Adhesive Capsulitis of ShoulderNCT03929276
Laser Therapy in Adhesive Capsulitis
A study testing high-intensity laser therapy & exercises and exercise in people with Adhesive Capsulitis of Shoulder, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- high-intensity laser therapy & exercises and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2019to 22 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High-intensity Laser Therapy in Patients With 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.
Read the 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.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- high-intensity laser therapy & exercises, Shame laser & exercises, exercise
- Keywords
- adhesive capsulitis, high-intensity laser therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity laser therapy & exercisesDevice
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 & exercisesDevice
Sham laser treatment (the same device to be used, 0 watts) will be given.
exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity laser therapy & exercises | Experimental | High-intensity laser therapy application with iLux Laser device + exercise program Receives: 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 Receives: Device: Shame laser & exercises; Other: exercise |
| control - exercises only group | Active comparator | exercise program Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (3)
Shoulder pain and disability index
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.
Measured: 2 weeks
Short Form Health Survey 36 (SF-36)
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).
Measured: 2 weeks
Range of motion of shoulder joint measurements
shoulder flexion, abduction, external rotation and internal rotation
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start22 Apr 2019
- Primary completion22 Sep 2019
- Study completion22 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929276
- Sponsor's protocol ID
- 19-KAEK-061
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19468904Dudkiewicz 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.
PubMed 15373308Atan 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.
PubMed 32808147
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT03929276
- Acronym / sponsor ID
- 19-KAEK-061
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- adhesive capsulitis, high-intensity laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 22 Sep 2019 (actual)
- Study completion
- 22 Sep 2019 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-intensity laser therapy & exercises | Experimental | Device: high-intensity laser therapy & exercises, Other: exerciseHigh-intensity laser therapy application with iLux Laser device + exercise program |
| Shame laser & exercises | Placebo comparator | Device: Shame laser & exercises, Other: exerciseSham high-intensity laser therapy application with iLux Laser device + exercise program |
| control - exercises only group | Active comparator | Other: exerciseexercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensity laser therapy & exercisesA 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. | Device | high-intensity laser therapy & exercises |
| Shame laser & exercisesSham laser treatment (the same device to be used, 0 watts) will be given. | Device | Shame laser & exercises |
| exerciseTherapeutic 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. | Other | Shame laser & exercises, control - exercises only group, high-intensity laser therapy & exercises |
Primary outcome
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.
3 secondary outcomes
Shoulder pain and disability index
Time frame: 2 weeks
Short Form Health Survey 36 (SF-36)
Time frame: 2 weeks
Range of motion of shoulder joint measurements
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 19468904Manske 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.
- Background: PubMed 15373308Dudkiewicz 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.
- Derived from this study: PubMed 32808147Atan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity laser therapy & exercises and exercise in people with Adhesive Capsulitis of Shoulder, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale for pain (VAS- pain) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03929276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.