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

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Other: Mulligan's Mobilization with movement; Other: Spencer's muscle energy technique; Other: Conventional Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Gujar Khān, Punjab, Pakistan
      • Tehsil Headquarter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group A-Combined Group; 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.	Other: Mulligan's Mobilization with movement; The Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets.; Other: Spencer's muscle energy technique; 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.; Other: Conventional Therapy; Electrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises)
ACTIVE_COMPARATOR: Group B-Mulligan Group; 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.	Other: Mulligan's Mobilization with movement; The Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets.
ACTIVE_COMPARATOR: Group C-Spencer Group; 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.	Other: Spencer's muscle energy technique; 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.
ACTIVE_COMPARATOR: Group D-Conventional Group; 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.	Other: Conventional Therapy; Electrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2022
• Primary Completion (ACTUAL): July 31, 2022
• Study Completion (ACTUAL): August 30, 2022

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (ACTUAL): July 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: REC/1012 Bushra

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No