Calcific Tendinitis of the ShoulderNCT02677103
Comparison of the Effect of Radial Shock Wave, Ultrasound-guided Needle Puncture, and Combination of Both in the Treatment of Calcific Tendinitis of the Shoulder
A study testing radial extracorporeal shock wave therapy, ultrasound-guided needle puncture and RSWT and USNP in people with Calcific Tendinitis of the Shoulder, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by inflammation around calcium hydroxyapatite crystal deposits, usually located in the supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals between 30 and 50 years of age, is painful in 50% of patients… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Calcific Tendinitis of the Shoulder
- What is being tested?
- radial extracorporeal shock wave therapy, ultrasound-guided needle puncture and RSWT and USNP
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Aug 2014
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20~75 y
- Subject with calcific tendinitis of the shoulder.
- Fulfill inclusion criteria and not meet exclusion criteria.
Who cannot join
- pregnancy, clotting disorders, anticoagulant or antiplatelet treatment, cardiac pacemaker, chronic inflammatory joint disease, infections or tumors of the shoulder, adhesive capsulitis, hyperalgia of the shoulder due to resorption of a calcific deposit, and calcification of type III as defined by Gartner or nodular or cystic type of calcification defined by Chiou.
Trial locations and contacts
1 site in 1 country.
About this study
Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by inflammation around calcium hydroxyapatite crystal deposits, usually located in the supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals between 30 and 50 years of age, is painful in 50% of patients and frequently leads to considerable restriction of motion.2,3 It goes through three distinct stages: a precalcific stage (metaplasia of matrix), calcific stage (calcification of matrix and resorption of calific deposits), and a postcalcific stage (reconstitution of matrix).
Classifications of calcific tendinitis have been proposed previously. Gartner proposed a classification based on plain films of the shoulder: type I deposits were sharply outlined and densely structured. Type III deposits had a cloudy outline and were transparent in structure. Type II deposits were features of both.4 Type III plaques have a tendency to resorb. Due to the progress of musculoskeletal ultrasound over the past decade, classification of the calcific tendinitis based on ultrasound findings was also proposed: arc-shaped (an echogenic arc with clear shadowing), fragmented or punctate (at least 2 separated echogenic spots or plaques with or without shadowing), nodular (an echogenic nodule without shadowing), and cystic (a bold echogenic wall with an anechoic area).5 Plaques that appear fragmented, nodular, or cystic on ultrasound are considered in the resorptive phase.
Read more
The treatment of patients with calcific tendinitis is typically conservative. The reported success rates vary between 30 and 85%.6 If the pain becomes chronic or intermittent after several months of conservative treatment, arthroscopic and open procedures are available to curette the calcium deposit, and additional subacromial decompression can be performed if necessary.7,8 As an alternative, minimally invasive extracorporeal shock wave therapy (ESWT) has been postulated to be an effective treatment option for treating calcific tendinopathy of the shoulder, before surgery.9-12 In recent years, radial shock wave has been developed. A radial shock wave is a low- to medium-energy shock wave that is pneumatically generated through acceleration of a projectile inside the handpiece of the treatment device and then transmitted radially from the tip of the applicator to the target zone. Radial shock wave showed a low pressure and a considerably longer rise time than extracorporeal shock wave. In radial shock wave therapy (RSWT), the focal point is not concentrated on the target zone, as occurred in ESWT, but on the tip of applicator. 13 Another new method of conservative treatment of calcific tendinopathy is ultrasound-guided fine-needle repeated puncture of the calcific plaque, as shown in previous study.14,15 The new method has the advantage of being easily operative, cheap, safe, and has a proven high success rate. Although percutaneous needle aspiration with a large size needle(≥ 18# needle) alleviates symptoms in up to 60% of patients and resolves the deposits in 40% to 74%,16,17 the larger size needle could result in tendon injury.
In clinical practice, combination of radial shock wave therapy and ultrasound-guided fine needle repeated puncture is frequently used and shows promising results, however, scientific report has been rarely published before.18 The purpose of this study is to compare the efficacy of RSWT, ultrasound-guided fine needle puncture (USNP), and combination of RSWT and USNP in the treatment of calcific tendinitis of shoulder.
Read the detailed description
A prospective, randomized, controlled trial will be conducted.Thirty patients in each group with calcific tendinitis of shoulder from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital.
- Conditions
- Calcific Tendinitis of the Shoulder
- Being tested
- radial extracorporeal shock wave therapy, ultrasound-guided needle puncture, RSWT and USNP
- Keywords
- Radial shock wave therapy,calcific tendinitis, ultrasound guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial extracorporeal shock wave therapyDevice
Also called RSWT
he RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder.
ultrasound-guided needle punctureProcedure or surgery
Also called USNP
After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed.
