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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06387537
Other study ID # FUI/CTR/2024/2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date July 15, 2024

Study information

Verified date April 2024
Source Foundation University Islamabad
Contact Mubeen Farooq, MS-MSKPT*
Phone +923499205017
Email mubeenkayani80@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 15, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional physical therapy
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.
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.

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary Pain Intensity Pain will be assessed using Visual Analog scale which is 0-100 item scale. 4 weeks
Secondary Shoulder Range of motion Range of motion will be assessed using universal goniometer. 4 weeks
Secondary Shoulder Disability Shoulder Disability will be assessed using shoulder pain and disability index. 4 weeks
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