Slow and Accelerated Rehabilitation Protocols

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University

About this trial

Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

being in the age range of 18-65 years

being diagnosed with massive, irreparable rotator cuff tears based on magnetic resonance imaging and clinical continuity tests

symptoms are unresponsive to conservative care including steroid injections and physiotherapy for at least 6 months

having a good command of the Turkish language

Disqualifiers

diabetes mellitus

neurological problems

cervical disc herniation

visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Accelerated (ACCEL) protocol group

    Other intervention

    After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 8-week-long Phase 2 and Phase 3 trainings.

  • Slow (SLOW) protocol group

    Other intervention

    After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 14-week-long Phase 2 and Phase 3 trainings.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Accelerated (ACCEL) physiotherapy groupActive comparator 1 intervention
Group B: Slow (SLOW) physiotherapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual analog scale

Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Time frame
14 weeks
2

The Disabilities of the Arm, Shoulder and Hand Questionnaire

The Disabilities of the Arm, Shoulder and Hand Questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

Time frame
14 weeks
3

American Shoulder and Elbow Surgeons score

It is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

Time frame
14 weeks
4

Western Ontario Rotator Cuff Index

It has 21 items in four domains, including physical symptoms (ten questions), sports/recreation/work (four questions), lifestyle (four questions) and emotions (three questions). Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life due to pathological condition of the rotator cuff. Mathematic conversion yields a percentage score; higher percentages indicate proximity to normal function.

Time frame
14 weeks

Secondary outcomes

1

Catastrophizing

Pain Catastrophizing Scale will be used to evaluate the patient's feelings, thoughts, and emotions related to cognitive characteristics of pain. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points.

Time frame
14 weeks
2

Hospital Anxiety and Depression Scale

It will be used to assess anxiety and depression. It consists of 7 items for anxiety and 7 for depression. The items are scored on a 4-point scale from 0 (not present) to 3 (considerable).

Time frame
14 weeks
3

Tampa-Scale of Kinesiophobia

Participants will be assessed with Tampa-Scale of Kinesiophobia in terms of presence of kinesiophobia. The TSK is a 17-item scale that measures the somatic focus of patients (beliefs about underlying and serious medical problems), and activity avoidance (beliefs about (re) injury or increased pain). The TSK has moderate construct, concurrent and predictive validity, good internal consistency, and a moderate to good retest reliability. Patients scoring high on the TSK, above 37 points, are likely to have fear of movement.

Time frame
14 weeks
4

12-Item Short-Form Health Survey

Participants will be assessed with 12-Item Short-Form Health Survey in terms of quality of life. It is a self-administered survey and two scores can be measured: the Physical Component and the Mental Component. In both, scores range from 0 to 100, with the highest scores associated with better levels of quality of life.

Time frame
14 weeks

Other outcomes

Sponsors and contacts

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