The Effect of Cherry Seed Pillow on Fibromyalgia

NCT06171022 | Completed

• 1 other identifier: KaratatUH10
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain at 4 weeks

  he rest, activity and night pains of the participants will be evaluated with a 10 cm Visual Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.

  Baseline and 4 weeks

Secondary Outcomes (1)

• Change from baseline in function at 4 weeks

  Baseline and 4 weeks

Study Arms (2)

Cherry seed pillow

EXPERIMENTAL

4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a heated cherry seed pillow will be applied.

Other: Cherry seed pillow

Control

ACTIVE COMPARATOR

4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a hot-pack will be applied.

Other: Control

Interventions

Cherry seed pillow OTHER

4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of heated cherry seed pillow will be applied to the participant's back area.

Cherry seed pillow

Control OTHER

4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of hotpack will be applied to the participant's back area.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Over 18 years of age
• Diagnosis of Fibromyalgia according to ACR classification criteria
• Neuromuscular system examination is normal
• Pain (vas-visual anologous scale) level of at least 5 points
• No communication problems
• Willingness to participate in the practice of using cherry seed cushion
• To be capable of answering the data collection tools to be used in the research
• Not having made hot, cold etc. applications at home

You may not qualify if:

• No diagnosis of Fibromyalgia according to ACR classification criteria
• Normal examination of the neuromuscular system
• Pain (vas-visual anologous scale) level between 0-5
• Communication problems
• Failure to accept the practice of using cherry seed cushion and failure to finish the implementation process
• Having a musculoskeletal disorder other than fibromyalgia
• Pregnant or lactating
• To be capable of answering the data collection tools to be used in the research
• Having made hot, cold etc. applications at home

Sponsors & Collaborators

• Hasan Gerçek: lead

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: December 6, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 10, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)