- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277375
The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia
March 30, 2026 updated by: Dilek Efe Arslan, TC Erciyes University
Fibromiyalji Tanılı Kadınlarda Uygulanan Yavaş Vurumlu Sırt Masajının Ağrı ve Yorgunluk Üzerine Etkisi: Randomize Kontrolü Çalışma
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.
Study Overview
Detailed Description
he research will be conducted experimentally with the aim of evaluating the effects of slow-stroke back massage in patients followed up in the physical therapy and rehabilitation unit with the diagnosis of fibromyalgia.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Melikgazi
-
Kayseri, Melikgazi, Turkey (Türkiye), 38280
- Dilek Efe Arslan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Slow stroke back massage
The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes.
|
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.
|
|
No Intervention: Control Group
No intervation. Routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS
Time Frame: The scale was filled in the baseline
|
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
Time Frame: The scale was filled in the baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: DİLEK EFE ARSLAN, Erciyes University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2023
Primary Completion (Actual)
September 15, 2023
Study Completion (Actual)
March 25, 2026
Study Registration Dates
First Submitted
February 19, 2024
First Submitted That Met QC Criteria
February 19, 2024
First Posted (Actual)
February 26, 2024
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Rheumatic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Fibromyalgia
- Fatigue
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
Other Study ID Numbers
- 813/793
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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