thoracal manipulation will be applied only one session.
ExerciseOther
Also called Postural Exercise
Both groups will perform the same postural exercises, which will be applied twice a week for 4 weeks. The intervention group will receive thoracic manipulation for one session.
| Study group | Role | What they receive |
|---|---|---|
| Manipulation group | Experimental | Thoracic spinal manipulation will be performed between the T1-T12 vertebral levels, based on the segment with movement limitations. The manipulation will be applied to the area of back pain using a high-velocity, low-amplitude thrust with a short-lever technique.
Also, the same postural exercises that were given to the control group will be given. Receives: Other: thoracal manipulation; Other: Exercise |
| Control Group | Active comparator | The postural exercises program will be given. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periferal muscle oxygen measurement
Muscle oxygen levels will be measured using the Moxy Monitor. The Moxy Monitor is a mobile, non-invasive method for measuring SmO2. The device uses near-infrared spectroscopy (NIRS) technology and features a patented algorithm that measures hemoglobin and myoglobin in capillaries and muscle tissues with a wearable monitor. Moxy device measures real-time muscle oxygenation (SmO2) and total hemoglobin (tHb) levels by using near-infrared spectroscopy.
Measured: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Secondary outcomes (3)
Oswestry Disability Index
The survey consists of ten items related to pain severity, sitting, standing, and social life, with each item rated by participants on a scale from 0 to 5. The total score is calculated by dividing the patient's score by the possible maximum score and then multiplying by 100. Therefore, the score of the Oswestry Disability Questionnaire ranges from 0 to 100, with a higher score indicating greater disability.
Measured: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Neck Disability Index
The Neck Disability Index (NDI) comprises ten items that assess the impact of neck pain on daily activities, including personal care, lifting, reading, and social life. Each item is rated by participants on a scale from 0 to 5, with higher scores indicating greater disability. The total score is calculated by dividing the participant's score by the maximum possible score and then multiplying by 100. Consequently, the NDI score ranges from 0 to 100, where a higher score reflects a higher level of disability associated with neck pain.
Measured: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Numeric Pain Scale
The Numeric Pain Scale (NPS) is a subjective measure used to assess pain intensity, where participants rate their pain on a scale from 0 to 100 mm. A score of 0 indicates no pain, while a score of 100 represents the worst imaginable pain. Participants mark their pain level on a line, and the distance from the zero point is measured to obtain the score.
Measured: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start10 Mar 2025
- Primary completion15 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Participants will be randomized into intervention (manipulation group) and control group.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Pişirici, Bahçeşehir University
- Investigators
- Alev Atasever, PT, Principal investigator, Bahcesehir University, Graduate Education Institute,Chiropractic Master of Science ProgramPelin Pişirici, PT, PhD, Study director, Bahcesehir University, Faculty of Health SciencesBerkay Eren Pejlivanoğlu, PT, PhD, Study chair, Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704373
- Sponsor's protocol ID
- Alev-Man24
- Status last verified
- Jul 2025
- First submitted
- 2 Oct 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Manipulation on Peripheral Muscle Oxygenation, Pain, and Disability in Office Workers With Back Pain
- ClinicalTrials.gov ID
- NCT06704373
- Acronym / sponsor ID
- Alev-Man24
- Conditions
- Back Pain, Spine Stiffness, Sedentary Behavior, Disability Physical
- Keywords
- moxy, spinal pain, sedantary, chiropractic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 Nov 2024 (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.
Office workers spend 70-85% of their time sitting, which leads to postural disorders and musculoskeletal system diseases. Back pain is the most common health problem among office workers who need to sit. Studies have shown that spinal manipulation can help reduce back pain by decreasing the stiffness of spine segments associated with joint dysfunction. The primary aim of this study is to investigate the effects of thoracic spinal manipulation on peripheral oxygenation, pain, and disability of the back muscles in office workers with back pain, at acute, 10-day, and 4-week follow-up periods. The secondary aim is to evaluate whether the parameters have a significant relationship.
The study will include volunteers aged 20-50 who are active office workers with no orthopedic, neurological, or psychological disorders, who have experienced back pain in the last 3 months, and who have a numerical pain scale score of at least 30 mm out of 100 mm. Participants will be randomized into the thoracic spinal manipulation and the control groups. Both groups will receive postural exercises. The thoracic spinal manipulation group will receive a single session of spinal manipulation, while the control group will only receive postural exercises. The study is expected to find significant improvement in peripheral muscle oxygenation, back pain, and disability scores following thoracic spinal manipulation. This study aims to contribute to the literature by focusing on how peripheral muscle oxygenation is affected by thoracic spinal manipulation.
