Clinical trial NCT05689593: Comparison of Low-intensity Extracorporeal Shockwave Therapy and Low-intensity Laser Effects in Adhesive Capsulitis
Official title: Comparison of the Efficiency of Low Intensity Extracorporeal Shock Wave Therapy and Low Intensity Laser Therapy in Adhesive Capsulitis Treatment: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Rehabilitation
extracorporeal shock wave therapy
low-level laser therapy
pain
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with a conventional therapy control group
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate whether they are superior to the control group.

Detailed description: In this study, 60 adhesive capsulitis with age range 18-65 who applied to Kırsehir Ahi Evran University Training and Research Hospital were examined.Adhesive capsulitis is also called arthrofibrosis, which involves excessive adhesion formation along the glenohumeral joint. It is a disease of unknown etiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis, central nervous system involvement, arm immobilized for a long time, trauma or fracture, infectious diseases, etc. Includes post-mortem situations.

Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.

low-level laser therapy supports cell proliferation and tissue regeneration with its anti-inflammatory and photobiostimulation properties.The pressure waves of ESWT pass through fluids and soft tissues and exert their effects in areas of impedance change such as bones and soft tissue spaces. These waves have mechanical and cellular effects. The most important of these effects are temporary damage to the neuronal cell membrane or increased permeability. These mechanisms may facilitate neovascularization and cellular regeneration in tissues.

Eligibility criteria: Inclusion Criteria:

* male and female patients who have received "adhesive capsulitis" by clinical and examination
* Patients with loss of range of motion in the capsular pattern (external rotation \> abduction \> internal rotation) will be included in the study.
* Patients who consent to participate in the study according to the informed consent form will be included in the study.

Exclusion Criteria:

* Upper extremity injury in the last 6 months
* Shoulder injection in the last 6 months
* Existing open wound in the upper extremity area
* Prior upper extremity surgery
* The patient has a systemic infection
* Uncontrolled hypertension in the patient
* Inability of the patient to cooperate
* The patient's unwillingness to participate in the study
* The patient has a malignancy

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 0. week
measure: Visual analogue scale (VAS)
timeFrame: 3. week
measure: Visual analogue scale (VAS)
timeFrame: 12. week
measure: CONSTANT (MURLEY) SCORE (CS)
timeFrame: 0. week
measure: CONSTANT (MURLEY) SCORE (CS)
timeFrame: 3. week
measure: CONSTANT (MURLEY) SCORE (CS)
timeFrame: 12.week
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 0. week
measure: Pittsburgh Sleep Quality Index
timeFrame: 3. week
measure: Pittsburgh Sleep Quality Index
timeFrame: 12. week
measure: The Short Form Health Survey (SF-36)
timeFrame: 0. week
measure: The Short Form Health Survey (SF-36)
timeFrame: 3. week
measure: The Short Form Health Survey (SF-36)
timeFrame: 12. week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran Üniversitesi
state: Central Anatolia
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: ismail Ceylan, PhD
role: PRINCIPAL_INVESTIGATOR
References: