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Completed

NCT Number: NCT06018610

Effectiveness of Relaxation and Massage Methods in Proximal Femur Fractures

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.

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Key information

Conditions

Fracture of Femur Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fethiye State Hospital, Muğla, Fethiye, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

In addition to conventional rehabilitation, relaxation exercises and classical massage of the sole of the foot will be applied to the study group.

Control

Other

Conventional rehabilitation will be applied to the control group.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Change from Baseline VAS at 3 days

    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).

  2. Barthel Index (BI)

    Time frame: Change from Baseline BI at 3 days

    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.

  3. EQ-5D-3L Quality of Life Scale

    Time frame: Change from Baseline EQ-5D-3L at 3 days

    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".

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from Baseline HADS at 3 days

    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".

  5. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Change from Baseline TSK at 3 days

    The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

  6. Nottingham Hip Fracture Score (NHFS)

    Time frame: Change from Baseline NHFS at 3 days

    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.

  7. Sole sensory testing with Semmes-Weinstein Monofilament

    Time frame: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days

    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.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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