Gong v/s Kaltenborn Mobilization in Frozen Shoulder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Gong and Kaltenborn Mobilization in Frozen Shoulder

Conditions
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Frozen Shoulder

Intervention / Treatment
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* Other: Gong Mobilization
* Other: Kaltenborn Mobilization


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gong Mobilization<br>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<br>* 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.<br>|
| Experimental: Kaltenborn Mobilization<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3rd week | 
| 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 | 3rd week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gong mobilization, Kaltenborn mobilization, Frozen shoulder