- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06181461
Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis
Effects of Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Patients With Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research is centered on the comparative effectiveness of Gong's and Kaltenborn's mobilization techniques in the treatment of Adhesive Capsulitis, addressing a significant void in current literature. Prior studies have individually showcased the efficacy of both techniques in enhancing pain relief, expanding range of motion, and improving functional outcomes among patients. However, a direct comparative analysis between Gong's and Kaltenborn's mobilization is conspicuously absent, prompting this study to unveil potential distinctions in their impact on shoulder pain, range of motion, and functional mobility.
The research design involves the random allocation of participants into two groups: Group A, receiving Gong's mobilization, and Group B, undergoing Kaltenborn's mobilization. This allocation will be done through a lottery method, ensuring a fair and unbiased selection process. The study will follow a single-blind design, with the assessor remaining unaware of the treatment group assignment.
Participants in both groups will also receive routine physical therapy, including 15 minutes of electrical muscle stimulation with heat therapy. This approach, supported by existing literature, aims to create a standardized baseline for assessing the additional impact of mobilization techniques. The study's duration is projected to be nine months, with data collection points at baseline, the end of 1.5 weeks, and the conclusion of the 3rd week.
Outcome variables include pain assessment using the Numeric Pain Rating Scale, evaluation of function through the Shoulder Pain & Disability Index, and measurement of range of motion using goniometry. Data collection will be performed by an assessor at specified intervals, allowing for a comprehensive understanding of the interventions' effects over time.
Ultimately, this research aspires to contribute evidence-based insights into the relative effectiveness of Gong's and Kaltenborn's mobilization techniques, aiding clinicians in making informed decisions for optimal patient outcomes in the context of Adhesive Capsulitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lahore, Pakistan
- University of Lahore Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 40-60 years
- Both Male and females
- Patients diagnosed with idiopathic Adhesive Capsulitis
- Patients with 2nd and 3rd stage of Adhesive Capsulitis
- Having at least 5 score of Numeric Pain Rating Scale
Exclusion Criteria:
- Patients with neurological disorders(Thoracic Outlet Syndrome)
- Patients with musculoskeletal disorder(e.g. Rotator Cuff Injury)
- Recent fracture/dislocation in and around the shoulder
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's Mobilization
Group A received Gong's mobilization with routine physical therapy included a 30-45 min session with 15-min TENS.
Patients followed daily care instructions, using the affected shoulder in daily activities, and performed pendulum and active shoulder exercises twice a day.
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Group A received Gong's mobilization with routine physical therapy included a 30-45 min session with 15-min TENS.
Patients followed daily care instructions, using the affected shoulder in daily activities, and performed pendulum and active shoulder exercises twice a day.
|
|
Experimental: Kaltenborn Mobilization
Group B will receive Kaltenborn mobilization (Grade III posterior translation) with routine therapy.
Posterior translation is applied in 30-sec sets, repeated 15 times over 10 mins, with 10-sec rests.
Routine physical therapy includes 30-45 min sessions with 15-min TENS.
Patients follow daily care instructions, use the affected shoulder in daily activities, and perform pendulum and active shoulder exercises twice a day.
|
Group B will receive Kaltenborn mobilization (Grade III posterior translation) with routine therapy.
Posterior translation is applied in 30-sec sets, repeated 15 times over 10 mins, with 10-sec rests.
Routine physical therapy includes 30-45 min sessions with 15-min TENS.
Patients follow daily care instructions, use the affected shoulder in daily activities, and perform pendulum and active shoulder exercises twice a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Shoulder Pain & disability Index (SPADI)
Time Frame: 3 weeks
|
The Shoulder Pain & Disability Index (SPADI) was designed to evaluate shoulder pain and impairment in an outpatient setting.
Comprising 13 items, it assesses two domains: a 5-item pain subscale and an 8-item disability subscale.
In contrast to the Visual Analog Scale (VAS), the SPADI utilizes a 0-10 scale, with patients circling the number that best represents their pain or disability level, ranging from 0 for minor pain to 10 for severe pain.
The total score is calculated similarly to the VAS version.
Patients have the option to deem one item as not applicable in each subscale, and that specific item is excluded from the overall score, offering a comprehensive yet adaptable assessment of shoulder pain and disability.
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3 weeks
|
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Numeric Pain Rating Scale
Time Frame: 3 weeks
|
The Numeric Pain Rating Scale (NPRS) serves as a segmented numeric alternative to the Visual Analog Scale (VAS), allowing respondents to choose a whole number (0-10 integers) that most accurately represents the intensity of their pain.
Typically presented as a horizontal bar or line, the NPRS is a quick and straightforward assessment tool, taking less than a minute to complete.
Scores on the NPRS range from 0 to 10 points, with higher scores indicative of more intense pain.
This scale is versatile, as it can be administered verbally, making it suitable for telephone assessments, or graphically for self-completion, offering a practical means of gauging pain intensity.
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3 weeks
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Universal Goniometer
Time Frame: 3 weeks
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The universal goniometer is a crucial tool for assessing shoulder range of motion (ROM).
With its protractor-like design, it allows precise measurement of angles in various planes, aiding clinicians in objectively evaluating flexion, extension, abduction, adduction, internal rotation, and external rotation.
This device, aligned with joint axes, provides quantitative data for diagnosing conditions, monitoring progress, and guiding treatment plans in orthopedics and rehabilitation.
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3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hafiza Sana Ashraf, MSPT MSK, The University of Lahore
- Principal Investigator: Sara Gull, MSPT MSK*, The University of Lahore
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
- REC-UOL-528-09-2023
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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