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Completed

NCT Number: NCT03498859

Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

This study investigates the efficacy of physiotherapist-supervised training once per week during 10 weeks compared to home-based training during 10 weeks, after proksimal humerus fracture.

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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Viborg Regional Hospital, Viborg, Denmark

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About this study

Proximal humerus fracture is the third most common fracture in elderly people after hip and colles fracture, and are often caused by fall and osteoporosis. These fractures are highly related to morbidity and mortality among elderly people and consumes considerably health care resources. More than 70% of the proximal humerus fracture patients are over 60 years of age and 75% are female.

Only sparse evidence reveals to what extend the patients need rehabilitation and how it should be implemented in the treatment strategy.

In Denmark as well as in Finland the rehabilitation after proximal humerus fractures takes place in local centers in the municipalities, and the rehabilitation offered to the patients varies significantly. Currently in Denmark there are no national clinical guidelines to support the rehabilitation strategy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

•Low energy proximal humeral displaced (more than 5mm or 30 degrees) two-part fracture where fracture line emerges through the surgical (or anatomical) neck, treated non-operatively

Exclusion criteria

  • Refuse to participate in the study
  • Younger than 60 years old
  • Non-independent
  • Demented
  • Does no understand written and spoken guidance in local language
  • Pathological fracture or previous fracture in the same proximal humerus
  • Other operational injuries in the same upper limb
  • Major nerve injury (e.g. Complete radialis- or delta palsy)
  • Open fracture
  • Multi-trauma patient
  • Fracture dislocation or head splitting fracture
  • Undisplaced fracture
  • Isolated tuberculum fracture
  • Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
  • Treating surgeon considers patient unsuitable to attend the study on medical basis

Treatment and study plan

Physiotherapist-supervised training

Other

The intervention is physiotherapist-supervised training once per week during 10 weeks.

Home-based training

Other

The intervention is home-based training during 10 weeks

Primary outcomes

  1. The Disability of the Arm, Shoulder and Hand (DASH)

    Time frame: Measured at 3 months after fracture

    Patient reported outcome measure of physical function in the upper extremity. Measures on a 0-100 scale, where a higher score indicates greater disability.

    The scores will be compared between the 2 groups

Secondary outcomes

  1. The Disability of the Arm, Shoulder and Hand (DASH)

    Time frame: Measured at baseline and after 12 months

    Patient reported outcome measure of physical function in the upper extremity. Measures on a 0-100 scale, where a higher score indicates greater disability.

    The scores will be compared between the 2 groups

  2. Constant Murley Shoulder Score

    Time frame: Measured after 3 and 12 months.

    Subjective and objective measurement of the shoulder function. Measures on a 0-100 scale, where a lower score indicates greater disability. The scores will be compared between the 2 groups

  3. 15-dimentional health-realted quality of life instrument (15D)

    Time frame: Measured at baseline, after 3 and 12 months

    Patient reported outcome measure of health related quality of life. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale, where a higher score indicates a poor health related quality of life.

    The scores will be compared between the 2 groups

  4. Pain catastrophizing Scale

    Time frame: Measured at baseline, after 3 and 12 months

    Patient reported outcome measure. Measures on a 0-53 scale, where a higher score indicates a higher levels of pain catastrophizing thinking.

    The scores will be compared between the 2 groups. Also the correlation with DASH scores will be investigated

  5. Generel Self-Efficacy scale

    Time frame: Measured at baseline, after 3 and 12 months

    Patient reported outcome measure. Measures on a 10-40 scale, where a higher score indicates a higher degree of self-efficacy.

    The scores will be compared between the 2 groups. Also the correlation with DASH scores will be investigated

  6. Accelerometer based activity in the upper extremity

    Time frame: Measured at 3 and 12 months

    The patient is wearing a censor above the elbow on both arms, that measures the level of upper extremity activity for three consecutive days. It measures the number of movements under and above shoulder hight and classify them into either high or low intensity movements.

    The asymmetry between the fractured and the healthy arm will be estimated and compared between the groups.

Other outcomes

  1. Follow up of the decliners

    Time frame: Measured at baseline and 3 months

    Patients declining to participate in the randomised trial will be invited to follow up visits, consisting of x-rays and identical questionnaires as used in the RCT

  2. Cost-effectiveness

    Time frame: After 12 months

    A cost-effectiveness analysis (QALY) of the two training modalities will be performed and a ratio will be estimated.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Oslo University Hospital
  • Regionshospitalet Viborg, Skive
  • Tampere University Hospital

Registry information

Official study title

Efficacy of Physiotherapist-supervised Rehabilitation After Two-part Proximal Humerus Fractures Treated Non-operatively. A Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2018
Registry last updated
Jan 5, 2023

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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