Musculoskeletal PainNCT06706037
Effect of Reformer Exercises on Pain Perception in Chronic Musculoskeletal Pain.
A study testing Exercise in people with Musculoskeletal Pain, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2024to 30 Nov 2024
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedantry male and female aged 30-50 years chronic musculoskeletal pain diagnosed for at least 6 months
Who cannot join
- neurological disorders communication and psychiatric disorders
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, 1 recruiting
- Recruiting
Naime Ulug
Ankara, Select State, 06830
NAİME ULUG, MsC, 05365434409, naime.ulug@atilim.edu.tr
Naime ULUG, PhD.
About this study
Official title: Do Reformer Pilates Exercises Change Pain Perception in Patients With Chronic Musculoskeletal Pain?A Comparative Study.
This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.
Read the detailed description
Although many symptoms are observed in musculoskeletal system disorders, pain which progresses gradually and even progresses to the point of causing incapacity for work is the most common. Although musculoskeletal system disorders indicate a very broad concept, it is also observed that low back, neck and back pain are in the first rank in studies conducted worldwide and in our country .Pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. Although there are many physical activity programmes, Pilates has become an increasingly widespread and recommended physical exercise method worldwide in recent years. The Pilates method is an exercise concept established by Joseph H Pilates in the early 1900s and currently applied to both sick and healthy individuals. Exercises can be performed on a mat and special equipment such as Cadillac, Reformer and Wundachair are also used. Pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. Therefore, although Pilates exercises are not designed to reduce body weight, they are a good option for sedentary, overweight and obese people who have difficulty in performing traditional exercises .
This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.
- Conditions
- Musculoskeletal Pain
- Being tested
- Exercise
- Keywords
- chronic pain, musculoskeletal pain, reformer pilates
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A 6 week reformer pilates exercise program
| Study group | Role | What they receive |
|---|---|---|
| reformer exercise grup | Experimental | Reformer exercise group will receive a 6-week reformer pilates exercise. Receives: Other: Exercise |
| control group | No intervention | The control group will consist of patients with chronic musculoskeletal pain waiting in the treatment list. No intervention method will be applied to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measurement by Brief Pain Inventory
Brief Pain Inventory: The questionnaire was developed by Cleeland and Ryan in 1994 . The pain intensity section of the BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain), whereas the functional interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference). A pain severity score is calculated from the mean of the four pain intensity items, and a pain interference score is calculated from the mean of the seven pain interference items
Measured: Up to one month
Pain coping assessment by Pain Coping Inventory.
Pain Coping Scale: The Pain Coping Questionnaire (PCQ) is a 39-item self-report measure for evaluating pain coping in children and adolescents in both clinical and research settings.16 It consists of 8 subscales that can be categorized into 3 higher-order factors, including approach (composed of information seeking, problem-solving, and seeking social support subscales), problem-focused avoidance (composed of positive self-statements, behavioural distraction, and cognitive distraction subscales), and emotion-focused avoidance (composed of externalizing and internalizing/catastrophizing subscales).
Measured: Up to one month
Pain beliefs assessment by Pain Beliefs Scale.
Pain Beliefs Scale: It was developed to evaluate the beliefs about the cause and treatment of pain in individuals with pain complaints.Pain beliefs and perceptions inventory (PBAPI).
The PBAPI was made up to 16 items selected from the piloted version of the PBAPI. Twelve of the items were selected to represent the factors found in the pilot study. Four additional items from the piloted version were included which demonstrated good internal consistency when piloted and which measured the degree to which pain is believed to be a mysterious experience. Each item was presented along with a 4-point Likert scale anchored at the hash marks with degrees of agreement or disagreement.
Measured: 1month
Secondary outcomes (3)
Kinesiophobia assessment by Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale: The Tampa Kinesiophobia Scale measures fear of movement/reinjury.Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: 1 month
Fatigue assessment by Functional Assessment of Chronic Illness Therapy.
FACIT Fatigue The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued).Score range is 0-52.Less than 30 score shows severe fatique.
Measured: 1 month
Sleep quality assessment
Pittsburg Sleep Quality Index: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 1 month
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 start27 Sep 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 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 Musculoskeletal 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
- prospective cross-sectional randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Principal investigator, NAİME ULUG, Atılım University
- Investigators
- Nilay Şahan, Principal investigator, Çankırı KaratekinvUniversity, Ankara/TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706037
- Sponsor's protocol ID
- Atılım2
- Status last verified
- Nov 2024
- First submitted
- 8 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sahan N, Ulug N, Ozeren A. Effects of reformer pilates on pain, psychological factors, and sleep in chronic musculoskeletal pain: a randomized controlled trial. BMC Psychol. 2025 Jul 26;13(1):836. doi: 10.1186/s40359-025-03207-9.
