- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649410
Effects of Sleeper Stretch and Mobilizations With Movement in Patients With Adhesive Capsulitis
October 11, 2023 updated by: Riphah International University
Effects of Sleeper Stretch and Mobilization With Movement in Patients With Adhesive Capsulitis
Adhesive capsulitis is a condition characterized by progressive declination range of motion at the glenohumeral joint due to tightness of capsule.
The joint capsule and its surrounding connective tissue becomes stiffed, inflamed and shortened which in return causes decrease in range of motion that progress to chronic pain and stiffness.
Adhesive capsulitis is a self-limiting disorder that resolves within 1-3 years.
Study Overview
Status
Completed
Conditions
Detailed Description
Idiopathic (primary) adhesive capsulitis occurs spontaneously without a specific precipitating event.
Primary adhesive capsulitis results from a chronic inflammatory response with fibro elastic proliferation, which may actually be an abnormal response from the immune system.
Secondary adhesive capsulitis occurs after a shoulder injury or surgery or may be associated with another condition such as diabetes, rotator cuff injury, cerebrovascular accident or cardiovascular disease, which may prolong recovery and limit outcomes The prevalence of adhesive capsulitis is estimated at 2% to 5% of the general population.
Frozen shoulder mainly affects individuals of 40-65 years of age with a female predominance.
Adhesive Capsulitis follows a capsular pattern where external rotation is greatly restricted followed by abduction and internal rotation.
Adhesive capsulitis is classically characterized by three stages.
The length of each stage is variable, but typically the first stage (freezing) lasts for 3 to 6 months, the second stage (frozen) from 3 to 18 months and the final stage (thawing) from 3 to 6 months Currently various techniques are used, such as the application of moist heat, strengthening exercises, stretching and manual exercises for the treatment of Adhesive Capsulitis .Manual therapy techniques such as high and low grade glenohumeral mobilizations ,Proprioceptive neuromuscular facilitation techniques, Muscle energy Techniques, Mobilization with movement, and Sleeper stretch all have been proved effective for the treatment of adhesive capsulitis through different researches.
Conservative treatment includes various exercises method and physical therapy modalities such as a heat therapy, transcutaneous electrical nerve stimulation (TENS), Ultrasound (US), Acupuncture and (Light Amplification by Stimulated Emission of Radiation) LASER
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- The Physiotherapy clinic Saidpur Road
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with Adhesive Capsulitis of stage 1 and 2.
- Patients with idiopathic adhesive capsulitis.
- Patients with unilateral involvement having painful stiff shoulder for 3 or more months without any shoulder trauma.
- Marked loss in active and passive Range of Motion (Abduction, external and internal rotation) minimum 50% compared to the unaffected side.
- 1.5cm asymmetry on bilateral comparison during lateral scapular slide test.
Exclusion Criteria:
- Patients with shoulder pain due to neurological abnormalities e.g. Hemiplegia.
- Patients with Rotator cuff injury or tear.
- Recent trauma to upper limb.
- Disorders of bones such as fractures, osteoporosis, glenohumeral arthritis.
- Cervical spondylosis or cervical radiculopathy.
- Any malignancy or tumor.
- Patients having any intra articular injection in the gleno-humeral joint during last three months.
- Patients with cardiovascular impairments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mobilization with movement and conventional therapy
Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation
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Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation
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Experimental: sleeper stretch along with conventional therapy
IT will be performed with the patient in side lying on the affected side to stabilize the scapula against the table and both the shoulder and elbow flexed to 90°.In this position, passive Internal Rotation is applied to the affected shoulder by the therapist or patients opposite hand.
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it will be performed with the patient in side lying on the affected side to stabilize the scapula against the table and both the shoulder and elbow flexed to 90°.In this position, passive Internal Rotation is applied to the affected shoulder by the therapist or patients opposite hand.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NPRS (Numeric Pain Rating Scale)
Time Frame: four weeks
|
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain.
The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable.
intraclass correlation coefficient = 0.74 for shoulder pain.
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four weeks
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Goniometer
Time Frame: four weeks
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Shoulder range of motion i.e.
Shoulder Flexion, Extension, Abduction, Adduction, Internal rotation, External rotation will be measured using goniometer, intraclass correlation coefficient for using goniometer for shoulder joint Range Of Motion ranges from 0.91 to 0.99
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four weeks
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SPADI (Shoulder Pain and Disability Index)
Time Frame: four weeks
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The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with Activities of Daily Livings requiring the use of the upper extremities.
The pain subscale has 5-items and the Disability subscale has 8-items.
The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder.
The pain scale is summed up to a total of 50 while the disability scale sums up to 80.
The total SPADI score is expressed as a percentage.
A score of 0 indicates best 100 indicates worst.
A higher score shows more disability.
SPADI is reliable for subjects with Adhesive capsulitis, intraclass correlation coefficient for pain scale=0.989
and intraclass correlation coefficient for disability=0.990
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four weeks
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Scapulohumeral Rhythm
Time Frame: four weeks
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Scapular upward rotation will be measured using inclinometer placed at the spine of scapula.
Patient will be advised to perform shoulder abduction and measurements will be taken at 3 degrees i.e. 0 to 45degree, 0 to 90 degree, 0 to 120 degree.
3 measurements will be taken at each range and then their mean will be calculated.
Scapulohumeral rhythm will be measured by dividing humeral elevation with scapular upward rotation.
Scapulohumeral rhythm=humeral elevation/scapular upward rotation.
The intraclass correlation coefficient for measuring Scapulohumeral rhythm using inclinometer is > 0.892.
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four weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: maria Khalid, MSOMPT, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
July 10, 2023
Study Completion (Actual)
July 10, 2023
Study Registration Dates
First Submitted
December 6, 2022
First Submitted That Met QC Criteria
December 6, 2022
First Posted (Actual)
December 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC -01394 Kiran Azam Khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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