Clinical trial NCT06631976: Conservative Treatment in Patients with Supraspinatus Tendon Injury.
Official title: Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients with Supraspinatus Tendon Injury.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supraspinatus Injury
Sleep Disturbance
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rotator cuff injuries are a major cause of severe pain, often significantly impacting patients\&#39; sleep quality. For patients waiting for surgery or those not eligible for operative treatment, conservative treatment is recommended. In cases of minor injuries, physiotherapy is as effective as surgical intervention.

The aim of this study is: (1) to compare the speed, effectiveness, and durability of four implemented interventions in improving sleep quality, pain, and shoulder function, (2) to select the most optimal form of conservative treatment for patients with shoulder pain affecting sleep quality, and (3) to evaluate the expression of brain-derived neurotrophic factor (BDNF) and proBDNF (precursor) at the mRNA protein level before the planned intervention (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after intervention.

The study results can assist physicians and physiotherapists in providing patients with therapy that not only relieves pain and improves function but also augments sleep quality, an aspect often overlooked in the literature yet greatly impacting patients\&#39; quality of life.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic partial incomplete thickness tear of the supraspinatus tendon, with a length below 1 cm and not exceeding 50% of the tendon thickness, confirmed by ultrasound examination.
2. Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score \> 5.
3. Shoulder pain disrupting the quality of sleep.
4. BMI \< 30.
5. Age 40-75.

Exclusion Criteria:

1. Other accompanying pain symptoms.
2. History of shoulder surgery.
3. Coexistence of psychiatric or neurological disorders.
4. Presence of comorbidities that may disrupt sleep.
5. Presence of risk factors impairing tissue regeneration and increasing the likelihood of injury progression - osteoporosis, diabetes, hypercholesterolemia.
6. Alcohol dependence, nicotine addiction, passive smoking.
7. Taking antibiotics from the fluoroquinolone group, sleep-affecting medications (such as melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics.
8. Lack of patient consent, lack of cooperation, or impaired verbal-logical communication.

Primary outcomes:
measure: Constant-Murley Score
timeFrame: 6 months
measure: Numeric pain Rating Scale
timeFrame: 6 months
measure: Range of motion measurements
timeFrame: 6 months
measure: Strength measurements
timeFrame: 6 months
measure: BDNF and proBDNF Assessment
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
Secondary outcomes:
measure: The Laitinen Pain Scale
timeFrame: 6 months
measure: The Simple Shoulder Test
timeFrame: 6 months
measure: The American Shoulder and Elbow Surgeons
timeFrame: 6 months
measure: Supraspinatous muscle echogenicity measurement
timeFrame: 6 months
measure: The assessment of the degree of fatty infiltration of the supraspinatus muscle
timeFrame: 6 months
measure: The Montreal Cognitive Assessment
timeFrame: 6 months
measure: The Trail Making Test
timeFrame: 6 months
measure: A 3D measurement of the Supraspinatus Injury
timeFrame: 6 months
measure: Ellman Classification of Partial-Thickness Rotator Cuff Tears
timeFrame: 6 months
measure: Athens Insomnia Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz
Study officials:
affiliation: Medical University of Lodz
name: Michał Kanak, MD
role: STUDY_CHAIR
affiliation: Medical University of Lodz
name: Marcin Domżalski, Prof.
role: STUDY_CHAIR
References: