Laser Therapy in Adhesive Capsulitis

NCT03929276 | Completed

• 1 other identifier: 19-KAEK-061
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of Shoulder

Keywords

adhesive capsulitis; high-intensity laser therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (3)

• Shoulder pain and disability index

  2 weeks

• Short Form Health Survey 36 (SF-36)

  2 weeks

• Range of motion of shoulder joint measurements

  2 weeks

Study Arms (3)

high-intensity laser therapy & exercises

EXPERIMENTAL

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

Device: high-intensity laser therapy & exercises; Other: exercise

Shame laser & exercises

PLACEBO COMPARATOR

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

Device: Shame laser & exercises; Other: exercise

control - exercises only group

ACTIVE COMPARATOR

exercise program

Other: exercise

Interventions

high-intensity laser therapy & exercises DEVICE

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.

high-intensity laser therapy & exercises

Shame laser & exercises DEVICE

Sham laser treatment (the same device to be used, 0 watts) will be given.

Shame laser & exercises

exercise OTHER

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.

Shame laser & exercises; control - exercises only group; high-intensity laser therapy & exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 19468904 BACKGROUND

• 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.

  PMID: 15373308 BACKGROUND

• 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.

  PMID: 32808147 DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Exercise Therapy; Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 26, 2019
• Study Start: April 22, 2019
• Primary Completion: September 22, 2019
• Study Completion: September 22, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)