Laser Therapy in Adhesive Capsulitis

Not Applicable

Completed

• Conditions: Adhesive Capsulitis of Shoulder

• Registration Number: NCT03929276
• Lead Sponsor: Hitit University

Brief Summary

Adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. Shoulder pain and stiffness are accompanied by disability. The purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

Detailed Description

Adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3% to 5% in the general population and 20% in people with diabetes. Although usually reported to be self-limiting in 2 to 3 years, studies have reported that 40% of patients have persistent pain and stiffness for more than 3 years.

Therefore, various therapies are used to reduce pain and increase the range of motion more rapidly without waiting for spontaneous recovery. Adhesive capsulitis treatment includes conservative and surgical treatment options. The options for non-surgical treatments are pharmacological treatments including intra-articular injection and physical therapy modalities. As for physical therapy modalities, various interventions are used. These include heat or ice, therapeutic ultrasound, transcutaneous electrical nerve stimulation and laser therapies.

The aim of exercise programs consisting of joint range of motion (ROM), strengthening and stretching exercises, proprioceptive neuromuscular facilitation and mobilization techniques is to alleviate pain caused by the capsular contracture and to improve glenohumeral ROM.

The purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Primary Completion: 2019-09-22
• Study Completion: 2019-09-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-26
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Subjects with adhesive capsulitis diagnosis by physical examination (Compared with intact side, there is more than 25% limitation in at least two directions of shoulder range of motion)
• Subjects have complaints for at least 1 month
• No pregnancy / breastfeeding

Exclusion Criteria

• History of bilateral adhesive capsulitis
• History of shoulder trauma, fracture, shoulder shoulder surgery, calcific tendinopathy, glenohumeral osteoarthritis, inflammatory rheumatic diseases, tumor, infection
• History of corticosteroid injection in the shoulder during the last 3 months
• History of recent lung, breast or bypass surgery
• History of cervical radiculopathy / brachial plexus lesion
• History of neuromuscular disease
• History of physical therapy program for the same shoulder in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analogue scale for pain (VAS- pain)	2 weeks	Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

Secondary Outcome Measures

Name	Time	Method
Short Form Health Survey 36 (SF-36)	2 weeks	Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Shoulder pain and disability index	2 weeks	It is a self-administered questionnaire and two dimensions are measured, one for pain and the other for functional activities. Scores range from 0 to 100 with scores closer to 0 indicating lower (or no) disability and scores closer to 100 indicating greater disability.
Range of motion of shoulder joint measurements	2 weeks	shoulder flexion, abduction, external rotation and internal rotation

Trial Locations

Locations (1)

Tuğba Atan; 🇹🇷 Corum, Turkey