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Gong v/s Kaltenborn Mobilization in Frozen Shoulder

Primary Purpose

Frozen Shoulder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gong Mobilization
Kaltenborn Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Gong mobilization, Kaltenborn mobilization, Frozen shoulder

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with unilateral stage-II frozen shoulder. Both males and females. Subjects within 40- 65 years age. Capsular pattern restrictions in ROM (external rotation is more limited than abduction, which is more limited than internal rotation). Exclusion Criteria: Subjects with previous surgery of the shoulder joint. Subjects with rotator cuff rupture. History of recent fracture or severe trauma to the shoulder. Restricted shoulder ROM due to burns or postoperative scars. Diagnosed instability or previous history of dislocation Systemic inflammatory conditions (e.g. rheumatoid arthritis)

Sites / Locations

  • Satellite Specialist Clinic
  • Professional Specialist Rehab Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gong Mobilization

Kaltenborn Mobilization

Arm Description

The subject placed in a side-lying position with the affected shoulder joint facing upward. and abducted at about 90 degrees to maintain the humerus vertical position with elbow in a 90-degree position. The therapist use one hand to keep the subject's elbow joint at 90 degrees, his elbow below the subject's elbow joint, and the other hand to press the humerus head from anterior to posterior. Therapist elevate own body, pulling on the articular capsule of the shoulder joint. This gentle pulling sustained for 10- 15 seconds before relaxing for 5 seconds; the whole manoeuver last roughly 2-3 minutes.

Patient lies supine on the table with the arm abducted approximately to 55⁰. The therapist stands facing the lateral side of upper arm. The scapula is fixed using a towel. The therapist's right hand holds around the patients elbow & forearm from the ventral side. Left hand holds around the humeral head with the thumb ventrally just distal to the acromion & the direction of movement is towards caudal assisted by therapist's body. Also anterior and posterior glides are applied with patient positioned similarly in supine lying to improve mobility at the shoulder joint.

Outcomes

Primary Outcome Measures

Shoulder pain and disability index
SPADI was developed to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales i.e. pain and disability. A remarkably good internal consistency and high test-retest reliability value was found (ICC for pain=0.989 [95% CI=0.975-0.995]; ICC for disability=0.990 [95% CI=0.988-0.998]

Secondary Outcome Measures

Visual Analogue Scale
Visual Analogue Rating (VAS) is a self-report of clinical pain intensity. The scale was 10 cm long and anchored by the statements "no pain" (0-4 mm) on the left mild pain (5-44 mm), moderate pain (45-74 mm), and the most intense pain imaginable (75-100 mm) on the right. It is a reliable tool with ICC (95% CI) value 0.97 (0.96-0.98). VAS is considered to have good construct validity i.e. highly correlated with numeric rating scale and verbal rating scale with correlations values 0.941 and 0.878 respectively
Shoulder ranges using Goniometer
A device used by physical therapists to measure joints' range of motion. During measurement fulcrum will be placed on shoulder joint parallel to sagittal axis for abduction and adduction, frontal axis for flexion and extension and to humeral longitudinal axis in 90o of abduction for internal and external rotations. The intra class correlation coefficients (ICC) validity ranged from 0.945 to 0.973 for the goniometric measurements

Full Information

First Posted
June 6, 2023
Last Updated
July 25, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05931666
Brief Title
Gong v/s Kaltenborn Mobilization in Frozen Shoulder
Official Title
Comparison of Gong and Kaltenborn Mobilization in Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this research is to determine the effects of Gong mobilization and Kaltenborn mobilization in patients of frozen shoulder. This is a Randomized clinical trial. The sample size is 40. The subjects are divided in two groups, with 20 subjects in Group A and 20 subjects in Group B. Study duration is of 6 months. Sampling technique applied is Nonprobability Purposive Sampling. Both males and females of aged 40-65 years with Stage-II frozen shoulder are included. Tools used in the study are Visual Analogue Scale (VAS), Goniometer, and SPADI (Shoulder pain and disability index) questionnaire.
Detailed Description
Adhesive capsulitis or periarthritis, more commonly termed as frozen shoulder is a pathological process where adhesions are formed across glenohumeral joint causing debilitating pain and movement restrictions. The pathology is categorized as primary, being idiopathic and occur spontaneously without any inciting event, or secondary which occur as a result of some identifiable disorder such as diabetes mellitus (where a cascade of inflammatory reactions, collagen build-up and other extracellular components lead to tendon fibrosis and dysfunction, presenting as diabetic frozen shoulder) or some other inciting event. The incidence of frozen shoulder is evident to be 3-5% in general population while it's up to 20% in diabetic patients. Further it is more evident in females aged 40-60 years. Moreover frozen shoulder is classified into four stages which include Stage-I characterized by painful shoulder at rest and disturbed sleep, lasting up to 3 months; Stage-II termed the "freezing stage" is identified by chronic pain along with restrictions in range of motion (ROM) and last up to 9 months; Stage-III called the "frozen stage" where a considerable reduction in ROM and a rigid end feel is observed and occurs during 9 to 15 months of onset; Stage-IV is "thawing phase" where ROM improves progressively, as frozen shoulder is a self-limiting condition and lasts from 15 to 24 months. The standard exercise protocol followed for management of frozen shoulder include active and active assisted exercises, Codman exercises, wall and ladder exercises, wand exercises, capsular stretching, and shoulder joint mobilization. The electrotherapeutic modalities employed include ultrasound to resolve inflammation, interferential therapy and transcutaneous electrical nerve stimulation (TENS) for pain control and thermal therapy to relieve pain and improve muscles extensibility. Manual therapy techniques of mobilization have been proved to be very effective in treating frozen shoulder. The Gong's mobilization technique which combines the concepts of distraction and Maitland, is explained as end range mobilization where an antero-posterior glide is applied in dynamic position of the shoulder joint followed by distraction and performance of the restricted movement. The technique serves to reduce pain and improve range of motion and is significant in producing immediate effects. Kaltenborn mobilization technique depends on concave rule and gives grades of traction which include loosening, tightening and stretching of the soft connective tissues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
Gong mobilization, Kaltenborn mobilization, Frozen shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gong Mobilization
Arm Type
Experimental
Arm Description
The subject placed in a side-lying position with the affected shoulder joint facing upward. and abducted at about 90 degrees to maintain the humerus vertical position with elbow in a 90-degree position. The therapist use one hand to keep the subject's elbow joint at 90 degrees, his elbow below the subject's elbow joint, and the other hand to press the humerus head from anterior to posterior. Therapist elevate own body, pulling on the articular capsule of the shoulder joint. This gentle pulling sustained for 10- 15 seconds before relaxing for 5 seconds; the whole manoeuver last roughly 2-3 minutes.
Arm Title
Kaltenborn Mobilization
Arm Type
Experimental
Arm Description
Patient lies supine on the table with the arm abducted approximately to 55⁰. The therapist stands facing the lateral side of upper arm. The scapula is fixed using a towel. The therapist's right hand holds around the patients elbow & forearm from the ventral side. Left hand holds around the humeral head with the thumb ventrally just distal to the acromion & the direction of movement is towards caudal assisted by therapist's body. Also anterior and posterior glides are applied with patient positioned similarly in supine lying to improve mobility at the shoulder joint.
Intervention Type
Other
Intervention Name(s)
Gong Mobilization
Intervention Description
Patients are treated with Gong mobilization protocol along with conventional therapy including ultrasound therapy, hot pack and conventional exercises consisting of codman exercises, ROM exercises and shoulder stabilization exercises. Total of 3 sessions per week for 3 consecutive weeks.
Intervention Type
Other
Intervention Name(s)
Kaltenborn Mobilization
Intervention Description
Patients are treated with Kaltenborn mobilization protocol along with conventional therapy including ultrasound therapy, hot pack and conventional exercises consisting of codman exercises, ROM exercises and shoulder stabilization exercises. Total of 3 sessions per week for 3 consecutive weeks.
Primary Outcome Measure Information:
Title
Shoulder pain and disability index
Description
SPADI was developed to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales i.e. pain and disability. A remarkably good internal consistency and high test-retest reliability value was found (ICC for pain=0.989 [95% CI=0.975-0.995]; ICC for disability=0.990 [95% CI=0.988-0.998]
Time Frame
3rd week
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analogue Rating (VAS) is a self-report of clinical pain intensity. The scale was 10 cm long and anchored by the statements "no pain" (0-4 mm) on the left mild pain (5-44 mm), moderate pain (45-74 mm), and the most intense pain imaginable (75-100 mm) on the right. It is a reliable tool with ICC (95% CI) value 0.97 (0.96-0.98). VAS is considered to have good construct validity i.e. highly correlated with numeric rating scale and verbal rating scale with correlations values 0.941 and 0.878 respectively
Time Frame
3rd week
Title
Shoulder ranges using Goniometer
Description
A device used by physical therapists to measure joints' range of motion. During measurement fulcrum will be placed on shoulder joint parallel to sagittal axis for abduction and adduction, frontal axis for flexion and extension and to humeral longitudinal axis in 90o of abduction for internal and external rotations. The intra class correlation coefficients (ICC) validity ranged from 0.945 to 0.973 for the goniometric measurements
Time Frame
3rd week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unilateral stage-II frozen shoulder. Both males and females. Subjects within 40- 65 years age. Capsular pattern restrictions in ROM (external rotation is more limited than abduction, which is more limited than internal rotation). Exclusion Criteria: Subjects with previous surgery of the shoulder joint. Subjects with rotator cuff rupture. History of recent fracture or severe trauma to the shoulder. Restricted shoulder ROM due to burns or postoperative scars. Diagnosed instability or previous history of dislocation Systemic inflammatory conditions (e.g. rheumatoid arthritis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD*
Organizational Affiliation
Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satellite Specialist Clinic
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46030
Country
Pakistan
Facility Name
Professional Specialist Rehab Center
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
48201
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Gong v/s Kaltenborn Mobilization in Frozen Shoulder

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