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出境医 / 临床实验 / Laser Therapy in Adhesive Capsulitis

Laser Therapy in Adhesive Capsulitis

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.

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 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
Actual Primary Completion Date : September 22, 2019
Actual Study Completion Date : September 22, 2019
Arms and Interventions
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
Device: Shame laser & exercises
Sham laser treatment (the same device to be used, 0 watts) will be given.

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.

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.

Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Turkey
Tuğba Atan
Corum, Turkey, 19100
Sponsors and Collaborators
Hitit University
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 28, 2020
Actual Study Start Date  ICMJE April 22, 2019
Actual Primary Completion Date September 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • 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.
  • 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).
  • Range of motion of shoulder joint measurements [ Time Frame: 2 weeks ]
    shoulder flexion, abduction, external rotation and internal rotation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Therapy in Adhesive Capsulitis
Official Title  ICMJE Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adhesive Capsulitis of Shoulder
Intervention  ICMJE
  • 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.
  • Device: Shame laser & exercises
    Sham laser treatment (the same device to be used, 0 watts) will be given.
  • 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.
Study Arms  ICMJE
  • Experimental: high-intensity laser therapy & exercises
    High-intensity laser therapy application with iLux Laser device + exercise program
    Interventions:
    • Device: high-intensity laser therapy & exercises
    • Other: exercise
  • Placebo Comparator: Shame laser & exercises
    Sham high-intensity laser therapy application with iLux Laser device + exercise program
    Interventions:
    • Device: Shame laser & exercises
    • Other: exercise
  • Active Comparator: control - exercises only group
    exercise program
    Intervention: Other: exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
54
Actual Study Completion Date  ICMJE September 22, 2019
Actual Primary Completion Date September 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929276
Other Study ID Numbers  ICMJE 19-KAEK-061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tuğba Atan, Hitit University
Study Sponsor  ICMJE Hitit University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hitit University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP