- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06706037
Effect of Reformer Exercises on Pain Perception in Chronic Musculoskeletal Pain.
Do Reformer Pilates Exercises Change Pain Perception in Patients With Chronic Musculoskeletal Pain?A Comparative Study.
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Naime Uluğ, PT,PhD
- Phone Number: 05365434409
- Email: ulugnaime@gmail.com
Study Contact Backup
- Name: Nilay Şahan, PT,PhD
- Phone Number: +90 505 467 10 90
- Email: nilaysahan@gmail.com
Study Locations
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Select State
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Ankara, Select State, Turkey, 06830
- Recruiting
- Naime Ulug
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Contact:
- NAİME ULUG, MsC
- Phone Number: 05365434409
- Email: naime.ulug@atilim.edu.tr
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Principal Investigator:
- Naime ULUG, PhD.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Sedantry male and female aged 30-50 years chronic musculoskeletal pain diagnosed for at least 6 months
Exclusion Criteria:
neurological disorders communication and psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: reformer exercise grup
Reformer exercise group will receive a 6-week reformer pilates exercise.
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A 6 week reformer pilates exercise program
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No Intervention: control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity measurement by Brief Pain Inventory
Time Frame: Up to one month
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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
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Up to one month
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Pain coping assessment by Pain Coping Inventory.
Time Frame: Up to one month
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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).
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Up to one month
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Pain beliefs assessment by Pain Beliefs Scale.
Time Frame: 1month
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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. |
1month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia assessment by Tampa Kinesiophobia Scale
Time Frame: 1 month
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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
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1 month
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Fatigue assessment by Functional Assessment of Chronic Illness Therapy.
Time Frame: 1 month
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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.
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1 month
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Sleep quality assessment
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nilay Şahan, Çankırı KaratekinvUniversity, Ankara/TURKEY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Atılım2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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