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Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Muscle energy technique
Kaltonborn mobilizations
Sponsored by
Health Education Research Foundation (HERF)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring Adhesive Capsulitis,Mobilizations, muscle energy technique

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 20 and 60 years.
  • Duration of complaint for more than 3 months.
  • Gender: Both Male and Female.
  • Patients with idiopathic frozen shoulder
  • Patients having restriction in more than 2 ranges
  • Patients with diabetes

Exclusion Criteria:

  • Shoulder dislocation, fracture or labral tear.
  • Shoulder girdle motor control deficit associated with neurological disorder.
  • Any bony deformities acquired or congenital in glenohumeral joint.
  • Patients with language barrier.

Sites / Locations

  • Holy family hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Muscle energy technique

Kaltonborn mobilizations

Outcomes

Primary Outcome Measures

Shoulder pain and disability index
Shoulder pain and disability index is used to measure pain and functional disability level. Total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction
Universal goniometer
universal goniometer is used to measure shoulder range of motion.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2021
Last Updated
January 8, 2022
Sponsor
Health Education Research Foundation (HERF)
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1. Study Identification

Unique Protocol Identification Number
NCT05189626
Brief Title
Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.
Official Title
Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Education Research Foundation (HERF)

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
Total of 30 patients are selected according to inclusion criteria by convenient sampling and randomly allocated by sealed envelop method into two groups. Group 1 is treated with Muscle energy technique(Post isometric relaxation) and Group 2 is treated with Grade II,III Kaltenborn mobilizations and both groups also receives conventional therapy in form of Codman exercise and Wall ladder exercises.Data will be collected at baseline then after 2 weeks and after 4 weeks of intervention.
Detailed Description
The purpose of study is to determine effectiveness of muscle energy techniques(Post Isometric relaxation) and Kaltenborn mobilizations and to compare the effectiveness of both techniques on pain and functional disability in patients with Adhesive capsulitis.Several studies about the effects of Maitland mobilizations and Muscle energy technique have been conducted. Evidence regarding the comparison of Kaltenborn mobilizatuons and post isometric relaxation is sparse. There has been no work regarding effectiveness of these two techniques in improving pain and functional disability in patients of Adhesive capsulitis. Kaltonborn Mobilizations involves the application of a passive sustained stretch technique to enhance joint mobility without articular surface suppression. The forces applied to increase joint mobility are graded from I-III. Grade I applies a distraction of minor intensity that hardly causes stress within the joint capsule; it is often used to decrease pain. Grade II refers to a force that stretches the periarticular tissue; such stimulus is colloquially referred to as "taking up the slack." Finally, Grade III force causes enough distraction or gliding so that joint capsule can sufficiently stretch; it is often used for enhancing ROM. MET is unique in its application as the client provides the initial effort while the practitioner facilitates the process. One of the main uses of this method is to normalize joint range, rather than increase flexibility, and techniques can be used on any joints with restricted Range of Motion (ROM) identified during the passive assessment. The main effects of MET can be explained by two distinct physiological processes: Post Isometric Relaxation (PIR) and Reciprocal Inhibition (RI). Post isometric contraction decrease muscle tone in single group of muscle after brief period of submaximal isometric contraction of same muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder
Keywords
Adhesive Capsulitis,Mobilizations, muscle energy technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two groups Group 1 and 2.Group 1 is treated with Muscle energy techniques and Group 2 is treated with kaltenborn mobilizations for 30 minutes per session,3 days per week for 4 weeks.
Masking
ParticipantCare Provider
Masking Description
It is a single blinded study.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Muscle energy technique
Arm Title
Group B
Arm Type
Experimental
Arm Description
Kaltonborn mobilizations
Intervention Type
Other
Intervention Name(s)
Muscle energy technique
Intervention Description
Post Isometric relaxation(muscle energy technique) 3 days/ week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Kaltonborn mobilizations
Intervention Description
Kaltonborn mobilizations grade II and III will be performed on Glenohumeral joints 3 days/ week for 4 weeks.
Primary Outcome Measure Information:
Title
Shoulder pain and disability index
Description
Shoulder pain and disability index is used to measure pain and functional disability level. Total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction
Time Frame
4 weeks
Title
Universal goniometer
Description
universal goniometer is used to measure shoulder range of motion.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 20 and 60 years. Duration of complaint for more than 3 months. Gender: Both Male and Female. Patients with idiopathic frozen shoulder Patients having restriction in more than 2 ranges Patients with diabetes Exclusion Criteria: Shoulder dislocation, fracture or labral tear. Shoulder girdle motor control deficit associated with neurological disorder. Any bony deformities acquired or congenital in glenohumeral joint. Patients with language barrier.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waqar Ahmed Awan, PhD
Phone
+923335348846
Email
president@herf.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Waqar Ahmed Awan, PhD
Phone
+923335348846
Email
ce@trjournal.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aqsa Anwar, DPT
Organizational Affiliation
Rawalpindi Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy family hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
4400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nida khan, DPT
Phone
03310404000
Email
knida816@gmail.com
First Name & Middle Initial & Last Name & Degree
Aqsa Anwar, DPT
Phone
03215172551
Email
aqsaanwar.pt@gmail.com

12. IPD Sharing Statement

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Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis.

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