Massage InterventionNCT06277375
The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia
A study testing Massage in people with Massage Intervention, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Massage Intervention
- What is being tested?
- Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2023to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Massage Intervention
- Being tested
- Massage
- Keywords
- pain, Fatigue, Fibromyalgia
- Medical subject headings
- Pain, Fatigue, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Massage |
| Control Group | No intervention | No intervation. Routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The scale was filled in the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start14 Feb 2023
- Primary completion15 Sep 2023
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massage InterventionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Efe Arslan, TC Erciyes University
- Investigators
- DİLEK EFE ARSLAN, Study director, ERCİYES UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277375
- Sponsor's protocol ID
- 813/793
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromiyalji Tanılı Kadınlarda Uygulanan Yavaş Vurumlu Sırt Masajının Ağrı ve Yorgunluk Üzerine Etkisi: Randomize Kontrolü Çalışma
- ClinicalTrials.gov ID
- NCT06277375
- Acronym / sponsor ID
- 813/793
- Conditions
- Massage Intervention
- Keywords
- pain, Fatigue, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow stroke back massage | Experimental | Behavioral: MassageThe application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. |
| Control Group | No intervention | –No intervation. Routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageThe 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. | Behavioural | Slow stroke back massage |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİLEK EFE ARSLAN study director
ERCİYES UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Massage Intervention, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: The scale was filled in the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.