Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures

Fracture of Femur Clinical Trial

Official title:

Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018610
• Other study ID #: Kalça kirigi
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Mugla Sitki Koçman University
• Contact: Fatih Özden, PhD
• Phone: 543 433 4593
• Email: fatihozden[@]mu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 1, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery
• No medical contraindications that would limit the ability to exercise
• Having a caregiver who can supervise the exercise program after discharge
• To be able to understand simple commands and to have signed the consent form

Exclusion Criteria:

• Patients with pathological fractures and/or multiple fractures
• Those with serious early complications
• Terminally ill patients
• Circumstances that would interfere with conducting assessments or communicating
• Lack of cooperation during the study
• Scoring =14 on the Mini Mental State Examinatio

Related Conditions & MeSH terms

• Femoral Fractures
• Fracture of Femur
• Fractures, Bone

Intervention

Other:
• Rehabilitation
In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.
• Control
Conventional rehabilitation will be applied to the control group.

Locations

Country	Name	City	State
Turkey	Fethiye State Hospital	Mugla	Fethiye
Turkey	Mugla Sitki Koçman Training and Research Hospital	Mugla	Mentese

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).	Change from Baseline VAS at 3 days
Primary	Barthel Index (BI)	The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.	Change from Baseline BI at 3 days
Primary	EQ-5D-3L Quality of Life Scale	The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".	Change from Baseline EQ-5D-3L at 3 days
Primary	Hospital Anxiety and Depression Scale (HADS)	The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered "normal", 8 to 10 "mild", 11 to 14 "moderate" and 15 to 21 "severe".	Change from Baseline HADS at 3 days
Primary	Tampa Scale for Kinesiophobia (TSK)	The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.	Change from Baseline TSK at 3 days
Primary	Nottingham Hip Fracture Score (NHFS)	The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.	Change from Baseline NHFS at 3 days
Primary	Sole sensory testing with Semmes-Weinstein Monofilament	The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.	Change from Baseline Semmes-Weinstein Monofilament Test at 3 days