Clinical trial NCT05678140: The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment
Official title: The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
ınstrument assısted Soft tıssue molılızatıon
Keywords: adhesıve capsulıtis
ınstrument assısted soft tıssue molılızatıon
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomızed controlled trıal
Primary purpose: TREATMENT

Brief summary: The primer aim of this study is to demonstrate the effect of instrument assisted soft tissue mobılızatıon on paın ,functıonality, joint range of motion patients with adhesive capsulitis

Detailed description: 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.

It is characterized by shoulder pain, decreased range of motion, and limitation of function. This affects the function of the entire upper extremity. Idiopathic adhesive capsulitis usually involves the non-dominant upper extremity, with bilateral involvement in 40-50% of cases. It is more common in women between the ages of 40 and 60. The incidence of adhesive capsulitis among the population is between 3% and 5%. It has been reported with up to 20% higher incidence in the diabetic population. It is also associated with other pathological disorders such as thyroid dysfunction, coronary artery disease and cerebrovascular disease. Although the pathology is self-limiting, long-term symptoms develop in approximately 20% to 50% of cases.

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

1. The painful phase lasts less than three months and presents with shoulder pain at night when glenohumeral movement is preserved.
2. The freezing process lasts three to nine months and is manifested by severe pain and stiffness in the glenohumeral joint.
3. The frozen shoulder process lasts nine to fourteen months and is eventually characterized by loss of motion and pain in all directions.
4. The resolution phase lasts for fifteen to twenty-four months and is characterized by persistent stiffness, minimal pain, and delayed improvement in shoulder motion.

Abnormal shoulder kinematics develops in response to the lack of extensibility of the capsule with the change in motor patterns in the central nervous system. Increased thoracic kyphosis can be seen as postural deviations. However, fibrotic changes are also seen in the periarticular connective tissue and trigger points. This presents as a higher level of disability with painful shoulder. Physiotherapy is the mainstay of treatment for patients with adhesive capsulitis. Joint mobilization has a proven role in conjunction with Codman's exercises. Transcutaneous Electrical Nerve Stimulation (TENS), Diathermy is used in the treatment to reduce pain. Instrument Assisted Soft Tissue Mobilization (IASTM) is a soft tissue mobilization method that works by generating localized inflammation and facilitates collagen synthesis and realignment. In fact, when IASTM is given to soft tissues with appropriate pressure, localized inflammation occurs with microvascular bleeding. This will increase blood flow to the injured area along with the recruitment of more fibroblasts. With the removal of scar tissues and adhesions, healing will be supported by the organization of collagen of fibroblasts. The fibronectin induced by IASTM is required for tissue repair. A localized force will be transmitted through an instrument to the affected tissues to leave a scar.

IASTM has become increasingly popular as a tool for the rehabilitation of sports injuries. It has been proven to be successful in a short time in reducing pain and increasing mobility after sports injuries. There are studies showing an increase in ROM after a single application of this technique.

It is known that it takes a long time to relieve pain and achieve a good improvement in ROM in adhesive capsulitis. This affects their quality of life and creates the need for treatment options that provide a shorter recovery time. Various conservative protocols are followed with physical therapy as the main treatment in adhesive capsulitis. Few studies have used IASTM as a treatment to evaluate its effect on adhesive capsulitis.

Eligibility criteria: Inclusion Criteria:

- 1.Male and Female patients aged 20-60 years 2.Diagnosed with adhesive capsulitis 2. Loss of range of motion in the capsular pattern (external rotation \> abduction \> internal rotation) will be included in the study.

3. consent to participate

Exclusion Criteria:

* 1. Injury to the upper extremity in the last 6 months 2. Shoulder injection in the last 6 months 3. Existing open wound in the upper extremity area 4. Previous upper extremity surgery 5. Being hypersensitive 6. Having a generalized infection 7. Having uncontrolled hypertension 8. Inability to cooperate; 9. The patient's unwillingness to participate in the study

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline
measure: Visual Analogue Scale (VAS)
timeFrame: 2. week (in the middle of treatment)
measure: Visual Analogue Scale (VAS)
timeFrame: 4. week (at the end of treatment)
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: baseline
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 2. week (in the middle of treatment)
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 4. week (at the end of treatment)
Secondary outcomes:
measure: joint range of motion
timeFrame: baseline
measure: joint range of motion
timeFrame: 2. week (in the middle of treatment)
measure: joint range of motion
timeFrame: 4. week (at the end of treatment)
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University Faculty of Medicine
state: City Center
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Basak Cigdem Karacay, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aggarwal A, Saxena K, Palekar TJ, Rathi M. Instrument assisted soft tissue mobilization in adhesive capsulitis: A randomized clinical trial. J Bodyw Mov Ther. 2021 Apr;26:435-442. doi: 10.1016/j.jbmt.2020.12.039. Epub 2020 Dec 31.
citation: Laudner K, Compton BD, McLoda TA, Walters CM. Acute effects of instrument assisted soft tissue mobilization for improving posterior shoulder range of motion in collegiate baseball players. Int J Sports Phys Ther. 2014 Feb;9(1):1-7.
citation: Hussey MJ, Boron-Magulick AE, Valovich McLeod TC, Welch Bacon CE. The Comparison of Instrument-Assisted Soft Tissue Mobilization and Self-Stretch Measures to Increase Shoulder Range of Motion in Overhead Athletes: A Critically Appraised Topic. J Sport Rehabil. 2018 Jul 1;27(4):385-389. doi: 10.1123/jsr.2016-0213. Epub 2018 Jun 1.