Manipulation, OsteopathicNCT07466368
The Effects of Manipulation on Pain, Quality of Life, and Functional Activity in People Who Practice Pilates.
A study testing manuel therapy and pilates in people with Manipulation, Osteopathic and Pilates Exercise, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial summary
Participants were randomly divided into two groups: a Pilates group (n=20) and a Pilates and spine-total body manipulation group (n=20). Both groups received a total of 8 sessions, 2 days a week, for 50 minutes each; one group received only Pilates, while the other group received Pilates combined with spine-total body… Read more about this study
- Who is it for?
- Ages 18 to 70 weeksHealthy volunteers can take part
- Conditions the study is for
- Manipulation, Osteopathic, Pilates Exercise, Non-specific Spinal Problems
- What is being tested?
- manuel therapy and pilates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 3 Jul 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 18 to 70 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ability to communicate in Turkish
- Willingness to participate in the study
- Non-specific mechanical lower back pain
- Non-specific mechanical neck pain
- Non-specific spinal problems
- Pain in the neck and shoulder girdle area
- Myofascial pain syndrome -having been doing Pilates for at least 4 weeks
Who cannot join
- Pregnancy
- Acute lower back pain
- Acute neck pain
- Recent surgery
- Idiopathic scoliosis
- Positive vertebral artery test
Show all 10Show fewer
- Vertigo
- Bone disease
- Cortisone use
- Having done Pilates for more than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REFORMER YAPAN NON-SPESİFİK OMURGA PROBLEMLİ OLGULARDA MANİPÜLASYONUN ETKİSİNİN DEĞERLENDİRİLMESİ
Participants were randomly divided into two groups: a Pilates group (n=20) and a Pilates and spine-total body manipulation group (n=20). Both groups received a total of 8 sessions, 2 days a week, for 50 minutes each; one group received only Pilates, while the other group received Pilates combined with spine-total body manipulation.
Read the detailed description
A study is planned at the LoveYour Body Healthy Living Center in Gaziantep, involving 20 clients with spinal problems who will receive 8 sessions of reformer pilates alone (2 days a week, 50 minutes each) and another 20 clients who will receive 8 sessions of reformer pilates and spinal-total body manipulation (2 days a week, 50 minutes each). The sample size was determined through a power analysis using a 5% significance level (α = 0.05), a moderate effect size (effect size = 0.5), and 80% test power (power = 0.80). The analysis, conducted using the G*Power program, calculated that a minimum of 35 participants is required. Participation in the study was voluntary, and initial assessments were conducted on the same day. Participants were defined as being over 18 years of age, volunteering to participate, and experiencing at least one of the following symptoms for at least 4 weeks: non-specific mechanical lower back pain, non-specific mechanical neck pain, non-specific spinal problems, or pain in the neck and shoulder girdle region, or diagnosed with myofascial pain syndrome. Exclusion included pregnant women, those with acute lower back and neck pain, those who had recently undergone surgery, those with idiopathic scoliosis, vertigo, or bone disease, those with a positive vertebral artery test, those using cortisone, and those who had been practicing Pilates for more than 3 months. Assessments were conducted on the day participants began and the day the program ended.
- Being tested
- manuel therapy, pilates
- Keywords
- manipulation, pilates, spinal problems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manuel therapyBehavioural
Also called chriopractic, osteopathic manual therapy, pilates, reformer
The Pilates program performed by the participants was as follows:
Footwork Series, Running, Pelvic Lift, Bridge, Bridge Pose Flow, Squat, Coordination, The Hundred Twist Stomach, Leg Circles, Frog, Rowing Front Sitting Tall, T-Pull (Long Box Series), Pulling The Straps, Short Box Series, Elephant, Side Stretch, Footwork Series
The manual therapy program included:
cervical, thoracic, and lumbar manipulation, upper and lower extremity manipulation, and temporomandibular joint manipulation.
pilatesOther
Also called exercise, flexibility, balance training
The Pilates program performed by the participants was as follows:
Footwork Series, Running, Pelvic Lift, Bridge, Bridge Pose Flow, Squat, Coordination, The Hundred Twist Stomach, Leg Circles, Frog, Rowing Front Sitting Tall, T-Pull (Long Box Series), Pulling The Straps, Short Box Series, Elephant, Side Stretch, Footwork Series
| Study group | Role | What they receive |
|---|---|---|
| group 1: MT | Active comparator | Manual Therapy Group:
20 people meeting the inclusion criteria were accepted. Participants received Pilates sessions twice a week, with two days between sessions. A total of 8 sessions (4 weeks) were conducted. Manual therapy was performed after each 50-minute exercise session. Receives: Behavioral: manuel therapy; Other: pilates |
| group 2: control group | Other | 20 people meeting the inclusion criteria were accepted. Participants received Pilates sessions twice a week, with two days between sessions. A total of 8 sessions (4 weeks) were conducted Receives: Other: pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale (SF-36)
The SF-36 (Short Form) was used to assess participants' quality of life. It consists of a total of 36 items, including subgroups. The three major health domains included in the SF-36 are functional status, well-being, and general perception of health. These are: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general perception of health (5 items). An average score was calculated for each section. Scores for each section range from 0 to 100, with higher scores indicating better quality of life. Participants were asked to carefully read the questions and answer each question considering their current and past health status. Higher scores indicate higher quality of life. The Turkish version of this questionnaire was used in our study.
