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Laser Therapy in Adhesive Capsulitis

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ClinicalTrials.gov Identifier: NCT03929276
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tuğba Atan, 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.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis of Shoulder Device: high-intensity laser therapy & exercises Device: Shame laser & exercises Other: exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : August 22, 2019
Estimated Study Completion Date : September 22, 2019

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
Passive stretching, active assisted range of motion exercises and codman pendicular exercises (10 repetitions, 2 sets) will be applied to the shoulder joint.

Placebo Comparator: Shame laser & exercises
Sham high-intensity laser therapy application with iLux Laser device + exercise program
Device: Shame laser & exercises
Sham laser treatment (the same device to be used, 0 watts) will be given.

Other: exercise
Passive stretching, active assisted range of motion exercises and codman pendicular exercises (10 repetitions, 2 sets) will be applied to the shoulder joint.

Active Comparator: control - exercises only group
exercise program
Other: exercise
Passive stretching, active assisted range of motion exercises and codman pendicular exercises (10 repetitions, 2 sets) will be applied to the shoulder joint.




Primary Outcome Measures :
  1. Visual analogue scale for pain (VAS- pain) [ Time Frame: 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 :
  1. Shoulder pain and disability index [ Time Frame: 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.

  2. Short Form Health Survey 36 (SF-36) [ Time Frame: 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).

  3. Range of motion of shoulder joint measurements [ Time Frame: 2 weeks ]
    shoulder flexion, abduction, external rotation and internal rotation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929276


Contacts
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Contact: Tuğba Atan, Assoc. Prof. +90 364 219 30 00 ext 4551 tubaatan@gmail.com

Locations
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Turkey
Tuğba Atan Recruiting
Corum, Turkey, 19100
Contact: Tuğba Atan, Assoc. Prof.    +905556679857    tubaatan@gmail.com   
Sponsors and Collaborators
Hitit University

Publications:
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Responsible Party: Tuğba Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT03929276     History of Changes
Other Study ID Numbers: 19-KAEK-061
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuğba Atan, Hitit University:
adhesive capsulitis
high-intensity laser therapy
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases