Adhesive Capsulitis of ShoulderNCT05810766
Mobilization With Movement Techniques of Shoulder Girdle in Patients With Chronic Adhesive Capsulitis
A study testing mobilization with movement and conventional physical therapy in people with Adhesive Capsulitis of Shoulder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Study will be a Randomized clinical trial to check Effects of mobilization with movement techniques of shoulder girdle on pain, range of motion and function in patients with chronic adhesive capsulitis so that we can devise a treatment protocol Total Thirty subjects will be included in this study .Out of total 15 will… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- mobilization with movement and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Aug 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients of Both gender
- Age 25-55 years
- Minimum 6 weeks chronicity of adhesive capsulitis
- Positive Apley's scratch test for adhesive capsulitis
- Idiopathic adhesive capsulitis
Who cannot join
- • Bilateral adhesive capsulitis
- Fractures of the Shoulder girdle
- Rheumatoid arthritis/ osteoarthritis
- Severe joint pain unrelieved by rest.
- Any bony or soft tissue systemic disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Suraiya majeed trust hospital
Faisalābad, Punjab Province, 54700
About this study
Official title: Effects of Mobilization With Movement Techniques of Shoulder Girdle on Pain, Range of Motion and Function in Patients With Chronic Adhesive Capsulitis
Study will be a Randomized clinical trial to check Effects of mobilization with movement techniques of shoulder girdle on pain, range of motion and function in patients with chronic adhesive capsulitis so that we can devise a treatment protocol Total Thirty subjects will be included in this study .Out of total 15 will be randomly allocated via lottery method in group 1 and 15 will be allocated in group 2. Group 1 will receive hot packs for 15 minutes for warming up, shoulder girdle mobilization with movement techniques along with other shoulder girdle joints mobilizations (sternoclavicular, acromioclavicular, cervicothoracic and scapulothoracic joints) and conventional physical therapy treatment while group 2 will receive only hot pack for 15 minutes and conventional physical therapy management. All patients will be treated for 12 sessions, two sessions per week for 6 weeks. Shoulder pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. Study setting will be suraiya majeed trust hospital. Assessment will be done at 0 weeks, 3 weeks, and 6 weeks. Data was analysed by using SPSS version 26.
Read the detailed description
The term "adhesive capsulitis describes the condition in which there is a restriction of active and passive ranges of the shoulder joint due to the thickening of the synovial capsule, pain, and stiffness. Our ability to interact with our surroundings is made possible by the shoulder's exceptional range of motion (ROM), which makes it a special anatomical structure. This study aims to determine the effects of mobilization with movement techniques of shoulder girdle on pain, range of motion, and function in patients with chronic adhesive capsulitis. Patients of both genders, idiopathic adhesive capsulitis, age group between 25-55 years, minimum six weeks chronicity of adhesive capsulitis, and patients with positive Apley's scratch test for adhesive capsulitis will be included, Patients having bilateral adhesive capsulitis, fractures of the Shoulder girdle, Rheumatoid arthritis/ osteoarthritis, severe joint pain unrelieved by rest and any bony or soft tissue systemic disease will be excluded In the previous literature there is study gap that provides a comprehensive treatment strategy for patients having chronic adhesive capsulitis The aim of this study is to apply MWM in patients having chronic adhesive capsulitis. A regional interdependence approach to shoulder dysfunction will be used in the treatment plan, taking into account the fact that glenohumeral function depends on scapular function, which in turn can also be affected by upper kinetic chain segments depending upon the patient's presentation, because of the close relation of surrounding joints (sternoclavicular, acromioclavicular, and scapulothoracic joints) with glenohumeral joint to gain complete effective shoulder ranges. That is why there is a great need for this study and in previous studies primarily acute patients were included therefore now it is necessary to draw attention to chronicity in adhesive capsulitis patients.
Mobilization with movement at the glenohumeral joint for improving flexion, abduction internal and external rotation. 3 sets of painless glides of 10 repetitions were given, with 1-minute rest between sets. and progression was added
Both groups received hot packs for 15 minutes for warming up and conventional physical therapy treatment
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- mobilization with movement, conventional physical therapy
- Keywords
- Adhesive Capsulitis, Manual therapy, Mobilization therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization with movementOther
MWM at glenohumeral joint and then we will add progression by adding glides at sternoclavicular and acromioclavicular joint.5 sets of painless glides of 10 repetitions will be given, with 3-minute rest between sets.
conventional physical therapyOther
Hot pack for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| mobilization with movement Group | Experimental | Week 1 \& 2: mobilization with movement at glenohumeral joint for improving flexion, abduction internal and external rotation. 3 sets of painless glides of 10 repetitions will be given, with 1 minute rest between sets.
* Week 2 \& 4:MWM at glenohumeral joint and then we will add progression by adding glides at sternoclavicular and acromioclavicular joint.5 sets of painless glides of 10 repetitions will be given, with 3-minute rest between sets.
* Week 3 \& 6:MWM at glenohumeral joint and glides at sternoclavicular, acromioclavicular along with glides at scapulothoracic. 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing the number of repetitions performed exercises for 3 weeks. Receives: Other: mobilization with movement |
| conventional physical therapy | Other | Hot pack for 15 minutes Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all."
Measured: up to 6 weeks
Goniometer
The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body
Measured: up to 6 weeks
Shoulder pain and disability index (SPADI)
The Shoulder Discomfort and Disability Index is a tool that may be used to determine the level of pain in people with adhesive capsulitis (SPADI). It was created to assess current shoulder discomfort and impairment in outpatients.(9) The Shoulder Pain and Disability Index (SPADI), a patient-completed questionnaire of 13 items, measures the severity of pain and the degree to which daily activities involving the use of the upper extremities are made more difficult. There are 5 items on the pain subscale and 8 on the disability subscale.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start15 Mar 2023
- Primary completion5 Aug 2023
- Study completion15 Aug 2023
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- khadija Musarat, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810766
- Sponsor's protocol ID
- REC/RCR & AHS/23/0115
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2023
- Last updated
- 18 Sep 2023
- 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 19468904Ramirez J. Adhesive Capsulitis: Diagnosis and Management. Am Fam Physician. 2019 Mar 1;99(5):297-300.
PubMed 30811157Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.
PubMed 33185587Patel R, Urits I, Wolf J, Murthy A, Cornett EM, Jones MR, Ngo AL, Manchikanti L, Kaye AD, Viswanath O. A Comprehensive Update of Adhesive Capsulitis and Minimally Invasive Treatment Options. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):91-107. doi: 10.64719/pb.4384.
PubMed 33633420Georgiannos D, Markopoulos G, Devetzi E, Bisbinas I. Adhesive Capsulitis of the Shoulder. Is there Consensus Regarding the Treatment? A Comprehensive Review. Open Orthop J. 2017 Feb 28;11:65-76. doi: 10.2174/1874325001711010065. eCollection 2017.
PubMed 28400876Doner G, Guven Z, Atalay A, Celiker R. Evalution of Mulligan's technique for adhesive capsulitis of the shoulder. J Rehabil Med. 2013 Jan;45(1):87-91. doi: 10.2340/16501977-1064.
PubMed 23037929Ali SA, Khan M. Comparison for efficacy of general exercises with and without mobilization therapy for the management of adhesive capsulitis of shoulder - An interventional study. Pak J Med Sci. 2015 Nov-Dec;31(6):1372-6. doi: 10.12669/pjms.316.7909.
PubMed 26870099
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobilization With Movement Techniques of Shoulder Girdle on Pain, Range of Motion and Function in Patients With Chronic Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05810766
- Acronym / sponsor ID
- REC/RCR & AHS/23/0115
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- Adhesive Capsulitis, Manual therapy, Mobilization therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 12 Apr 2023 (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.
Study will be a Randomized clinical trial to check Effects of mobilization with movement techniques of shoulder girdle on pain, range of motion and function in patients with chronic adhesive capsulitis so that we can devise a treatment protocol Total Thirty subjects will be included in this study .Out of total 15 will be randomly allocated via lottery method in group 1 and 15 will be allocated in group 2. Group 1 will receive hot packs for 15 minutes for warming up, shoulder girdle mobilization with movement techniques along with other shoulder girdle joints mobilizations (sternoclavicular, acromioclavicular, cervicothoracic and scapulothoracic joints) and conventional physical therapy treatment while group 2 will receive only hot pack for 15 minutes and conventional physical therapy management. All patients will be treated for 12 sessions, two sessions per week for 6 weeks. Shoulder pain and disability index consist of two parts, part one which assesses pain severity and part two which assesses functional disability. Study setting will be suraiya majeed trust hospital. Assessment will be done at 0 weeks, 3 weeks, and 6 weeks. Data was analysed by using SPSS version 26.
Detailed description
The term "adhesive capsulitis describes the condition in which there is a restriction of active and passive ranges of the shoulder joint due to the thickening of the synovial capsule, pain, and stiffness. Our ability to interact with our surroundings is made possible by the shoulder's exceptional range of motion (ROM), which makes it a special anatomical structure. This study aims to determine the effects of mobilization with movement techniques of shoulder girdle on pain, range of motion, and function in patients with chronic adhesive capsulitis. Patients of both genders, idiopathic adhesive capsulitis, age group between 25-55 years, minimum six weeks chronicity of adhesive capsulitis, and patients with positive Apley's scratch test for adhesive capsulitis will be included, Patients having bilateral adhesive capsulitis, fractures of the Shoulder girdle, Rheumatoid arthritis/ osteoarthritis, severe joint pain unrelieved by rest and any bony or soft tissue systemic disease will be excluded In the previous literature there is study gap that provides a comprehensive treatment strategy for patients having chronic adhesive capsulitis The aim of this study is to apply MWM in patients having chronic adhesive capsulitis. A regional interdependence approach to shoulder dysfunction will be used in the treatment plan, taking into account the fact that glenohumeral function depends on scapular function, which in turn can also be affected by upper kinetic chain segments depending upon the patient's presentation, because of the close relation of surrounding joints (sternoclavicular, acromioclavicular, and scapulothoracic joints) with glenohumeral joint to gain complete effective shoulder ranges. That is why there is a great need for this study and in previous studies primarily acute patients were included therefore now it is necessary to draw attention to chronicity in adhesive capsulitis patients.
Mobilization with movement at the glenohumeral joint for improving flexion, abduction internal and external rotation. 3 sets of painless glides of 10 repetitions were given, with 1-minute rest between sets. and progression was added
Both groups received hot packs for 15 minutes for warming up and conventional physical therapy treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobilization with movement Group | Experimental | Other: mobilization with movementWeek 1 \& 2: mobilization with movement at glenohumeral joint for improving flexion, abduction internal and external rotation. 3 sets of painless glides of 10 repetitions will be given, with 1 minute rest between sets. * Week 2 \& 4:MWM at glenohumeral joint and then we will add progression by adding glides at sternoclavicular and acromioclavicular joint.5 sets of painless glides of 10 repetitions will be given, with 3-minute rest between sets. * Week 3 \& 6:MWM at glenohumeral joint and glides at sternoclavicular, acromioclavicular along with glides at scapulothoracic. 5 sets of painless glides for 10 repetitions were given. Progression can be introduced by increasing the number of repetitions performed exercises for 3 weeks. |
| conventional physical therapy | Other | Other: conventional physical therapyHot pack for 15 minutes |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients of Both gender
Key exclusion criteria (5 listed)
- • Bilateral adhesive capsulitis
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 |
|---|---|---|
| mobilization with movementMWM at glenohumeral joint and then we will add progression by adding glides at sternoclavicular and acromioclavicular joint.5 sets of painless glides of 10 repetitions will be given, with 3-minute rest between sets. | Other | mobilization with movement Group |
| conventional physical therapyHot pack for 15 minutes | Other | conventional physical therapy |
Primary outcome
Numeric pain rating scale
Time frame: up to 6 weeks
Patients are asked to circle the number on a Numerical Rating Scale (NRS) that best describes their level of discomfort between 0 and 10, 0 and 20, or 0 and 100. The lower limit often denotes "the least amount of suffering ," whereas zero typically denotes "no pain at all."
Goniometer
Time frame: up to 6 weeks
The most popular and reliable approach for determining shoulder range of motion (ROM) is by utilizing a goniometer. A goniometer is a straightforward instrument that has two arms joined at a hinge. The goniometer's second arm would be used to measure the joint angle while the physiotherapist placed one arm of the patient against the patient's body
Shoulder pain and disability index (SPADI)
Time frame: up to 6 weeks
The Shoulder Discomfort and Disability Index is a tool that may be used to determine the level of pain in people with adhesive capsulitis (SPADI). It was created to assess current shoulder discomfort and impairment in outpatients.(9) The Shoulder Pain and Disability Index (SPADI), a patient-completed questionnaire of 13 items, measures the severity of pain and the degree to which daily activities involving the use of the upper extremities are made more difficult. There are 5 items on the pain subscale and 8 on the disability subscale.
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 18 Sep 2023.
- 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 30811157Ramirez J. Adhesive Capsulitis: Diagnosis and Management. Am Fam Physician. 2019 Mar 1;99(5):297-300.
- Background: PubMed 33185587Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.
- Background: PubMed 33633420Patel R, Urits I, Wolf J, Murthy A, Cornett EM, Jones MR, Ngo AL, Manchikanti L, Kaye AD, Viswanath O. A Comprehensive Update of Adhesive Capsulitis and Minimally Invasive Treatment Options. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):91-107. doi: 10.64719/pb.4384.
- Background: PubMed 28400876Georgiannos D, Markopoulos G, Devetzi E, Bisbinas I. Adhesive Capsulitis of the Shoulder. Is there Consensus Regarding the Treatment? A Comprehensive Review. Open Orthop J. 2017 Feb 28;11:65-76. doi: 10.2174/1874325001711010065. eCollection 2017.
- Background: PubMed 23037929Doner G, Guven Z, Atalay A, Celiker R. Evalution of Mulligan's technique for adhesive capsulitis of the shoulder. J Rehabil Med. 2013 Jan;45(1):87-91. doi: 10.2340/16501977-1064.
- Background: PubMed 26870099Ali SA, Khan M. Comparison for efficacy of general exercises with and without mobilization therapy for the management of adhesive capsulitis of shoulder - An interventional study. Pak J Med Sci. 2015 Nov-Dec;31(6):1372-6. doi: 10.12669/pjms.316.7909.
- 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.
khadija Musarat, MS* 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 mobilization with movement and conventional physical therapy 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 5 inclusion and 5 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 18 Sep 2023. 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?
Numeric pain rating scale (time frame: up to 6 weeks). The study lists 3 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 NCT05810766, 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 18 Sep 2023.