Clinical trial NCT03929276: Laser Therapy in Adhesive Capsulitis
Official title: Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Keywords: adhesive capsulitis
high-intensity laser therapy
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Visual analogue scale for pain (VAS- pain)
timeFrame: 2 weeks
Secondary outcomes:
measure: Shoulder pain and disability index
timeFrame: 2 weeks
measure: Short Form Health Survey 36 (SF-36)
timeFrame: 2 weeks
measure: Range of motion of shoulder joint measurements
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Tuğba Atan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.