Effectiveness of Kaltenborn Mobilizations Versus Muscle E... | NCT05189626

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

NCT05189626

Sponsor

Health Education Research Foundation (HERF)

Status

Unknown status

Last Update Posted

Jan 12, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Adhesive Capsulitis of Shoulder

Interventions

Muscle energy technique
Kaltonborn mobilizations

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2021Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Mar 31, 2022Estimated

First Submitted Date

Dec 11, 2021

First Submission Date that Met QC Criteria

Jan 8, 2022

First Posted Date

Jan 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2022

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Muscle energy technique	Other: Muscle energy technique
Group B	Experimental	Kaltonborn mobilizations	Other: Kaltonborn mobilizations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Muscle energy technique	Other	Post Isometric relaxation(muscle energy technique) 3 days/ week for 4 weeks	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	4 weeks
Universal goniometer	universal goniometer is used to measure shoulder range of motion.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Waqar Ahmed Awan, PhD	Contact	+923335348846		president@herf.org.pk
Waqar Ahmed Awan, PhD	Contact	+923335348846		ce@trjournal.org

Overall Officials

Name	Affiliation	Role
Aqsa Anwar, DPT	Rawalpindi Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holy family hospital	Recruiting	Rawalpindi	Punjab Province	4400	Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D002062	Bursitis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.