Laser Therapy in Adhesive Capsulitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2019-09-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adhesive Capsulitis of Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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high-intensity laser therapy & exercises

High-intensity laser therapy application with iLux Laser device + exercise program

Group Type EXPERIMENTAL

high-intensity laser therapy & exercises

Intervention Type DEVICE

A total of 15 sessions of high-dose laser treatment- i Lux Laser (Mectronic Medicale, Italy)- (in the first phase, 8 Watt for the analgesic effect; in the second phase, 12 Watt in burst mode for the biostimulation effect; and finally in the third phase with 8 Watt) will be applied.

exercise

Intervention Type OTHER

Therapeutic exercises All participants received 25-minutes of passive stretching, active assisted range of motion and codman pendicular exercises (10 repetitions, 3 sets, 3-minutes rest between sets) to the shoulder joint, supervised by the same physiotherapist five times a week for 3 weeks.

Shame laser & exercises

Sham high-intensity laser therapy application with iLux Laser device + exercise program

Group Type PLACEBO_COMPARATOR

Shame laser & exercises

Intervention Type DEVICE

Sham laser treatment (the same device to be used, 0 watts) will be given.

exercise

Intervention Type OTHER

Therapeutic exercises All participants received 25-minutes of passive stretching, active assisted range of motion and codman pendicular exercises (10 repetitions, 3 sets, 3-minutes rest between sets) to the shoulder joint, supervised by the same physiotherapist five times a week for 3 weeks.

control - exercises only group

exercise program

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

Therapeutic exercises All participants received 25-minutes of passive stretching, active assisted range of motion and codman pendicular exercises (10 repetitions, 3 sets, 3-minutes rest between sets) to the shoulder joint, supervised by the same physiotherapist five times a week for 3 weeks.

Interventions

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high-intensity laser therapy & exercises

A total of 15 sessions of high-dose laser treatment- i Lux Laser (Mectronic Medicale, Italy)- (in the first phase, 8 Watt for the analgesic effect; in the second phase, 12 Watt in burst mode for the biostimulation effect; and finally in the third phase with 8 Watt) will be applied.

Intervention Type DEVICE

Shame laser & exercises

Sham laser treatment (the same device to be used, 0 watts) will be given.

Intervention Type DEVICE

exercise

Therapeutic exercises All participants received 25-minutes of passive stretching, active assisted range of motion and codman pendicular exercises (10 repetitions, 3 sets, 3-minutes rest between sets) to the shoulder joint, supervised by the same physiotherapist five times a week for 3 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No