Adhesive Capsulitis of ShoulderNCT04578366
Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis
A study testing Extracorporeal Shockwave Therapy and Conventional Treatment in people with Adhesive Capsulitis of Shoulder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Extracorporeal Shockwave Therapy and Conventional Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2019to 28 Jun 2020
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months.
- ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
- No treatment other than analgesics with unresponsive ROM restriction for the past 2months.
- Unwilling or waiting and did not undergo joint injection.
Who cannot join
- bilateral shoulder involvement
- History of previous surgery on the shoulder
- Shoulder fracture
- Cancer
- Glenohumeral or Acromioclavicular arthritis
- Inflammatory disorders
Show all 13Show fewer
- Bleeding disorders
- Diabetes mellitus
- Presence of severe osteoporosis
- Pulmonary diseases
- Any neuromuscular disorders
- Pregnancy
- Implanted pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis
Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.
Read the detailed description
This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.
One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Extracorporeal Shockwave Therapy, Conventional Treatment
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDevice
Also called Experimental Group
ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
Conventional TreatmentOther
hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
| Study group | Role | What they receive |
|---|---|---|
| Shockwavetherapy Group/Experimental group | Experimental | ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder Receives: Device: Extracorporeal Shockwave Therapy |
| Conventional Group | Active comparator | Conventional therapy hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Shoulder Score (CSS)
The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side)
>30 Poor 21-30 Fair 11-20 Good <11 Excellent
Measured: 8 months
Range of motion
Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.
Measured: 8 months
Secondary outcomes (1)
NPRS-numeric pain rating scale
This scale ranges 0-10, 10 means severe pain while 0 means no pain
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2019
- Primary completion20 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, M.Phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578366
- Sponsor's protocol ID
- RE-MS-OMPT/Spring19/032 Adnan
- Status last verified
- Oct 2020
- First submitted
- 25 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calis M, Demir H, Ulker S, Kirnap M, Duygulu F, Calis HT. Is intraarticular sodium hyaluronate injection an alternative treatment in patients with adhesive capsulitis? Rheumatol Int. 2006 Apr;26(6):536-40. doi: 10.1007/s00296-005-0022-2. Epub 2005 Aug 10.
PubMed 16091920Hussein AZ, Donatelli RA. The efficacy of radial extracorporeal shockwave therapy in shoulder adhesive capsulitis: a prospective, randomised, double-blind, placebo-controlled, clinical study. European Journal of Physiotherapy. 2015;18(1):63-76.
Massoud SN, Pearse EO, Levy O, Copeland SA. Operative management of the frozen shoulder in patients with diabetes. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):609-13. doi: 10.1067/mse.2002.127301.
PubMed 12469088Wohlgethan JR. Frozen shoulder in hyperthyroidism. Arthritis Rheum. 1987 Aug;30(8):936-9. doi: 10.1002/art.1780300815.
PubMed 3498494Lee S, Lee S, Jeong M, Oh H, Lee K. The effects of extracorporeal shock wave therapy on pain and range of motion in patients with adhesive capsulitis. J Phys Ther Sci. 2017 Nov;29(11):1907-1909. doi: 10.1589/jpts.29.1907. Epub 2017 Nov 24.
PubMed 29200621Santoboni F, Balducci S, D'Errico V, Haxhi J, Vetrano M, Piccinini G, Ferretti A, Pugliese G, Vulpiani MC. Extracorporeal Shockwave Therapy Improves Functional Outcomes of Adhesive Capsulitis of the Shoulder in Patients With Diabetes. Diabetes Care. 2017 Feb;40(2):e12-e13. doi: 10.2337/dc16-2063. Epub 2016 Nov 29. No abstract available.
PubMed 27899492Chen CY, Hu CC, Weng PW, Huang YM, Chiang CJ, Chen CH, Tsuang YH, Yang RS, Sun JS, Cheng CK. Extracorporeal shockwave therapy improves short-term functional outcomes of shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2014 Dec;23(12):1843-1851. doi: 10.1016/j.jse.2014.08.010.
