The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
Primary Purpose
Pain Disorder, Low Level Laser Therapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-level laser therapy
High-intensity laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pain Disorder focused on measuring Adhesive capsulitis Pain, High-intensity laser therapy, Low-level laser therapy, Pain
Eligibility Criteria
Inclusion Criteria:
- patients aged between 25-65 years
- patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
- patients with severe pain and shoulder limitation for at least 3 months
- patients who are literate and able to understand verbal instructions in our language.
Exclusion Criteria:
- Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
- History of bilateral simultaneous adhesive capsulitis
- Recent history of lung, breast, or bypass surgery/radiotherapy
- History of corticosteroid injection to the same shoulder in the last 1 year
- History of cervical radiculopathy/brachial plexus lesion
- Neuromuscular disease history
- History of physical therapy program for the same shoulder in the last 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
low-level laser therapy
high-intensity laser therapy
Arm Description
LLLT will be performed 3 times a week for a period of 3 weeks
HILT will be performed 3 times a week for a period of 3 weeks
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3
This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Secondary Outcome Measures
Shoulder Pain and Disability Index
The severity of pain and limitation experienced by individuals during certain activities will be evaluated with the Shoulder Pain and Disability Index (SPADI). SPADI is an evaluation method filled by the individual, lasting approximately 5-10 minutes, which questions the state of pain and disability in the shoulder. [11] SPADI consists of 2 sections and 13 sub-headings, namely pain and disability. The first part consists of 5 questions which evaluate the worst pain level being experienced in the last 14 days, lying on the affected side, and level of pain during reaching up, reaching behind the neck, and pushing activity. The second part evaluates the disability level by questioning the level of limitation experienced by the individual during personal care, dressing and carrying activities. The total score range in the scale ranges from 0 to 130.
Change from baseline in pain and disability on the Shoulder Pain and Disability Index at week 3
Measuring the range of motion at shoulder joint
Shoulder active range of motion (flexion, abduction, internal and external rotation) will be measured with a universal goniometry.
Change from baseline in shoulder joint on the measuring the range of motion at shoulder joint at week 3
Full Information
NCT ID
NCT05469672
First Posted
July 18, 2022
Last Updated
September 27, 2022
Sponsor
Necmettin Erbakan University
1. Study Identification
Unique Protocol Identification Number
NCT05469672
Brief Title
The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
Official Title
The Effect of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2022 (Anticipated)
Primary Completion Date
September 25, 2022 (Anticipated)
Study Completion Date
October 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan 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
In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis
Detailed Description
This study will be designed as a randomized, prospective, single-blind clinical trial with a 3-week follow-up. A total of 50 patients who applied to our hospital with the complaint of shoulder pain will be evaluated for inclusion in the study. Patients will be randomized into two groups as high-intensity laser (HILT) + stretching exercise group and low-level laser (LLLT) + stretching exercise group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Disorder, Low Level Laser Therapy
Keywords
Adhesive capsulitis Pain, High-intensity laser therapy, Low-level laser therapy, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low-level laser therapy
Arm Type
Active Comparator
Arm Description
LLLT will be performed 3 times a week for a period of 3 weeks
Arm Title
high-intensity laser therapy
Arm Type
Active Comparator
Arm Description
HILT will be performed 3 times a week for a period of 3 weeks
Intervention Type
Other
Intervention Name(s)
Low-level laser therapy
Intervention Description
For LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period.
Intervention Type
Other
Intervention Name(s)
High-intensity laser therapy
Intervention Description
HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3
Description
This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Time Frame
Baseline-Week 3
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index
Description
The severity of pain and limitation experienced by individuals during certain activities will be evaluated with the Shoulder Pain and Disability Index (SPADI). SPADI is an evaluation method filled by the individual, lasting approximately 5-10 minutes, which questions the state of pain and disability in the shoulder. [11] SPADI consists of 2 sections and 13 sub-headings, namely pain and disability. The first part consists of 5 questions which evaluate the worst pain level being experienced in the last 14 days, lying on the affected side, and level of pain during reaching up, reaching behind the neck, and pushing activity. The second part evaluates the disability level by questioning the level of limitation experienced by the individual during personal care, dressing and carrying activities. The total score range in the scale ranges from 0 to 130.
Change from baseline in pain and disability on the Shoulder Pain and Disability Index at week 3
Time Frame
Baseline and week 3
Title
Measuring the range of motion at shoulder joint
Description
Shoulder active range of motion (flexion, abduction, internal and external rotation) will be measured with a universal goniometry.
Change from baseline in shoulder joint on the measuring the range of motion at shoulder joint at week 3
Time Frame
Baseline and week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged between 25-65 years
patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
patients with severe pain and shoulder limitation for at least 3 months
patients who are literate and able to understand verbal instructions in our language.
Exclusion Criteria:
Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
History of bilateral simultaneous adhesive capsulitis
Recent history of lung, breast, or bypass surgery/radiotherapy
History of corticosteroid injection to the same shoulder in the last 1 year
History of cervical radiculopathy/brachial plexus lesion
Neuromuscular disease history
History of physical therapy program for the same shoulder in the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BANU ORDAHAN
Phone
5058741256
Email
banuordahan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BANU ORDAHAN
Organizational Affiliation
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
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