Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures
Sponsor study identifier
interventional
40
1 country
2
Study Start
May 18, 2022
Actual (reported)Primary Completion
September 1, 2025
Actual (reported)Study Completion
October 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2022
Actual (reported)August 18, 2023
Actual (reported)August 30, 2023
Actual (reported)September 1, 2025
Actual (reported)October 1, 2025
Actual (reported)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
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
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
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
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
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
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
In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group. Patients will be re-evaluated 3 days after the completion of the interventions.
The control group will receive conventional rehabilitation practices (in and out of bed strengthening exercises, for 3 days).
In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.
Conventional rehabilitation will be applied to the control group.
Fethiye State Hospital
Muğla, Fethiye, Turkey (Türkiye)
Muğla Sıtkı Koçman Training and Research Hospital
Muğla, Menteşe, 48000, Turkey (Türkiye)
Ahmet İmerci, MD
Muğla Sıtkı Koçman University
Fatih Özden, PhD
Muğla Sıtkı Koçman University
Serkan Bakırhan, PhD
Ege University
İsmet Tümtürk, MSc
Süleyman Demirel University
40 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2023
First Posted
August 30, 2023
Study Start
May 18, 2022
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Fatih Özyer, MD
Fethiye State Hospital
Primary Completion
September 1, 2025
Actual (reported)Study Completion
October 1, 2025
Actual (reported)Last Updated
December 15, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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