Effects of Combining Mobilization With Movement and Spencer's Technique in Diabetic Adhesive Capsulitis Patients
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedSeptember 7, 2022
September 1, 2022
4 months
April 9, 2022
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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
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.
6th week.
Study Arms (4)
Group A-Combined Group
ACTIVE COMPARATORParticipants 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.
Group B-Mulligan Group
ACTIVE COMPARATORParticipants 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.
Group C-Spencer Group
ACTIVE COMPARATORParticipants 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.
Group D-Conventional Group
ACTIVE COMPARATORParticipants in this group will receive conventional therapy alone in hospital with home exercise plan. 3 sessions per week will be given for 4 weeks.
Interventions
The Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets.
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.
Electrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises)
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tehsil headquarter hospital
Gujar Khān, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Khalid, MSOMPT
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Study is single-blinded as the participants are unaware of the treatment given to them.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2022
First Posted
July 8, 2022
Study Start
April 15, 2022
Primary Completion
July 31, 2022
Study Completion
August 30, 2022
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share