Clinical trial NCT06181461: Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis
Official title: Effects of Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Frozen Shoulder
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Shoulder Pain & disability Index (SPADI)
timeFrame: 3 weeks
measure: Numeric Pain Rating Scale
timeFrame: 3 weeks
measure: Universal Goniometer
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
Study officials:
affiliation: The University of Lahore
name: Sara Gull, MSPT MSK*
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Lahore
name: Hafiza Sana Ashraf, MSPT MSK
role: STUDY_DIRECTOR
References: