NCT06277375

Brief Summary

Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

February 19, 2024

Last Update Submit

March 30, 2026

Conditions

Massage Intervention

Keywords

painFatigueFibromyalgia

Outcome Measures

Primary Outcomes (2)

  • VAS

    VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient.

    The scale was filled in the baseline

  • Fatigue

    It is a tenitem, self-administered questionnaire. Because each item has a maximum possible score of 10, the maximum possible total score is 100.

    The scale was filled in the baseline

Study Arms (2)

Slow stroke back massage

EXPERIMENTAL

The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes.

Behavioral: Massage

Control Group

NO INTERVENTION

No intervation. Routine care.

Interventions

MassageBEHAVIORAL

The application starts from the neck with small circular strokes with the thumbs. Surface strokes are performed with the palm of the hand from the base of the skull towards the sacral region. Then rhythmic strokes are repeated from the sacrum along the entire spine towards the skull.The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes.

Slow stroke back massage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to communicate verbally,
  • Over 18 years of age,
  • no vision and hearing loss
  • who have received medical treatment,
  • who have never received a slow-stroke back massage before

You may not qualify if:

  • Initially volunteered to participate in the study, but did not like the application of slow-stroke back massage
  • who wants to leave the study for another reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Efe Arslan

Kayseri, Melikgazi, 38280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainFatigueFibromyalgia

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • DİLEK EFE ARSLAN

    ERCİYES UNİVERSİTY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ErciyesU

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

February 14, 2023

Primary Completion

September 15, 2023

Study Completion

March 25, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

TU(1)