Detailed description
Office workers spend 70-85% of their time sitting at their workplaces, with an average working time of 8 hours. This prolonged inactivity can lead to serious health issues such as musculoskeletal disorders, repetitive movements, static postures, and improper body positions. Due to their limited mobility, office workers are at risk of experiencing problems with their body postures. Studies have shown that back pain is a common issue among office workers. However, thoracic spine pain between the T1-T12 vertebrae is less studied and less debilitating than cervical and lumbar pain. The most common causes of back pain are muscle tension, trauma, acute injury, strain, or poor posture. The posture, mobility, and stability of the thoracic spine are important factors in pain syndromes and degenerative changes. The success of treatment relies on understanding the anatomy and biomechanics of the spine. Research on mechanoreceptor effects is significant for manual therapy, including spinal manipulation and mobilization techniques. These therapies target intervertebral joints and affect adjacent joints and surrounding soft tissues. Chiropractic spinal manipulation, performed by professionals at the intersection of traditional and alternative medicine, has been found effective in treating back pain and reducing pain. Thoracic spinal manipulation may help relax spinal segments associated with secondary muscle spasms due to joint dysfunction. Studies have shown significant improvements in range of motion and pain in the acute period following thoracic manipulation. Spinal manipulation combined with exercise can enhance an individual's quality of life and improve pain conditions.
NIRS (near-infrared spectroscopy) has been used to measure the oxygen status of muscle tissue, demonstrating the balance between muscle oxygen delivery and tissue V̇O2. The fascial system encompassing the large muscle groups in the back can lead to muscle overload, reducing blood flow and creating myofascial adhesions. A recent study presented initial evidence that myofascial reorganization techniques could improve trapezius muscle tissue oxygenation and peripheral blood flow in patients with neck pain.
To our knowledge, there are no studies evaluating the effect of spinal manipulation on muscle oxygenation in individuals with back pain. Our research aims to contribute to the literature by examining the changes in oxygenation, pain, and disability in the upper trapezius and interscapular region and lumbar spine muscles following a single session of thoracic spinal manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into intervention (manipulation group) and control group.
| Arm | Type | Receives |
|---|---|---|
| Manipulation group | Experimental | Other: thoracal manipulation, Other: ExerciseThoracic spinal manipulation will be performed between the T1-T12 vertebral levels, based on the segment with movement limitations. The manipulation will be applied to the area of back pain using a high-velocity, low-amplitude thrust with a short-lever technique. Also, the same postural exercises that were given to the control group will be given. |
| Control Group | Active comparator | Other: ExerciseThe postural exercises program will be given. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Active desk-based office worker for the past 3 months
- Age between 20 and 50 years
- Back pain experience in the last 3 months
- Willing to participate in the study
Key exclusion criteria (10 listed)
- Diagnosis of osteoporosis
- Presence of a newly formed fracture
- Recent trauma
- Cancer
- Osteomyelitis
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 |
|---|---|---|
| thoracal manipulationThoracal manipulation will be applied only one session. | Other | Manipulation group |
| ExerciseAlso: Postural ExerciseBoth groups will perform the same postural exercises, which will be applied twice a week for 4 weeks. The intervention group will receive thoracic manipulation for one session. | Other | Control Group, Manipulation group |
Primary outcome
Periferal muscle oxygen measurement
Time frame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Muscle oxygen levels will be measured using the Moxy Monitor. The Moxy Monitor is a mobile, non-invasive method for measuring SmO2. The device uses near-infrared spectroscopy (NIRS) technology and features a patented algorithm that measures hemoglobin and myoglobin in capillaries and muscle tissues with a wearable monitor. Moxy device measures real-time muscle oxygenation (SmO2) and total hemoglobin (tHb) levels by using near-infrared spectroscopy.
3 secondary outcomes
Oswestry Disability Index
Time frame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Neck Disability Index
Time frame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Numeric Pain Scale
Time frame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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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. This study is not recruiting at the moment.
Alev Atasever, PT principal investigator
Bahcesehir University, Graduate Education Institute,Chiropractic Master of Science Program
Pelin Pişirici, PT, PhD study director
Bahcesehir University, Faculty of Health Sciences
Berkay Eren Pejlivanoğlu, PT, PhD study chair
Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracal manipulation and Exercise in people with Back Pain and Spine Stiffness, run by Bahçeşehir University 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 4 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Periferal muscle oxygen measurement (time frame: Baseline, right after intervention, ten days after post intervention, four weeks after post intervention). 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 8 Jul 2025.