3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.

NCT ID: NCT06530602

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2025-01-10

Brief Summary

Ongoing research aims to assess the enhancement of shoulder mobility by specifically addressing restrictions in all three planes of movement. current studies seek to investigate the impact of three-dimensional mobilization technique on their recovery and to prevent progression of disease to reduce pain, alleviate muscle tightness, facilitate tissue healing, and ultimately improve the range of motion in patients. A randomized control trial that will include total 36 participants. The first group will receive 3 Dimensional shoulder pain alignment (3-D SPA) mobilization along with conventional therapy and 2nd group will receive Shoulder mobilization along with conventional therapy. Data collected will be analyzed through SPSS 27.

Detailed Description

Decrease capacity of non contractile tissue ( such as joint capsule ) inflammation of capsule and ligament adhesion affects the shoulder joint, triggering stiffness and pain in Frozen shoulder. About 2% to 5% of the general population reported frozen shoulder without well known cause defined ,out of which Female patients 35 - 65 years of age.

hindrance in quality of life reported with performance of basic activities of daily living due to pain that worsen with movement and specifically at night , stiffness that cause mobility deficit.70% of female population are prone to get frozen shoulder. When reaching overhead, the arm is lifted by movements in the sternoclavicular , acromioclavicular (AC), scapulothoracic (ST), and gleno-humeral joints while overhead activities got limited in frozen shoulder.

Abnormal glenohumeral rhythm at scapulothoracic joint by posterior tilting of scapula and early upward motion of scapula occur. hence a capsular pattern developed in patient that comprise of External rotation, Abduction and Internal rotation.

Physiotherapy encompassed variety of treatment protocols for frozen shoulder including therapeutic modalities and manual therapy technique's consisting moblization, muscle energy techniques ,spencer's technique ,PNF and some of invasive treatments dry needling and therapeutic exercises.

3 D SPA is latest technique with no literature available for this to be applied to check its effectiveness on frozen shoulder rather it merely applied for post stroke shoulder pain prior in clinical setting . In group A 3-D SPA Moblization is employed that target moblization of AC joint (mobilizing it upward posteriorly) synchronously Scapula mobilized (abduction-adduction, anterior-posterior tilting) with glenohumeral Active motion in (flexion, horizontal abduction, horizontal adduction & External Internal rotation) all at once in all 3 planes frontal, sagittal, transverse plane while kaltenborn mobilization in anterior, posterior and inferior direction that is employed in group B, that has been a treatment of choice over the time is effective to treat frozen shoulder.

the study aim to evaluate the effect of 3-Dimensional Shoulder complex Pain Alignment (3-D SPA) mobilization technique on pain, disability, Range of Motion and quality of life.

Conditions

Frozen Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

3-D SPA (shoulder complex pain alignment) Moblization. Conventional therapy & Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min

Group Type: EXPERIMENTAL

3 D SPA (shoulder complex pain alignment) Moblization

Intervention Type: OTHER

3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Group B

Shoulder mobilization (kaltenborn) Conventional therapy & Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min

Group Type: ACTIVE_COMPARATOR

Shoulder Moblization (KaltenBorn)

Intervention Type: OTHER

3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Interventions

3 D SPA (shoulder complex pain alignment) Moblization

3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Intervention Type: OTHER

Shoulder Moblization (KaltenBorn)

3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Local shoulder pain, often present either above the antero-medial and Lateral aspect of the shoulder.
• Stage II& III unilateral frozen shoulder Symptoms.
• Marked loss Of AROM & PROM with at least 50%loss of external rotation.
• Positive Apley's Scratch test.

Exclusion Criteria

• Radiculopathy.
• Thoracic-outlet syndrome.
• Fractures and tumors of the upper extremity.
• Neurological disorders causing muscle weakness in the shoulder.
• Corticosteroid injection for frozen shoulder in last 3 months.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madiha Ali, MSOMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Madiha Ali, MSOMPT

Role: CONTACT

madiha.ali@riphah.edu.pk

0331-3360064

Facility Contacts

Madiha Ali, MSOMPT

Role: primary

madiha.ali@riphah.edu.pk

0331-3360064

Other Identifiers

Muniba

Identifier Type: -

Identifier Source: org_study_id