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RecruitingNCT06706037Updated Nov 26, 2024

Effect of Reformer Exercises on Pain Perception in Chronic Musculoskeletal Pain.

An interventional study of Exercise in Musculoskeletal Pain, sponsored by Atılım University. Recruiting at 1 site in Turkey. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Atılım University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Musculoskeletal Pain

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Keywords

  • chronic pain
  • musculoskeletal pain
  • reformer pilates
03

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Sedantry male and female aged 30-50 years chronic musculoskeletal pain diagnosed for at least 6 months

Exclusion criteria

Exclusion Criteria:

neurological disorders communication and psychiatric disorders

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    reformer exercise grup

    Reformer exercise group will receive a 6-week reformer pilates exercise.

    Other: Exercise

  • 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.

Interventions

  • OtherExercise

    A 6 week reformer pilates exercise program

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to one month

  2. 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).

    Time frame: Up to one month

  3. 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.

    Time frame: 1month

Secondary outcomes

  1. 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

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

  3. 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.

    Time frame: 1 month

06

Study locations

1 of 1 sites recruiting
  • Naime Ulug
    Ankara, Select State 06830, Turkey
    Recruiting
07

Registry details

Key details

Study ID
NCT06706037
Lead sponsor
Atılım University
Collaborators
Çankırı Karatekin University
Responsible party
NAİME ULUG (Assistant Professor, Atılım University) — Principal investigator
First posted
Nov 26, 2024
Start date
Sep 27, 2024
Primary completion
Nov 30, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Nov 26, 2024

Study contacts

Naime Uluğ, PT,PhD
Contact
ulugnaime@gmail.com
05365434409
Nilay Şahan, PT,PhD
Contact
nilaysahan@gmail.com
+90 505 467 10 90
Nilay Şahan
principal investigator · Çankırı KaratekinvUniversity, Ankara/TURKEY

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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