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Laser Therapy in Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
high-intensity laser therapy & exercises
Shame laser & exercises
exercise
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring adhesive capsulitis, high-intensity laser therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tuğba Atan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

high-intensity laser therapy & exercises

Shame laser & exercises

control - exercises only group

Arm Description

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

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

exercise program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Range of motion of shoulder joint measurements
shoulder flexion, abduction, external rotation and internal rotation

Full Information

First Posted
April 22, 2019
Last Updated
April 26, 2020
Sponsor
Hitit University
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1. Study Identification

Unique Protocol Identification Number
NCT03929276
Brief Title
Laser Therapy in Adhesive Capsulitis
Official Title
Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
September 22, 2019 (Actual)
Study Completion Date
September 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder
Keywords
adhesive capsulitis, high-intensity laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high-intensity laser therapy & exercises
Arm Type
Experimental
Arm Description
High-intensity laser therapy application with iLux Laser device + exercise program
Arm Title
Shame laser & exercises
Arm Type
Placebo Comparator
Arm Description
Sham high-intensity laser therapy application with iLux Laser device + exercise program
Arm Title
control - exercises only group
Arm Type
Active Comparator
Arm Description
exercise program
Intervention Type
Device
Intervention Name(s)
high-intensity laser therapy & exercises
Intervention Description
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
Intervention Name(s)
Shame laser & exercises
Intervention Description
Sham laser treatment (the same device to be used, 0 watts) will be given.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale for pain (VAS- pain)
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Shoulder pain and disability index
Description
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.
Time Frame
2 weeks
Title
Short Form Health Survey 36 (SF-36)
Description
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).
Time Frame
2 weeks
Title
Range of motion of shoulder joint measurements
Description
shoulder flexion, abduction, external rotation and internal rotation
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tuğba Atan
City
Corum
ZIP/Postal Code
19100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19468904
Citation
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.
Results Reference
background
PubMed Identifier
15373308
Citation
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.
Results Reference
background
PubMed Identifier
32808147
Citation
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.
Results Reference
derived

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Laser Therapy in Adhesive Capsulitis

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