Measured: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
Y Balance Test
During the Y-balance test, it was emphasized that participants should be barefoot. Throughout the test, athletes were encouraged to stand on one leg and reach the maximum distance they could with the other leg in the anterior, posterolateral, and posteromedial directions. The test device was configured with an angle of 135° between the anterior and posterior directions, and 90° in the posterior direction. To increase the reliability of the test and reduce the learning effect, each athlete performed at least six trials with each leg. To minimize the effect of fatigue, during the actual test, three repetitions were performed in the anterior direction, followed by three repetitions each in the posteromedial and posterolateral directions with each leg. If athletes touched the ground with their other foot to maintain balance, did not return to the starting position, or removed their hands from their hips to maintain balance, the relevant trial was considered erroneous and invalidated. The
Measured: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
Flexibility Tests
Flexibility Tests
Sit-and-reach test: Performed with a standard bench with a 0-50 cm measuring scale, the top surface of which is 15 cm further out than where the feet rest.
Trunk Hyperextension: The starting value is taken by measuring the distance between the wall and the sternal notch. With pelvic support, the patient is asked to push their torso backward from the waist. The distance between the sternal notch and the wall is measured again, and the starting value is subtracted from this value to record the amount of movement in centimeters.
Trunk Lateral Flexion: The distal end of the toe finger is marked on the thigh, then the patient is asked to slide their hand down the thigh and tilt their torso to the side.
Cervical rotation: The patient sits, a long stick is placed in their mouth and squeezed. The pivot point is placed in the middle of the head, the fixed arm is parallel to the floor. The movable arm follows the stick held in their mouth.
Measured: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
Secondary outcomes (1)
VISUAL ANALOG SCALE
The VAS is typically presented as a 10 cm line supported by verbal descriptors such as 'no pain' and 'worst imaginable pain'. The patient is asked to mark a 100 mm line to indicate pain intensity. The score is measured from the zero point to the patient's mark. An increase in the numerical score indicates increased pain among the volunteers participating in the study, while a decrease in the score indicates decreased pain.
Measured: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start10 Apr 2025
- Primary completion28 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manipulation, OsteopathicStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Özufacık, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466368
- Sponsor's protocol ID
- IstanbulRumeliU-FTR-MÖ-01
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the laws of the Republic of Türkiye, sharing personal data is prohibited.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFORMER YAPAN NON-SPESİFİK OMURGA PROBLEMLİ OLGULARDA MANİPÜLASYONUN ETKİSİNİN DEĞERLENDİRİLMESİ
- ClinicalTrials.gov ID
- NCT07466368
- Acronym / sponsor ID
- IstanbulRumeliU-FTR-MÖ-01
- Keywords
- manipulation, pilates, spinal problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 12 Mar 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.
Participants were randomly divided into two groups: a Pilates group (n=20) and a Pilates and spine-total body manipulation group (n=20). Both groups received a total of 8 sessions, 2 days a week, for 50 minutes each; one group received only Pilates, while the other group received Pilates combined with spine-total body manipulation.
