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Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan's Mobilization with movement
Spencer's muscle energy technique
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

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both male and female
  • Age bracket is 30-70 years
  • Pain in the shoulder for at least three months
  • All active and passive shoulder movements restricted, with a reduction in external rotation of at least 50%.

Exclusion Criteria:

  • Patients with

    • Recent history of surgery on particular shoulder
    • Post-traumatic and rotator cuff rupture
    • Neurological deficits affecting shoulder function
    • Pain or disorders of cervical spine, elbow, wrist or hand
    • Tendon calcification
    • Rheumatoid arthritis
    • Osteoporosis
    • Malignancies
    • Pregnancy
    • Open wounds or skin infections
    • Recent steroid injection
    • Previous manipulation under anesthesia of affected shoulder.

Sites / Locations

  • Tehsil headquarter hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A-Combined Group

Group B-Mulligan Group

Group C-Spencer Group

Group D-Conventional Group

Arm Description

Participants in this group will receive both Mulligan's mobilization with movement and Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.

Participants in this group will receive Mulligan's mobilization with movement along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.

Participants in this group will receive Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.

Participants in this group will receive conventional therapy alone in hospital with home exercise plan. 3 sessions per week will be given for 4 weeks.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for measurement of pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. It will be used at baseline, after first session and then every week up to 6th week.
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 Activity of daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. It will be used at baseline, every week up to 4th week and then after 2 week follow up on 6th week
Range of Motion
Ranges of motions of all shoulder movements will be measured. These include Flexion, Abduction, Eternal and Internal Rotation. It will be measured at baseline, after first session, every week up to 4th week and then after 2 week follow up on 6th week.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2022
Last Updated
September 5, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05450068
Brief Title
Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients
Official Title
Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
August 30, 2022 (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
This study will be a randomized control trial conducted on 44 patients diagnosed as adhesive capsulitis in headquarter hospital Gujar khan. Subjects will be divided equally into 4 groups (n=11 in each group) that are Group A, B, C and D by sealed envelope method. Pre-intervention assessment will be done by using data collection tools and then intervention will be applied. Group A will receive mobilization with movement (MWM) technique along with Spencer's muscle energy technique (MET) with conventional therapy. Group B will receive MWM along with conventional therapy. Group C will receive Spencer's MET along with conventional therapy. Group D will receive conventional therapy alone. All subjects will be given a home exercise plan. Assessment will be done after 1st session, 1st week, 2nd week, 3rd week and finally after 2 weeks on follow up using data collection tool. Data collection tools are semi-structured questionnaire (informed consent, demographic details, goniometric measurements), Visual analogue scale (VAS), shoulder pain and disability index (SPADI) and universal goniometer.
Detailed Description
One of the numerous disorders that causes pain and increase resistance to the active and passive movements of shoulder is the adhesive capsulitis. The pathology of the shoulder can be the extrinsic or intrinsic that induces pain and stiffness that is why the treatment should be according to the actual cause of pathology. Another term which is used for these pathology is 'Frozen Shoulder' which is used by the Codman for the first time in history. Adhesive capsulitis does not represent a single pathology rather it is applicable to most of the conditions that causes myospasm most specifically adhesion that forms in the bursa or joint capsule and rotators of the shoulder. Most specifically the term adhesive capsulitis is actually a pathology that includes the capsule's inflammation which results in thickness and fibrosis and consequently adherence to the shoulder as well as the neck of humerus. About 2%-5% of the global population is affected by the adhesive Capsulitis that's why it is considered as a common condition. Frozen shoulder the alternative term for adhesive capsulitis affect the 2% of the total world population because of the absent of most accurate criteria for diagnosis and sometime due to the over diagnosis. It is uncommon in people under the age of 40, peak prevalence is in people elder than 40 and younger than 60 and is uncommon in people above 70years except for secondary cause and in the manual workers as according to a cumulative incidence of 2.4 persons per 1000 in a year. Economically the impact of adhesive Capsulitis is underscored i-e 8.2% for men and 10.1% for women for adults in working age. It is more prevalent in women as compared to the men. It cannot develop in the same shoulder after the first time but in 20% of people it is seen to develop in the opposite Shoulder.14% of patients have seen to develop in both shoulders at one time, and 80% are those who develop this condition on opposite side within the next five years. Frozen shoulder is mostly common in patients suffering from diabetes mellitus. 71.5% of the people are estimated to have the diabetes and frozen shoulder at the same time half of them are previously diagnosed with type I or type II diabetes mellitus and remaining have high glucose tolerance test or increased fasting glucose level.The suspected risk of having frozen shoulder have increased a 10% to 20% in people who are diabetic, having 4% point prevalence, and 2-4 times on greater risk as compared to normal population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Study is single-blinded as the participants are unaware of the treatment given to them.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A-Combined Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive both Mulligan's mobilization with movement and Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.
Arm Title
Group B-Mulligan Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive Mulligan's mobilization with movement along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.
Arm Title
Group C-Spencer Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.
Arm Title
Group D-Conventional Group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive conventional therapy alone in hospital with home exercise plan. 3 sessions per week will be given for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Mulligan's Mobilization with movement
Intervention Description
The Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets.
Intervention Type
Other
Intervention Name(s)
Spencer's muscle energy technique
Intervention Description
Muscle energy technique that is composed of 7 stages repeated on after the other will be performed. Each movement will be repeated 10 times with 1 minute rest between each set.
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
Electrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises)
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales used for measurement of pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. It will be used at baseline, after first session and then every week up to 6th week.
Time Frame
6th week.
Title
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 Activity of daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. It will be used at baseline, every week up to 4th week and then after 2 week follow up on 6th week
Time Frame
6th week
Title
Range of Motion
Description
Ranges of motions of all shoulder movements will be measured. These include Flexion, Abduction, Eternal and Internal Rotation. It will be measured at baseline, after first session, every week up to 4th week and then after 2 week follow up on 6th week.
Time Frame
6th week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both male and female Age bracket is 30-70 years Pain in the shoulder for at least three months All active and passive shoulder movements restricted, with a reduction in external rotation of at least 50%. Exclusion Criteria: Patients with Recent history of surgery on particular shoulder Post-traumatic and rotator cuff rupture Neurological deficits affecting shoulder function Pain or disorders of cervical spine, elbow, wrist or hand Tendon calcification Rheumatoid arthritis Osteoporosis Malignancies Pregnancy Open wounds or skin infections Recent steroid injection Previous manipulation under anesthesia of affected shoulder.
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
Tehsil headquarter hospital
City
Gujar Khān
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients

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