- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05931666
Gong v/s Kaltenborn Mobilization in Frozen Shoulder
Comparison of Gong and Kaltenborn Mobilization in Frozen Shoulder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46030
- Satellite Specialist Clinic
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Rawalpindi, Punjab, Pakistan, 48201
- Professional Specialist Rehab Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gong Mobilization
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.
|
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. |
Experimental: Kaltenborn Mobilization
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder pain and disability index
Time Frame: 3rd week
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: 3rd week
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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
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3rd week
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Shoulder ranges using Goniometer
Time Frame: 3rd week
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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
|
3rd week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Affan Iqbal, PhD*, Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPHAH/RCRS/REC/Letter-01400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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