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

NCT06181461 | Completed

• 1 other identifier: REC-UOL-528-09-2023
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis; Frozen Shoulder

Outcome Measures

Primary Outcomes (3)

• The Shoulder Pain & disability Index (SPADI)

  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.

  3 weeks

• Numeric Pain Rating Scale

  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.

  3 weeks

• Universal Goniometer

  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.

  3 weeks

Study Arms (2)

Gong's Mobilization

EXPERIMENTAL

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.

Other: Gong's Mobilization

Kaltenborn Mobilization

EXPERIMENTAL

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.

Other: Kaltenborn Mobilization

Interventions

Gong's Mobilization 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.

Gong's Mobilization

Kaltenborn Mobilization 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.

Kaltenborn Mobilization

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with neurological disorders(Thoracic Outlet Syndrome)
• Patients with musculoskeletal disorder(e.g. Rotator Cuff Injury)
• Recent fracture/dislocation in and around the shoulder

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Sara Gull, MSPT MSK*

  University of Lahore

  PRINCIPAL INVESTIGATOR

• Hafiza Sana Ashraf, MSPT MSK

  University of Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 26, 2023
• Study Start: September 28, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 30, 2024
• Last Updated: December 16, 2024

Record last verified: 2023-12

Locations

PA (1)