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Completed

NCT Number: NCT03929276

Laser Therapy in Adhesive Capsulitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Shame laser & exercises

Device

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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