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Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis

NCT ID: NCT06181461

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-03-30

Brief Summary

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The study will be a Randomized Clinical Trial set to take place at the Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore. It is projected to span 9 months, beginning after the approval of the synopsis. The calculated sample size, utilizing Visual Analogue Scale as an outcome measure with a 20% dropout consideration, will be 34 in each group. Ethical approval from the Research Ethical Committee will be sought, and participant referrals will be facilitated by orthopedic physicians. Eligibility screening will be carried out, and willing participants will be randomized into Experimental and Comparative groups using a lottery method. The study will maintain single-blinding, with assessors remaining unaware of group allocation.

Detailed Description

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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.

Conditions

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Adhesive Capsulitis Frozen Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Gong's Mobilization

Intervention Type OTHER

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.

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 Type EXPERIMENTAL

Kaltenborn Mobilization

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Gull, MSPT MSK*

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Hafiza Sana Ashraf, MSPT MSK

Role: STUDY_DIRECTOR

University of Lahore

Locations

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University of Lahore Teaching Hospital

Lahore, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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REC-UOL-528-09-2023

Identifier Type: -

Identifier Source: org_study_id