PubMed 40713915
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Reformer Pilates Exercises Change Pain Perception in Patients With Chronic Musculoskeletal Pain?A Comparative Study.
- ClinicalTrials.gov ID
- NCT06706037
- Acronym / sponsor ID
- Atılım2
- Conditions
- Musculoskeletal Pain
- Keywords
- chronic pain, musculoskeletal pain, reformer pilates
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Collaborators
- Çankırı Karatekin University
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- 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.
This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.
Detailed description
Although many symptoms are observed in musculoskeletal system disorders, pain which progresses gradually and even progresses to the point of causing incapacity for work is the most common. Although musculoskeletal system disorders indicate a very broad concept, it is also observed that low back, neck and back pain are in the first rank in studies conducted worldwide and in our country .Pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. Although there are many physical activity programmes, Pilates has become an increasingly widespread and recommended physical exercise method worldwide in recent years. The Pilates method is an exercise concept established by Joseph H Pilates in the early 1900s and currently applied to both sick and healthy individuals. Exercises can be performed on a mat and special equipment such as Cadillac, Reformer and Wundachair are also used. Pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. Therefore, although Pilates exercises are not designed to reduce body weight, they are a good option for sedentary, overweight and obese people who have difficulty in performing traditional exercises .
This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective cross-sectional randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| reformer exercise grup | Experimental | Other: ExerciseReformer exercise group will receive a 6-week reformer pilates exercise. |
| control group | No intervention | –The control group will consist of patients with chronic musculoskeletal pain waiting in the treatment list. No intervention method will be applied to the patients in the control group. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sedantry male and female aged 30-50 years chronic musculoskeletal pain diagnosed for at least 6 months
Key exclusion criteria (1 listed)
- neurological disorders communication and psychiatric disorders
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 |
|---|---|---|
| ExerciseA 6 week reformer pilates exercise program | Other | reformer exercise grup |
Primary outcome
Pain intensity measurement by Brief Pain Inventory
Time frame: Up to one month
Brief Pain Inventory: The questionnaire was developed by Cleeland and Ryan in 1994 . The pain intensity section of the BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain), whereas the functional interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference). A pain severity score is calculated from the mean of the four pain intensity items, and a pain interference score is calculated from the mean of the seven pain interference items
Pain coping assessment by Pain Coping Inventory.
Time frame: Up to one month
Pain Coping Scale: The Pain Coping Questionnaire (PCQ) is a 39-item self-report measure for evaluating pain coping in children and adolescents in both clinical and research settings.16 It consists of 8 subscales that can be categorized into 3 higher-order factors, including approach (composed of information seeking, problem-solving, and seeking social support subscales), problem-focused avoidance (composed of positive self-statements, behavioural distraction, and cognitive distraction subscales), and emotion-focused avoidance (composed of externalizing and internalizing/catastrophizing subscales).
Pain beliefs assessment by Pain Beliefs Scale.
Time frame: 1month
Pain Beliefs Scale: It was developed to evaluate the beliefs about the cause and treatment of pain in individuals with pain complaints.Pain beliefs and perceptions inventory (PBAPI). The PBAPI was made up to 16 items selected from the piloted version of the PBAPI. Twelve of the items were selected to represent the factors found in the pilot study. Four additional items from the piloted version were included which demonstrated good internal consistency when piloted and which measured the degree to which pain is believed to be a mysterious experience. Each item was presented along with a 4-point Likert scale anchored at the hash marks with degrees of agreement or disagreement.
3 secondary outcomes
Kinesiophobia assessment by Tampa Kinesiophobia Scale
Time frame: 1 month
Fatigue assessment by Functional Assessment of Chronic Illness Therapy.
Time frame: 1 month
Sleep quality assessment
Time frame: 1 month
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 26 Nov 2024.
- Derived from this study: PubMed 40713915Sahan N, Ulug N, Ozeren A. Effects of reformer pilates on pain, psychological factors, and sleep in chronic musculoskeletal pain: a randomized controlled trial. BMC Psychol. 2025 Jul 26;13(1):836. doi: 10.1186/s40359-025-03207-9.
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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.
Nilay Şahan principal investigator
Çankırı KaratekinvUniversity, Ankara/TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Musculoskeletal Pain, run by Atılım 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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?
Contact Naime Uluğ, PT,PhD (05365434409, ulugnaime@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measurement by Brief Pain Inventory (time frame: Up to one month). 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?
On the ClinicalTrials.gov record for NCT06706037, 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 26 Nov 2024.