RSWT and USNPProcedure or surgery
each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs.
| Study group | Role | What they receive |
|---|---|---|
| RSWT group | Experimental | The RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder. RSWT will be performed once per week, and will be continued for 3 weeks. Receives: Device: radial extracorporeal shock wave therapy |
| USNP group | Experimental | All needle punctures will be guided by ultrasound (US). The puncture needle is a 3.8cm 22# needle attached on a 5ml syringe. Before puncture, the skin of the puncture site will be sterilized with better iodine, and the transducer will be covered with a sterilized plastic bag. After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed. The needle tract will be monitored by ultrasound to make sure the needle penetrated through the calcific plaque, but does not penetrate the rotator cuff. Receives: Procedure: ultrasound-guided needle puncture |
| RSWT plus USNP | Experimental | In this group, each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs Receives: Procedure: RSWT and USNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
VAS; horizontal lines of 100 mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right.
A VAS has been found to be reliable and sensitive tool for measuring pain, with test-retest reliability of >0.90. In previous studies of subjects treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.
Measured: 1.5 month, 3 months after the treatment.
Secondary outcomes (4)
Active ROM and passive ROM
conventional goniometer in accordance with the guideline of the American Academy of the Orthopedic Surgeons19 and included abduction in the frontal plane, forward flexion, and internal rotation and external rotation with the arm in 0 degrees of abduction
Measured: .5 month, 3 months after the treatment.
General health status: 36-Item Shot-Form Health Survey (SF-36)
The SF-36, the psychometric properties of which have been established for the Chinese language, is a generic measure of quality of life comprising 8 subscales for physical functioning, social functioning, role limitations (physical problems), role limitations (emotional problems), mental health, vitality, pain, and general health perception. Each subscale generates a score from 0 to 100, with higher score indicating better health. From these 8 health concepts, 2 summary scales, for physical health and mental health, can be computed.
Measured: 1.5 month, 3 months after the treatment.
Shoulder problems
Shoulder problems will be measured by means of Constant Score, which is a 100-point score system that included 15 points for pain, 20 points for activities of daily living, 40 points for shoulder motion, and 25 points for the muscle power of the affected arm.
Measured: .5 month, 3 months after the treatment.
Patients' satisfaction
Patients' satisfaction will be classified as very satisfactory, satisfactory, partially satisfactory, and unsatisfactory, scoring 1, 2, 3, and 4 points, respectively.
Measured: 1.5 month, 3 months after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific Tendinitis of the 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
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin-Fen Hsieh, M.D, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677103
- Sponsor's protocol ID
- 20120801R
- Status last verified
- Mar 2016
- First submitted
- 2 Sep 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Radial Shock Wave, Ultrasound-guided Needle Puncture, and Combination of Both in the Treatment of Calcific Tendinitis of the Shoulder
- ClinicalTrials.gov ID
- NCT02677103
- Acronym / sponsor ID
- 20120801R
- Conditions
- Calcific Tendinitis of the Shoulder
- Keywords
- Radial shock wave therapy,calcific tendinitis, ultrasound guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Feb 2016 (estimated)
- 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.
Calcific tendinitis of the shoulder is a common enthesopathy, and is characterized by inflammation around calcium hydroxyapatite crystal deposits, usually located in the supraspinatus tendon, near its insertion place.1 The disease mainly affects individuals between 30 and 50 years of age, is painful in 50% of patients and frequently leads to considerable restriction of motion.2,3 It goes through three distinct stages: a precalcific stage (metaplasia of matrix), calcific stage (calcification of matrix and resorption of calific deposits), and a postcalcific stage (reconstitution of matrix).
Classifications of calcific tendinitis have been proposed previously. Gartner proposed a classification based on plain films of the shoulder: type I deposits were sharply outlined and densely structured. Type III deposits had a cloudy outline and were transparent in structure. Type II deposits were features of both.4 Type III plaques have a tendency to resorb. Due to the progress of musculoskeletal ultrasound over the past decade, classification of the calcific tendinitis based on ultrasound findings was also proposed: arc-shaped (an echogenic arc with clear shadowing), fragmented or punctate (at least 2 separated echogenic spots or plaques with or without shadowing), nodular (an echogenic nodule without shadowing), and cystic (a bold echogenic wall with an anechoic area).5 Plaques that appear fragmented, nodular, or cystic on ultrasound are considered in the resorptive phase.
