The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Low Level Laser Therapy; Pain Disorder
• Interventions: Other: Low-level laser therapy; Other: High-intensity laser therapy

• Registration Number: NCT05469672
• Lead Sponsor: Necmettin Erbakan University

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.

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Status Verified: 2022-09
• Study Start: 2022-09-25
• Primary Completion: 2022-09-25
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Study Completion: 2022-10-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. patients aged between 25-65 years
2. 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
3. patients with severe pain and shoulder limitation for at least 3 months
4. patients who are literate and able to understand verbal instructions in our language.

Exclusion Criteria

1. Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
2. History of bilateral simultaneous adhesive capsulitis
3. Recent history of lung, breast, or bypass surgery/radiotherapy
4. History of corticosteroid injection to the same shoulder in the last 1 year
5. History of cervical radiculopathy/brachial plexus lesion
6. Neuromuscular disease history
7. History of physical therapy program for the same shoulder in the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-level laser therapy	High-intensity laser therapy	LLLT will be performed 3 times a week for a period of 3 weeks
high-intensity laser therapy	High-intensity laser therapy	HILT will be performed 3 times a week for a period of 3 weeks
low-level laser therapy	Low-level laser therapy	LLLT will be performed 3 times a week for a period of 3 weeks
high-intensity laser therapy	Low-level laser therapy	HILT will be performed 3 times a week for a period of 3 weeks

Primary Outcome Measures

Name	Time	Method
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	Baseline-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

Name	Time	Method
Measuring the range of motion at shoulder joint	Baseline and week 3	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
Shoulder Pain and Disability Index	Baseline and week 3	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