Effects of Sleeper Stretch and Mobilizations With Movement in Patients With Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

Effects of Sleeper Stretch and Mobilization With Movement in Patients With Adhesive Capsulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649410
• Other study ID #: REC -01394 Kiran Azam Khan
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 10, 2023

Study information

• Verified date: October 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Other:
• mobilization with movement and conventional therapy
Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation
• 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.

Locations

Country	Name	City	State
Pakistan	The Physiotherapy clinic Saidpur Road	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPRS (Numeric Pain Rating Scale)	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.	four weeks
Primary	Goniometer	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	four weeks
Primary	SPADI (Shoulder Pain and Disability Index)	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	four weeks
Primary	Scapulohumeral Rhythm	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.	four weeks