The treatment of patients with calcific tendinitis is typically conservative. The reported success rates vary between 30 and 85%.6 If the pain becomes chronic or intermittent after several months of conservative treatment, arthroscopic and open procedures are available to curette the calcium deposit, and additional subacromial decompression can be performed if necessary.7,8 As an alternative, minimally invasive extracorporeal shock wave therapy (ESWT) has been postulated to be an effective treatment option for treating calcific tendinopathy of the shoulder, before surgery.9-12 In recent years, radial shock wave has been developed. A radial shock wave is a low- to medium-energy shock wave that is pneumatically generated through acceleration of a projectile inside the handpiece of the treatment device and then transmitted radially from the tip of the applicator to the target zone. Radial shock wave showed a low pressure and a considerably longer rise time than extracorporeal shock wave. In radial shock wave therapy (RSWT), the focal point is not concentrated on the target zone, as occurred in ESWT, but on the tip of applicator. 13 Another new method of conservative treatment of calcific tendinopathy is ultrasound-guided fine-needle repeated puncture of the calcific plaque, as shown in previous study.14,15 The new method has the advantage of being easily operative, cheap, safe, and has a proven high success rate. Although percutaneous needle aspiration with a large size needle(≥ 18# needle) alleviates symptoms in up to 60% of patients and resolves the deposits in 40% to 74%,16,17 the larger size needle could result in tendon injury.
In clinical practice, combination of radial shock wave therapy and ultrasound-guided fine needle repeated puncture is frequently used and shows promising results, however, scientific report has been rarely published before.18 The purpose of this study is to compare the efficacy of RSWT, ultrasound-guided fine needle puncture (USNP), and combination of RSWT and USNP in the treatment of calcific tendinitis of shoulder.
Detailed description
A prospective, randomized, controlled trial will be conducted.Thirty patients in each group with calcific tendinitis of shoulder from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RSWT group | Experimental | Device: radial extracorporeal shock wave therapyThe RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder. RSWT will be performed once per week, and will be continued for 3 weeks. |
| USNP group | Experimental | Procedure: ultrasound-guided needle punctureAll needle punctures will be guided by ultrasound (US). The puncture needle is a 3.8cm 22# needle attached on a 5ml syringe. Before puncture, the skin of the puncture site will be sterilized with better iodine, and the transducer will be covered with a sterilized plastic bag. After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed. The needle tract will be monitored by ultrasound to make sure the needle penetrated through the calcific plaque, but does not penetrate the rotator cuff. |
| RSWT plus USNP | Experimental | Procedure: RSWT and USNPIn this group, each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20~75 y
- Subject with calcific tendinitis of the shoulder.
- Fulfill inclusion criteria and not meet exclusion criteria.
Key exclusion criteria (1 listed)
- pregnancy, clotting disorders, anticoagulant or antiplatelet treatment, cardiac pacemaker, chronic inflammatory joint disease, infections or tumors of the shoulder, adhesive capsulitis, hyperalgia of the shoulder due to resorption of a calcific deposit, and calcification of type III as defined by Gartner or nodular or cystic type of calcification defined by Chiou.
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 |
|---|---|---|
| radial extracorporeal shock wave therapyAlso: RSWThe RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder. | Device | RSWT group |
| ultrasound-guided needle punctureAlso: USNPAfter injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed. | Procedure or surgery | USNP group |
| RSWT and USNPeach subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs. | Procedure or surgery | RSWT plus USNP |
Primary outcome
Pain (VAS)
Time frame: 1.5 month, 3 months after the treatment.
VAS; horizontal lines of 100 mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right. A VAS has been found to be reliable and sensitive tool for measuring pain, with test-retest reliability of >0.90. In previous studies of subjects treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.
4 secondary outcomes
Active ROM and passive ROM
Time frame: .5 month, 3 months after the treatment.
General health status: 36-Item Shot-Form Health Survey (SF-36)
Time frame: 1.5 month, 3 months after the treatment.
Shoulder problems
Time frame: .5 month, 3 months after the treatment.
Patients' satisfaction
Time frame: 1.5 month, 3 months after the treatment.
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 25 Mar 2016.
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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.
Lin-Fen Hsieh, M.D principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radial extracorporeal shock wave therapy, ultrasound-guided needle puncture and RSWT and USNP in people with Calcific Tendinitis of the Shoulder, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 1 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 25 Mar 2016. 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 Taiwan. 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. 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?
Pain (VAS) (time frame: 1.5 month, 3 months after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2016.