NCT06706037

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

October 8, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

chronic painmusculoskeletal painreformer pilates

Outcome Measures

Primary Outcomes (3)

  • 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

    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).

    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.

    1month

Secondary Outcomes (3)

  • Kinesiophobia assessment by Tampa Kinesiophobia Scale

    1 month

  • Fatigue assessment by Functional Assessment of Chronic Illness Therapy.

    1 month

  • Sleep quality assessment

    1 month

Study Arms (2)

reformer exercise grup

EXPERIMENTAL

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

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.

Interventions

A 6 week reformer pilates exercise program

reformer exercise grup

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • neurological disorders communication and psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naime Ulug

Ankara, Select State, 06830, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Musculoskeletal PainChronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nilay Şahan

    Çankırı KaratekinvUniversity, Ankara/TURKEY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naime Uluğ, PT,PhD

CONTACT

Nilay Şahan, PT,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study participants were made to exercise for 6 weeks, but they were not informed about the purpose of the study and evaluation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective cross-sectional randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 8, 2024

First Posted

November 26, 2024

Study Start

September 27, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations