Adhesive CapsulitisNCT06387537
Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis
A study testing Conventional physical therapy and Scapular mobilization. in people with Adhesive Capsulitis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Conventional physical therapy and Scapular mobilization.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 15 Jul 2024
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease)
- 40-65 years of age both males and females.
- Chronic shoulder pain > 3 months.
Who cannot join
- Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
- Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
- Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 460000
Zara Khalid, DPT, MS-CPPT,PHD*, +923335415822, zara.khalid@fui.edu.pk
About this study
Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits.
Read the detailed description
Adhesive capsulitis is a common MSK condition with an insidious onset accompanied by stiffness and trouble sleeping on the affected side.This condition effects General population 2-5% globally, diabetics 10-20%. Women have a significantly higher incidence males 70% of cases are female.Adhesive capsulitis is a painful, gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.
The deficit in shoulder proprioception associated to pain and destruction to specific tissues including labrum, peri-capsular m/s ligaments \& joint capsule.Scapular position and movement perception both affected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis.
Scapulothoracic joint mobilization improve kinematic of shoulder including scapulohumeral rhythm. This mobilization changes the relative position of scapula and reduce stress on Gleno-humeral joint.There are still many unanswered questions in the domain of position and movement senses, particularly with regard to rehabilitation of shoulder proprioception in patients with adhesive capsulitis.
Hence the current study will investigate the effects of scapular mobilization on shoulder proprioception and pain in patients with adhesive capsulitis.
This study includes Subjects with nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease) ,40-65 years of age both males and females and chronic shoulder pain > 3 months.The selection of subjects will be using non-probability purposive sampling technique.Participants will be randomized using sealed envelope method and allocated to one of the 2 groups.
The data collection tools for pain is VAS, for ROM and PROPRIOCEPTION is Goniometer and for disability is SPADI.
The time duration for treatment protocol is total of 12 sessions, 3 sessions per week for 4 consecutive weeks for approximately 25-30 mins.
- Conditions
- Adhesive Capsulitis
- Being tested
- Conventional physical therapy, Scapular mobilization.
- Keywords
- Chronic pain, proprioception, scapular mobilization
- Medical subject headings
- Bursitis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyProcedure or surgery
Patients in this group will recieve hot pack, ROM exercises, strengthening exercises and Kaltenborn mobilizations. A total of 12 sessions, 3 sessions per week for 4 consecutive weeks. Sets and repetitions will be increased progressively.
Scapular mobilization.Procedure or surgery
Scapular Mobilizations: Glides- superior, inferior, distraction, upward and downward rotation (5 sets, 10 reps, 30 sec break in 1 session).Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Conventional Physical Therapy ) | Active comparator | Patients in this group will receive conventional physical therapy including Hot pack for 10 to 15 minutes, ROM exercises such as Internal \& external rotation, Extension in standing, Pulley for elevation in sitting or standing, Forward flexion in supine using own head, pendulum (1min clockwise, 1 min anti clock wise),these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, AAROM.
GH mobilization: kaltenborn low grade mobilization (grade I or II) for (1 minute), Then mobilization with movement 3 sets of 10 reps with 1 minute rest in between will be given.Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall. Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 weeks. Receives: Procedure: Conventional physical therapy |
| Group B (Conventional physical therapy and Scapular mobilization) | Experimental | Patients will receive scapular mobilization in addition to conventional physical therapy including Hot pack for 10 to 15 minutes , ROM exercises such as Internal \& external rotation, Extension in standing, Pulley for elevation in sitting or standing, Forward flexion in supine using own head, pendulum (1min clockwise, 1 min anti clock wise),these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, AAROM. GH mobilization: kaltenborn low grade mobilization (grade I or II) for (1 minute), Then mobilization with movement 3 sets of 10 reps with 1 minute rest in between will be given. Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.
Scapular Mobilizations Glides- superior, inferior, distraction, upward and downward rotation (5 sets, 10 reps, 30 sec break in 1 session).Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 consecutive weeks. Receives: Procedure: Conventional physical therapy; Procedure: Scapular mobilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Proprioception
Proprioception will be measured using the universal Goniometer which is 0 to 180 degree for half circle model or 0 to 360 degree for full circle models.
Measured: 4 weeks
Pain Intensity
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
Measured: 4 weeks
Secondary outcomes (2)
Shoulder Range of motion
Range of motion will be assessed using universal goniometer.
Measured: 4 weeks
Shoulder Disability
Shoulder Disability will be assessed using shoulder pain and disability index.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387537
- Sponsor's protocol ID
- FUI/CTR/2024/2
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06387537
- Acronym / sponsor ID
- FUI/CTR/2024/2
- Conditions
- Adhesive Capsulitis
- Keywords
- Chronic pain, proprioception, scapular mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 29 Apr 2024 (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 a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits.
Detailed description
Adhesive capsulitis is a common MSK condition with an insidious onset accompanied by stiffness and trouble sleeping on the affected side.This condition effects General population 2-5% globally, diabetics 10-20%. Women have a significantly higher incidence males 70% of cases are female.Adhesive capsulitis is a painful, gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.
The deficit in shoulder proprioception associated to pain and destruction to specific tissues including labrum, peri-capsular m/s ligaments \& joint capsule.Scapular position and movement perception both affected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis.
Scapulothoracic joint mobilization improve kinematic of shoulder including scapulohumeral rhythm. This mobilization changes the relative position of scapula and reduce stress on Gleno-humeral joint.There are still many unanswered questions in the domain of position and movement senses, particularly with regard to rehabilitation of shoulder proprioception in patients with adhesive capsulitis.
Hence the current study will investigate the effects of scapular mobilization on shoulder proprioception and pain in patients with adhesive capsulitis.
This study includes Subjects with nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease) ,40-65 years of age both males and females and chronic shoulder pain > 3 months.The selection of subjects will be using non-probability purposive sampling technique.Participants will be randomized using sealed envelope method and allocated to one of the 2 groups.
The data collection tools for pain is VAS, for ROM and PROPRIOCEPTION is Goniometer and for disability is SPADI.
The time duration for treatment protocol is total of 12 sessions, 3 sessions per week for 4 consecutive weeks for approximately 25-30 mins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Group A (Conventional Physical Therapy ) | Active comparator | Procedure: Conventional physical therapyPatients in this group will receive conventional physical therapy including Hot pack for 10 to 15 minutes, ROM exercises such as Internal \& external rotation, Extension in standing, Pulley for elevation in sitting or standing, Forward flexion in supine using own head, pendulum (1min clockwise, 1 min anti clock wise),these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, AAROM. GH mobilization: kaltenborn low grade mobilization (grade I or II) for (1 minute), Then mobilization with movement 3 sets of 10 reps with 1 minute rest in between will be given.Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall. Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 weeks. |
| Group B (Conventional physical therapy and Scapular mobilization) | Experimental | Procedure: Conventional physical therapy, Procedure: Scapular mobilization.Patients will receive scapular mobilization in addition to conventional physical therapy including Hot pack for 10 to 15 minutes , ROM exercises such as Internal \& external rotation, Extension in standing, Pulley for elevation in sitting or standing, Forward flexion in supine using own head, pendulum (1min clockwise, 1 min anti clock wise),these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, AAROM. GH mobilization: kaltenborn low grade mobilization (grade I or II) for (1 minute), Then mobilization with movement 3 sets of 10 reps with 1 minute rest in between will be given. Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall. Scapular Mobilizations Glides- superior, inferior, distraction, upward and downward rotation (5 sets, 10 reps, 30 sec break in 1 session).Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 consecutive weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with Nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease)
- 40-65 years of age both males and females.
- Chronic shoulder pain > 3 months.
Key exclusion criteria (3 listed)
- Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
- Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
- Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).
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 |
|---|---|---|
| Conventional physical therapyPatients in this group will recieve hot pack, ROM exercises, strengthening exercises and Kaltenborn mobilizations. A total of 12 sessions, 3 sessions per week for 4 consecutive weeks. Sets and repetitions will be increased progressively. | Procedure or surgery | Group A (Conventional Physical Therapy ), Group B (Conventional physical therapy and Scapular mobilization) |
| Scapular mobilization.Scapular Mobilizations: Glides- superior, inferior, distraction, upward and downward rotation (5 sets, 10 reps, 30 sec break in 1 session).Every session will be given for 30 minutes and a total of 12 sessions would be conducted over a period of 4 consecutive weeks. | Procedure or surgery | Group B (Conventional physical therapy and Scapular mobilization) |
Primary outcome
Shoulder Proprioception
Time frame: 4 weeks
Proprioception will be measured using the universal Goniometer which is 0 to 180 degree for half circle model or 0 to 360 degree for full circle models.
Pain Intensity
Time frame: 4 weeks
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
2 secondary outcomes
Shoulder Range of motion
Time frame: 4 weeks
Shoulder Disability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy and Scapular mobilization. in people with Adhesive Capsulitis, run by Foundation University Islamabad 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mubeen Farooq, MS-MSKPT* (+923499205017, mubeenkayani80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Proprioception (time frame: 4 weeks). 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?
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 29 Apr 2024.