Detailed description
A study is planned at the LoveYour Body Healthy Living Center in Gaziantep, involving 20 clients with spinal problems who will receive 8 sessions of reformer pilates alone (2 days a week, 50 minutes each) and another 20 clients who will receive 8 sessions of reformer pilates and spinal-total body manipulation (2 days a week, 50 minutes each). The sample size was determined through a power analysis using a 5% significance level (α = 0.05), a moderate effect size (effect size = 0.5), and 80% test power (power = 0.80). The analysis, conducted using the G*Power program, calculated that a minimum of 35 participants is required. Participation in the study was voluntary, and initial assessments were conducted on the same day. Participants were defined as being over 18 years of age, volunteering to participate, and experiencing at least one of the following symptoms for at least 4 weeks: non-specific mechanical lower back pain, non-specific mechanical neck pain, non-specific spinal problems, or pain in the neck and shoulder girdle region, or diagnosed with myofascial pain syndrome. Exclusion included pregnant women, those with acute lower back and neck pain, those who had recently undergone surgery, those with idiopathic scoliosis, vertigo, or bone disease, those with a positive vertebral artery test, those using cortisone, and those who had been practicing Pilates for more than 3 months. Assessments were conducted on the day participants began and the day the program ended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: MT | Active comparator | Behavioral: manuel therapy, Other: pilatesManual Therapy Group: 20 people meeting the inclusion criteria were accepted. Participants received Pilates sessions twice a week, with two days between sessions. A total of 8 sessions (4 weeks) were conducted. Manual therapy was performed after each 50-minute exercise session. |
| group 2: control group | Other | Other: pilates20 people meeting the inclusion criteria were accepted. Participants received Pilates sessions twice a week, with two days between sessions. A total of 8 sessions (4 weeks) were conducted |
Who may qualify
- Ages
- 18 to 70 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Ability to communicate in Turkish
- Willingness to participate in the study
- Non-specific mechanical lower back pain
- Non-specific mechanical neck pain
- Non-specific spinal problems
Key exclusion criteria (10 listed)
- Pregnancy
- Acute lower back pain
- Acute neck pain
- Recent surgery
- Idiopathic scoliosis
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 |
|---|---|---|
| manuel therapyAlso: chriopractic, osteopathic manual therapy, pilates, reformerThe Pilates program performed by the participants was as follows: Footwork Series, Running, Pelvic Lift, Bridge, Bridge Pose Flow, Squat, Coordination, The Hundred Twist Stomach, Leg Circles, Frog, Rowing Front Sitting Tall, T-Pull (Long Box Series), Pulling The Straps, Short Box Series, Elephant, Side Stretch, Footwork Series The manual therapy program included: cervical, thoracic, and lumbar manipulation, upper and lower extremity manipulation, and temporomandibular joint manipulation. | Behavioural | group 1: MT |
| pilatesAlso: exercise, flexibility, balance trainingThe Pilates program performed by the participants was as follows: Footwork Series, Running, Pelvic Lift, Bridge, Bridge Pose Flow, Squat, Coordination, The Hundred Twist Stomach, Leg Circles, Frog, Rowing Front Sitting Tall, T-Pull (Long Box Series), Pulling The Straps, Short Box Series, Elephant, Side Stretch, Footwork Series | Other | group 1: MT, group 2: control group |
Primary outcome
Quality of Life Scale (SF-36)
Time frame: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
The SF-36 (Short Form) was used to assess participants' quality of life. It consists of a total of 36 items, including subgroups. The three major health domains included in the SF-36 are functional status, well-being, and general perception of health. These are: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general perception of health (5 items). An average score was calculated for each section. Scores for each section range from 0 to 100, with higher scores indicating better quality of life. Participants were asked to carefully read the questions and answer each question considering their current and past health status. Higher scores indicate higher quality of life. The Turkish version of this questionnaire was used in our study.
Y Balance Test
Time frame: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
During the Y-balance test, it was emphasized that participants should be barefoot. Throughout the test, athletes were encouraged to stand on one leg and reach the maximum distance they could with the other leg in the anterior, posterolateral, and posteromedial directions. The test device was configured with an angle of 135° between the anterior and posterior directions, and 90° in the posterior direction. To increase the reliability of the test and reduce the learning effect, each athlete performed at least six trials with each leg. To minimize the effect of fatigue, during the actual test, three repetitions were performed in the anterior direction, followed by three repetitions each in the posteromedial and posterolateral directions with each leg. If athletes touched the ground with their other foot to maintain balance, did not return to the starting position, or removed their hands from their hips to maintain balance, the relevant trial was considered erroneous and invalidated. The
Flexibility Tests
Time frame: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
Flexibility Tests Sit-and-reach test: Performed with a standard bench with a 0-50 cm measuring scale, the top surface of which is 15 cm further out than where the feet rest. Trunk Hyperextension: The starting value is taken by measuring the distance between the wall and the sternal notch. With pelvic support, the patient is asked to push their torso backward from the waist. The distance between the sternal notch and the wall is measured again, and the starting value is subtracted from this value to record the amount of movement in centimeters. Trunk Lateral Flexion: The distal end of the toe finger is marked on the thigh, then the patient is asked to slide their hand down the thigh and tilt their torso to the side. Cervical rotation: The patient sits, a long stick is placed in their mouth and squeezed. The pivot point is placed in the middle of the head, the fixed arm is parallel to the floor. The movable arm follows the stick held in their mouth.
1 secondary outcome
VISUAL ANALOG SCALE
Time frame: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation
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 16 Mar 2026.
- Individual participant dataSharing planned: No. According to the laws of the Republic of Türkiye, sharing personal data is prohibited.
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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.
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 manuel therapy and pilates in people with Manipulation, Osteopathic and Pilates Exercise, run by Istanbul Rumeli 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 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: finished, as of the sponsor's last update on 16 Mar 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?
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?
Quality of Life Scale (SF-36) (time frame: I. evaluation: on the first day of inclusion in the study II. evaluation: after a total of 8 sessions of application, 2 days a week, in the 4th week according to the first evaluation). The study lists 3 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 16 Mar 2026.