The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia

NCT ID: NCT06277375

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2024-03-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Massage

Intervention Type: BEHAVIORAL

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.

Control Group

No intervation. Routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Massage

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Dilek Efe Arslan

ErciyesU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DİLEK EFE ARSLAN

Role: STUDY_DIRECTOR

ERCİYES UNİVERSİTY

Locations

Dilek Efe Arslan

Kayseri, Melikgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

813/793

Identifier Type: -

Identifier Source: org_study_id