search
Back to results

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

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
mobilization with movement and conventional therapy
sleeper stretch along with conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring pain, sleeper stretch, mobilization with movement, range of motion

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Physiotherapy clinic Saidpur Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

mobilization with movement and conventional therapy

sleeper stretch along with conventional therapy

Arm Description

Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation

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.

Outcomes

Primary Outcome Measures

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.
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
October 11, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05649410
Brief Title
Effects of Sleeper Stretch and Mobilizations With Movement in Patients With Adhesive Capsulitis
Official Title
Effects of Sleeper Stretch and Mobilization With Movement in Patients With Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
pain, sleeper stretch, mobilization with movement, range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mobilization with movement and conventional therapy
Arm Type
Experimental
Arm Description
Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation
Arm Title
sleeper stretch along with conventional therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
mobilization with movement and conventional therapy
Intervention Description
Mobilization with movement for Flexion, Abduction, Internal rotation, external rotation
Intervention Type
Other
Intervention Name(s)
sleeper stretch along with conventional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
NPRS (Numeric Pain Rating Scale)
Description
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.
Time Frame
four weeks
Title
Goniometer
Description
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
Time Frame
four weeks
Title
SPADI (Shoulder Pain and Disability Index)
Description
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
Time Frame
four weeks
Title
Scapulohumeral Rhythm
Description
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.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maria Khalid, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Physiotherapy clinic Saidpur Road
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs