Laser Therapy in Adhesive Capsulitis

Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Device: high-intensity laser therapy & exercises; Other: exercise; Device: Shame laser & exercises

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Corum, Turkey, 19100
    • Tuğba Atan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-intensity laser therapy & exercises; High-intensity laser therapy application with iLux Laser device + exercise program	Device: 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.; Other: 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.
Placebo Comparator: Shame laser & exercises; Sham high-intensity laser therapy application with iLux Laser device + exercise program	Other: 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.; Device: Shame laser & exercises; Sham laser treatment (the same device to be used, 0 watts) will be given.
Active Comparator: control - exercises only group; exercise program	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale for pain (VAS- pain)	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder pain and disability index	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.	2 weeks
Short Form Health Survey 36 (SF-36)	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).	2 weeks
Range of motion of shoulder joint measurements	shoulder flexion, abduction, external rotation and internal rotation	2 weeks

Collaborators and Investigators

• Sponsor: Hitit University

Publications and helpful links

General Publications

• Manske RC, Prohaska D. Diagnosis and management of adhesive capsulitis. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):180-9. doi: 10.1007/s12178-008-9031-6.
• Dudkiewicz I, Oran A, Salai M, Palti R, Pritsch M. Idiopathic adhesive capsulitis: long-term results of conservative treatment. Isr Med Assoc J. 2004 Sep;6(9):524-6.
• Atan T, Bahar-Ozdemir Y. Efficacy of high-intensity laser therapy in patients with adhesive capsulitis: a sham-controlled randomized controlled trial. Lasers Med Sci. 2021 Feb;36(1):207-217. doi: 10.1007/s10103-020-03121-z. Epub 2020 Aug 18.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): September 22, 2019
• Study Completion (Actual): September 22, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: adhesive capsulitis; high-intensity laser therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 19-KAEK-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No