PubMed 25441567
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04578366
- Acronym / sponsor ID
- RE-MS-OMPT/Spring19/032 Adnan
- Conditions
- Adhesive Capsulitis of Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 8 Oct 2020 (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 refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.
Detailed description
This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.
One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwavetherapy Group/Experimental group | Experimental | Device: Extracorporeal Shockwave TherapyESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder |
| Conventional Group | Active comparator | Other: Conventional TreatmentConventional therapy hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months.
- ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
- No treatment other than analgesics with unresponsive ROM restriction for the past 2months.
- Unwilling or waiting and did not undergo joint injection.
Key exclusion criteria (13 listed)
- bilateral shoulder involvement
- History of previous surgery on the shoulder
- Shoulder fracture
- Cancer
- Glenohumeral or Acromioclavicular arthritis
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyAlso: Experimental GroupESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder | Device | Shockwavetherapy Group/Experimental group |
| Conventional Treatmenthot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder | Other | Conventional Group |
Primary outcome
Constant Shoulder Score (CSS)
Time frame: 8 months
The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side) >30 Poor 21-30 Fair 11-20 Good <11 Excellent
Range of motion
Time frame: 8 months
Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.
1 secondary outcome
NPRS-numeric pain rating scale
Time frame: 8 months
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 8 Oct 2020.
- Background: PubMed 16091920Calis M, Demir H, Ulker S, Kirnap M, Duygulu F, Calis HT. Is intraarticular sodium hyaluronate injection an alternative treatment in patients with adhesive capsulitis? Rheumatol Int. 2006 Apr;26(6):536-40. doi: 10.1007/s00296-005-0022-2. Epub 2005 Aug 10.
- BackgroundHussein AZ, Donatelli RA. The efficacy of radial extracorporeal shockwave therapy in shoulder adhesive capsulitis: a prospective, randomised, double-blind, placebo-controlled, clinical study. European Journal of Physiotherapy. 2015;18(1):63-76.
- Background: PubMed 12469088Massoud SN, Pearse EO, Levy O, Copeland SA. Operative management of the frozen shoulder in patients with diabetes. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):609-13. doi: 10.1067/mse.2002.127301.
- Background: PubMed 3498494Wohlgethan JR. Frozen shoulder in hyperthyroidism. Arthritis Rheum. 1987 Aug;30(8):936-9. doi: 10.1002/art.1780300815.
- Background: PubMed 29200621Lee S, Lee S, Jeong M, Oh H, Lee K. The effects of extracorporeal shock wave therapy on pain and range of motion in patients with adhesive capsulitis. J Phys Ther Sci. 2017 Nov;29(11):1907-1909. doi: 10.1589/jpts.29.1907. Epub 2017 Nov 24.
- Background: PubMed 27899492Santoboni F, Balducci S, D'Errico V, Haxhi J, Vetrano M, Piccinini G, Ferretti A, Pugliese G, Vulpiani MC. Extracorporeal Shockwave Therapy Improves Functional Outcomes of Adhesive Capsulitis of the Shoulder in Patients With Diabetes. Diabetes Care. 2017 Feb;40(2):e12-e13. doi: 10.2337/dc16-2063. Epub 2016 Nov 29. No abstract available.
- Background: PubMed 25441567Chen CY, Hu CC, Weng PW, Huang YM, Chiang CJ, Chen CH, Tsuang YH, Yang RS, Sun JS, Cheng CK. Extracorporeal shockwave therapy improves short-term functional outcomes of shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2014 Dec;23(12):1843-1851. doi: 10.1016/j.jse.2014.08.010.
- 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.
Maryam Shabbir, M.Phil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy and Conventional Treatment in people with Adhesive Capsulitis of Shoulder, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 13 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 8 Oct 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 Pakistan. 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?
Constant Shoulder Score (CSS) (time frame: 8 months). The study lists 2 primary outcomes in all. 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 NCT04578366, which also lists 7 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 8 Oct 2020.