Clinical trial NCT05450068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 6th week.
measure: Shoulder Pain and Disability Index
timeFrame: 6th week
measure: Range of Motion
timeFrame: 6th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Gujar Khān
country: Pakistan
facility: Tehsil headquarter hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria Khalid, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References: