NCT05931666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

June 6, 2023

Last Update Submit

July 25, 2023

Conditions

Keywords

Gong mobilizationKaltenborn mobilizationFrozen shoulder

Outcome Measures

Primary Outcomes (1)

  • 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 \[95% CI=0.988-0.998\]

    3rd week

Secondary Outcomes (2)

  • Visual Analogue Scale

    3rd week

  • Shoulder ranges using Goniometer

    3rd week

Study Arms (2)

Gong Mobilization

EXPERIMENTAL

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.

Other: Gong Mobilization

Kaltenborn Mobilization

EXPERIMENTAL

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.

Other: Kaltenborn Mobilization

Interventions

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.

Gong Mobilization

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.

Kaltenborn Mobilization

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Satellite Specialist Clinic

Rawalpindi, Punjab Province, 46030, Pakistan

Location

Professional Specialist Rehab Center

Rawalpindi, Punjab Province, 48201, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 5, 2023

Study Start

June 1, 2022

Primary Completion

June 15, 2023

Study Completion

June 22, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations